125742 S1 M5 CRF c4591001 1251 12511239

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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Page 1 of 442
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version06 OCT 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832613
Page 2 of 442
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/13/2020
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832614
Page 3 of 442
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12511239]
2.Birth Date: /1972
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832615
Page 4 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832616
Page 5 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832617
Page 6 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832618
Page 7 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Mellitus Type II]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sulfa Allergy]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832619
Page 8 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Congestive Heart Failure]
Start Date: UNK/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholecystectomy]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2014
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy Partial]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832620
Page 9 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heavy Mentrual Bleeding]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Knee Pain B/L]
Start Date: UNK/UNK/2017
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fluid Retention]
Start Date: UNK/UNK/2018
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tubal Ligation]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832621
Page 10 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholecystitis]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2006
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chest pain]
Start Date: Aug/UNK/2020
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergies Seasonal]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832622
Page 11 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic Neuropathy]
Start Date: Nov/21/2014
Ongoing: YES
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis Knee Bilateral]
Start Date: UNK/UNK/2017
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Schizophrenia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832623
Page 12 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832624
Page 13 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
2.Weight: [263.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [43.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832625
Page 14 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832626
Page 15 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/13/2020
2.Randomization Number: [106973]
3.Randomization Group: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832627
Page 16 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR90NX]
5.bSample ID [BNWBMN]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832628
Page 17 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR910K]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832629
Page 18 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/13/2020 12:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832630
Page 19 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832631
Page 20 of 442
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832632
Page 21 of 442
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832633
Page 22 of 442
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832634
Page 23 of 442
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR914K]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832635
Page 24 of 442
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/2/2020 11:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832636
Page 25 of 442
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832637
Page 26 of 442
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/30/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8ZVG]
5.bSample ID [BM8ZVH]
5.cSample ID [BM8ZVJ]
5.dSample ID [BSHZ52]
5.eSample ID [BSHZ53]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832638
Page 27 of 442
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832639
Page 28 of 442
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832640
Page 29 of 442
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832641
Page 30 of 442
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832642
Page 31 of 442
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832643
Page 32 of 442
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832644
Page 33 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832645
Page 34 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/17/2020
2.Date of First Symptom Started: Nov/13/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/16/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832646
Page 35 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832647
Page 36 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/13/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832648
Page 37 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/13/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: INDETERMINATE
8.Comments/Findings/Details: [Results are unknown.]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832649
Page 38 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV51555]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832650
Page 39 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject has been instructed to collect home self-swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832651
Page 40 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832652
Page 41 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832653
Page 42 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Treatment Start DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832654
Page 43 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832655
Page 44 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 4
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832656
Page 45 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832657
Page 46 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832658
Page 47 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Appli
cable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832659
Page 48 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832660
Page 49 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832661
Page 50 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832662
Page 51 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832663
Page 52 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category fo
r Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applica
ble Not Applicable  Not Appli
cable Not Appl
icable Sponsor-Defin
ed IdentifierTest: Result:
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable 
Not Applicable  Not App
licable Not App
licable Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832664
Page 53 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832665
Page 54 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832666
Page 55 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832667
Page 56 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832668
Page 57 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832669
Page 58 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832670
Page 59 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832671
Page 60 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832672
Page 61 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832673
Page 62 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832674
Page 63 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832675
Page 64 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832676
Page 65 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832677
Page 66 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832678
Page 67 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832679
Page 68 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832680
Page 69 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/18/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832681
Page 70 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/18/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Poor venous access no sample collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832682
Page 71 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832683
Page 72 of 442
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832684
Page 73 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Iden
tifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. DELETED ADVERSE
EVENT 1  Chest Pain  Aug/UNK/2020
UNK:UNK NO
End Date Time:
Oct/30/2020 UNK:
UNK
 Repeating
Pages
 2. ADVERSE
EVENT 2  Myocardial i
schemia Nov/13/2020 UN
K:UNK NO
End Date Time:
Nov/16/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832685
Page 74 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chest Pain ]
4.Start Date Time: Aug/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/30/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832686
Page 75 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Previous Chest Pain Secondary to Congestive Heart Failure ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832687
Page 76 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Myocardial ischemia]
4.Start Date Time: Nov/13/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/16/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832688
Page 77 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Congestive Heart Failure]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020455312]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832689
Page 78 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication
ErrorStart DateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.Not Applic
able Not Applicab
le Not Applic
able Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832690
Page 79 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment
given?Not Applicable Comments
8.Did the Medication Error cause
the subject to be discontinued
from the study?Not Applicable Comments
9.Was this medication error
associated with any adverse
events?Not Applicable Comments
10.Serious Adverse Event Number:
For Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832691
Page 80 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832692
Page 81 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832693
Page 82 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Applic
able Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832694
Page 83 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832695
Page 84 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Start DateForm Instanc
e
 1.Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832696
Page 85 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832697
Page 86 of 442
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832698
Page 87 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832699
Page 88 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832700
Page 89 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832701
Page 90 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832702
Page 91 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832703
Page 92 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832704
Page 93 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832705
Page 94 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832706
Page 95 of 442
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832707
Page 96 of 442
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832708
Page 97 of 442
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832709
Page 98 of 442
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832710
Page 99 of 442
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832711
Page 100 of 442
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832712
Page 101 of 442
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832713
Page 102 of 442
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832714
Page 103 of 442
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832715
Page 104 of 442
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832716
Page 105 of 442
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832717
Page 106 of 442
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832718
Page 107 of 442
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/30/2020
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832719
Page 108 of 442
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832720
Page 109 of 442
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0832721
Page 110 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-14-2020 11:26:32 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832722
Page 111 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormOct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832723
Page 112 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Oct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832724
Page 113 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Oct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832725
Page 114 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Oct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832726
Page 115 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Oct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832727
Page 116 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Oct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832728
Page 117 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832729
Page 118 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832730
Page 119 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aOct-14-2020 11:38:28 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832731
Page 120 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832732
Page 121 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832733
Page 122 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832734
Page 123 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832735
Page 124 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832736
Page 125 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832737
Page 126 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832738
Page 127 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832739
Page 128 of 442
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aNov-03-2020 12:59:55 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832740
Page 129 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832741
Page 130 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832742
Page 131 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832743
Page 132 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832744
Page 133 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832745
Page 134 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832746
Page 135 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-18-2020 10:52:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832747
Page 136 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:54:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832748
Page 137 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:54:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832749
Page 138 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:54:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832750
Page 139 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:54:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832751
Page 140 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-18-2020 10:54:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832752
Page 141 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832753
Page 142 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832754
Page 143 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832755
Page 144 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832756
Page 145 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832757
Page 146 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832758
Page 147 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832759
Page 148 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832760
Page 149 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832761
Page 150 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832762
Page 151 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832763
Page 152 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832764
Page 153 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832765
Page 154 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832766
Page 155 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832767
Page 156 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832768
Page 157 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832769
Page 158 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832770
Page 159 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832771
Page 160 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832772
Page 161 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832773
Page 162 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832774
Page 163 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832775
Page 164 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832776
Page 165 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832777
Page 166 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832778
Page 167 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832779
Page 168 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832780
Page 169 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832781
Page 170 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832782
Page 171 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832783
Page 172 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832784
Page 173 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:54:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832785
Page 174 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832786
Page 175 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832787
Page 176 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832788
Page 177 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832789
Page 178 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832790
Page 179 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832791
Page 180 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832792
Page 181 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832793
Page 182 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832794
Page 183 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832795
Page 184 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832796
Page 185 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832797
Page 186 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832798
Page 187 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832799
Page 188 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832800
Page 189 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832801
Page 190 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832802
Page 191 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832803
Page 192 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832804
Page 193 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832805
Page 194 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832806
Page 195 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832807
Page 196 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832808
Page 197 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832809
Page 198 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832810
Page 199 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832811
Page 200 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832812
Page 201 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832813
Page 202 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832814
Page 203 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832815
Page 204 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832816
Page 205 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832817
Page 206 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832818
Page 207 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832819
Page 208 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832820
Page 209 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832821
Page 210 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832822
Page 211 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832823
Page 212 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832824
Page 213 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832825
Page 214 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832826
Page 215 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832827
Page 216 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832828
Page 217 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832829
Page 218 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jNov-18-2020 10:55:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832830
Page 219 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
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Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:55:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832831
Page 220 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:55:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832832
Page 221 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-18-2020 10:55:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832833
Page 222 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-18-2020 10:55:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832834
Page 223 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-18-2020 10:55:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832835
Page 224 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-18-2020 10:55:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832836
Page 225 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:55:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832837
Page 226 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:55:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832838
Page 227 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aNov-18-2020 10:55:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832839
Page 228 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:56:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832840
Page 229 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:56:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832841
Page 230 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:56:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832842
Page 231 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:56:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832843
Page 232 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832844
Page 233 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832845
Page 234 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832846
Page 235 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832847
Page 236 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832848
Page 237 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832849
Page 238 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-18-2020 10:57:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832850
Page 239 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-18-2020 10:57:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832851
Page 240 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-18-2020 10:57:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832852
Page 241 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-18-2020 10:57:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832853
Page 242 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-18-2020 10:57:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832854
Page 243 of 442
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/17/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-18-2020 10:57:26 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832855
Page 244 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832856
Page 245 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832857
Page 246 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832858
Page 247 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832859
Page 248 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832860
Page 249 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832861
Page 250 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832862
Page 251 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832863
Page 252 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832864
Page 253 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832865
Page 254 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-03-2020 13:15:57 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832866
Page 255 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 13:16:46 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832867
Page 256 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 13:16:46 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832868
Page 257 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 13:16:46 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832869
Page 258 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 13:16:46 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832870
Page 259 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 13:16:46 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832871
Page 260 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-03-2020 13:16:46 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832872
Page 261 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832873
Page 262 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832874
Page 263 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832875
Page 264 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832876
Page 265 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832877
Page 266 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832878
Page 267 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832879
Page 268 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832880
Page 269 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832881
Page 270 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832882
Page 271 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Nov-03-2020 13:19:19 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832883
Page 272 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832884
Page 273 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832885
Page 274 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832886
Page 275 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832887
Page 276 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832888
Page 277 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Nov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832889
Page 278 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-03-2020 13:19:38 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832890
Page 279 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-03-2020 13:19:56 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832891
Page 280 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 13:19:56 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832892
Page 281 of 442
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-03-2020 13:19:56 (UTC-06:00) Central
Time (US & Canada)NA
Not Applicable
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0832893
Page 282 of 442
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-05-2021 13:48:09 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hayes
Williams Approved Jan-20-2021 15:00:56 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HayesWilliams, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832894
Page 283 of 442
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-14-2020 11:25:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-14-2020 11:25:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832895
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***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020 11:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Oct/13/2020Initial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832896
Page 285 of 442
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020 11:25:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12511239Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020 11:24:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020 11:25:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-14-2020 11:25:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020 11:25:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AME
RICANInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832897
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***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 11:26:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832898
Page 287 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-14-2020 11:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 11:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020 11:26:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832899
Page 288 of 442
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020 11:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Postmenopa
usal
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PostmenopausalInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-14-2020 11:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832900
Page 289 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-14-2020 11:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-14-2020 11:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832901
Page 290 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020 11:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020 11:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-14-2020 11:28:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Diabetes Mellit
us Type II
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832902
Page 291 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:28:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:28:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes Mellitus Type IIInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-14-2020 11:28:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-14-2020 11:28:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-14-2020 11:29:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Sulfa Allerg
y
Start Date: UNK/UNK/
2017
Ongoing: YESInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832903
Page 292 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.d Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:29:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:29:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sulfa AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-14-2020 11:29:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-14-2020 11:29:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-14-2020 11:30:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:Congestive He
art Failure
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832904
Page 293 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:30:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:30:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Congestive Heart FailureInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-14-2020 11:30:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-14-2020 11:30:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-14-2020 11:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Cholecystecto
my
Start Date: UNK/UNK/20
11Initial Entry
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832905
Page 294 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: NO
End Date:
UNK/UNK
/2011
1.f Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CholecystectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-14-2020 11:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-14-2020 11:31:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.g
Date Location User Value Reason
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832906
Page 295 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-14-2020 11:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Hypercholeste
rolemia
Start Date: UNK/UNK/20
14
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Oct-14-2020 11:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 11:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-14-2020 11:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-14-2020 11:31:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
090177e196ae3d07\Final\Final On: 01-Apr-2021 04:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0832907
Page 296 of 442
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1251 Site Name: (1251) Achieve Clinical Research
Subject No: 12511239 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-14-2020 11:32:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Hysterectomy
Partial
Start Date: UNK/UNK/20
10
Ongoing: NO
End Date:
U
…[truncated]