125742 S1 M5 CRF c4591001 1270 12701057

Document text

Page 1 of 720
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838802
Page 2 of 720
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
Sep/3/2020
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838803
Page 3 of 720
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12701057]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0838804
Page 4 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838805
Page 5 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838806
Page 6 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838807
Page 7 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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:[Asthma]
Start Date: Jan/5/2011
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: Jun/5/2011
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Mellitus 2]
Start Date: Jul/6/2011
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: Jul/6/2011
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Factor V Leiden Mutation, heterozygous]
Start Date: Jul/6/2011
Ongoing: YES
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838808
Page 8 of 720
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Peripheral neuropathy]
Start Date: Nov/21/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile dysfunction]
Start Date: Nov/21/2016
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Deep Vein Thrombosis of bilateral legs]
Start Date: Jul/6/2011
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Genital Herpes Simplex]
Start Date: Apr/3/2020
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Spinal stenosis of lumbar spine with neurogenic claudication]
Start Date: Jul/28/2011
Ongoing: YES
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838809
Page 9 of 720
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: Sep/20/2017
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Actinic keratosis]
Start Date: Sep/20/2017
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Dec/18/2017
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar radiculopathy]
Start Date: May/11/2018
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arthritis of bilateral hips]
Start Date: Feb/27/2019
Ongoing: YES
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838810
Page 10 of 720
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis of right knee]
Start Date: Feb/27/2019
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic pain syndrome]
Start Date: Mar/7/2019
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Tramadol]
Start Date: May/30/2019
Ongoing: YES
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838811
Page 11 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [91.5]
3.Unit: kg
4.Height: [177.8]
5.Unit: cm
6.Body Mass Index: [28.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838812
Page 12 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [251186]
3.Randomization Group: [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838813
Page 13 of 720
***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, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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:
Sep/3/2020
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 [BP1FBV]
5.bSample ID [BP1FBW]
5.cSample ID [BP1FBX]
5.dSample ID [BPJ33W]
5.eSample ID [BPJ33X]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838814
Page 14 of 720
***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, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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:
Sep/3/2020
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 [BP1DWL]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838815
Page 15 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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: Sep/3/2020 11:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838816
Page 16 of 720
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838817
Page 17 of 720
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Comments
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838818
Page 18 of 720
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838819
Page 19 of 720
***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, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [BP1F3S]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838820
Page 20 of 720
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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?YES
Date of First Delay:
Sep/24/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location:
6.Body Side: Not Done Comments
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?Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838821
Page 21 of 720
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838822
Page 22 of 720
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838823
Page 23 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838824
Page 24 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838825
Page 25 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838826
Page 26 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838827
Page 27 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838828
Page 28 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838829
Page 29 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838830
Page 30 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/24/2020
2.Date of First Symptom Started: Sep/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/8/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838831
Page 31 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.aSymptoms - Other Text: [Tightening of chest]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838832
Page 32 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Sep/24/202
0 SWABBED M
ATERIAL NASOPHARYNX
 SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
 2.Sep/28/202
0 SWABBED M
ATERIAL NASOPHARYNX
 SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838833
Page 33 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/24/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [SARS-COV-2, Qualitative, NAA (Covid-19)] Comments
9.Trade Name Other, Specify: [SARS COV-2 TEST CLIA CERTIFIED LAB] Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838834
Page 34 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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: Sep/28/2020
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: NEGATIVE
8.Comments/Findings/Details: [NOT DETECTED]
9.Trade Name Other, Specify: [SARS-COV-2 test CLIA Certified Lab] Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838835
Page 35 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB_SELF Comments
3.Sample Collected? YES
Date of Collection:
Sep/29/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV27275]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838836
Page 36 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[SEE SELF SWAB] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838837
Page 37 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[6]Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ] Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838838
Page 38 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838839
Page 39 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838840
Page 40 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Pulmonary Embolism]
Date of Diagnosis:
Sep/25/2020Comments
3.Toxicity Grade: 4 Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838841
Page 41 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838842
Page 42 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838843
Page 43 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.CLINICAL CHE
MISTRY Kaiser Lab test Rosevi
lle Riverside Sep/24/202
0 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
329  Not Appli
cable  
30  Not Appli
cable  
28  Not Appli
cable  
35  Not Appli
cable  
21  Not Appli
cable  
47  Not Appli
cable  
48  Not Appli
cable 1.06 Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838844
Page 44 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 2.CLINICAL C
HEMISTRY KAISER Lab Test Ro
seville Riverside Sep/25/2
020 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 [ ] 
30  Alanine Aminotran
sferase_PX30 [ ] 
28  Aspartate Aminotr
ansferase_PX28 [ ] 
35  Alkaline Phosphata
se_PX35 [ ] 
21  Bilirubin_PX21  [ ] 
47  Blood Urea Nitrog
en_PX47 [ ] 
48  Creatinine_PX48  1.06
 Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838845
Page 45 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [Kaiser Lab test Roseville Riverside] Comments
3.Collection Date: Sep/24/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838846
Page 46 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5 fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838847
Page 47 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [1.06] Comments
Not Done: Comments
LNMT Low
[0]
High
[1.34]
Unit
mg/dLComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838848
Page 48 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [KAISER Lab Test Roseville Riverside]
3.Collection Date: Sep/25/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838849
Page 49 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838850
Page 50 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.06]
Not Done:
LNMT Low
[0]
High
[1.34]
Unit
mg/dL
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838851
Page 51 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERI
VED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.HEMATOLOG
Y Kaiser Lab Test Rosevi
lle Riverside Sep/24/202
0 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
1  Not Appli
cable 12.3 
2  Not Appli
cable 37.2 
3  Not Appli
cable  
5  Not Appli
cable 223 
7  Not Appli
cable  
608  Not Appli
cable 43 
609  Not Appli
cable 0 
612  Not Appli
cable 15 
610  Not Appli
cable 0 
611  Not Appli
cable 41 Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838852
Page 52 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERI
VED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 2.HEMATOLO
GY KAISER Lab Test Rose
ville Riverside Sep/25/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin_
PX1 12.2 
2  Hematocrit_P
X2 37.0 
[ ]  Erythrocytes
_PX3 [ ] 
5  Platelets_PX
5 224 
[ ]  Leukocytes_
PX7 [ ] 
608  Neutrophils_
PX608 33 
609  Eosinophils_
PX609 0 
612  Monocytes_P
X612 18 
610  Basophils_P
X610 1 
611  Lymphocytes
_PX611 48 Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838853
Page 53 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY Comments
2.Laboratory Name and Address [Kaiser Lab Test Roseville Riverside] Comments
3.Collection Date: Sep/24/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [12.3] Comments
Not Done: Comments
LNMT Low
[13.0]
High
[17.0]
Unit
g/dLComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [37.2] Comments
Not Done: Comments
LNMT Low
[39.0]
High
[51.0]
Unit
%Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838854
Page 54 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3] Comments
Test: Erythrocytes_PX3
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
5.dSponsor ID: [5] Comments
Test: Platelets_PX5
Result: [223] Comments
Not Done: Comments
LNMT Low
[140]
High
[400]
Unit
10^3/uLComments
5.eSponsor ID: [7] Comments
Test: Leukocytes_PX7
Result: [ ] Comments
Not Done: NOT DONE Comments
LNMT Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838855
Page 55 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [608] Comments
Test: Neutrophils_PX608
Result: [43] Comments
Not Done: Comments
LNMT Low
[42]
High
[76]
Unit
%Comments
5.gSponsor ID: [609] Comments
Test: Eosinophils_PX609
Result: [0] Comments
Not Done: Comments
LNMT Low
[0]
High
[7]
Unit
%Comments
5.hSponsor ID: [612] Comments
Test: Monocytes_PX612
Result: [15] Comments
Not Done: Comments
LNMT Low
[5]
High
[13]
Unit
%Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838856
Page 56 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610] Comments
Test: Basophils_PX610
Result: [0] Comments
Not Done: Comments
LNMT Low
[0]
High
[1]
Unit
%Comments
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [41] Comments
Not Done: Comments
LNMT Low
[15]
High
[47]
Unit
%Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838857
Page 57 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [KAISER Lab Test Roseville Riverside]
3.Collection Date: Sep/25/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.2]
Not Done:
LNMT Low
[13.0]
High
[17.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [37.0]
Not Done:
LNMT Low
[39.0]
High
[51.0]
Unit
%
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838858
Page 58 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [ ]
Test: Erythrocytes_PX3
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [224]
Not Done:
LNMT Low
[140]
High
[400]
Unit
/uL
5.eSponsor ID: [ ]
Test: Leukocytes_PX7
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838859
Page 59 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [33]
Not Done:
LNMT Low
[42]
High
[76]
Unit
%
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [18]
Not Done:
LNMT Low
[5]
High
[13]
Unit
%
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838860
Page 60 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [1]
Not Done:
LNMT Low
[0]
High
[1]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [48]
Not Done:
LNMT Low
[15]
High
[47]
Unit
%
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838861
Page 61 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838862
Page 62 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838863
Page 63 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838864
Page 64 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838865
Page 65 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838866
Page 66 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838867
Page 67 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applic
able Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838868
Page 68 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838869
Page 69 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assess
mentLocation of Assess
mentImaging Met
hodOverall Assessment Form Instance
 1.Sep/25/2020  CHEST  CT SCAN  ABNORMAL
If abnormal, specify findings:
CT POSITIVE FOR ACUTE PUMONARY E
MBOLISM
 Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838870
Page 70 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/25/2020 Comments
2.Location of Assessment: CHEST Comments
3.Type of Imaging Exam: CT SCAN Comments
4.Assessment: ABNORMAL
If abnormal, specify findings:
[CT POSITIVE FOR ACUTE PUMONARY EMBOLISM]Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838871
Page 71 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit ERRONEOUS VISIT Comments
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838872
Page 72 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838873
Page 73 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838874
Page 74 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descript
ionDevice Type Form Instance
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838875
Page 75 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838876
Page 76 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838877
Page 77 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838878
Page 78 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?Not Applicable Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838879
Page 79 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838880
Page 80 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838881
Page 81 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Done Comments
3.Toxicity Grade: Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838882
Page 82 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838883
Page 83 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838884
Page 84 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838885
Page 85 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838886
Page 86 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838887
Page 87 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838888
Page 88 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838889
Page 89 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838890
Page 90 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838891
Page 91 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838892
Page 92 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838893
Page 93 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838894
Page 94 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838895
Page 95 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838896
Page 96 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838897
Page 97 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838898
Page 98 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838899
Page 99 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838900
Page 100 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838901
Page 101 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838902
Page 102 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838903
Page 103 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838904
Page 104 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838905
Page 105 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Sep/25/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838906
Page 106 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/02/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838907
Page 107 of 720
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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/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 [BRFF3R]
5.bSample ID [BPJ2TR]
5.cSample ID [BPJ2V5]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838908
Page 108 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838909
Page 109 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838910
Page 110 of 720
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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/2/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838911
Page 111 of 720
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Jan/12/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Subject plans to have COVID19 Vaccine outside of study on 12JAN2021]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838912
Page 112 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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:
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838913
Page 113 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838914
Page 114 of 720
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Pulmonary emboli
sm Sep/23/2020 UNK:U
NK YES  Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838915
Page 115 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pulmonary embolism]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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).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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
YES
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:
[Factor V Leiden Mutation]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838916
Page 116 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020373624]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838917
Page 117 of 720
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Err
orStart Da
teIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838918
Page 118 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838919
Page 119 of 720
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1. DELETED 1  VACCINATION
S NO  COVID 19 VA
CCINE Jan/12/2
021 Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838920
Page 120 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[COVID 19 VACCINE ]
5.Date: Jan/12/2021
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838921
Page 121 of 720
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838922
Page 122 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
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).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838923
Page 123 of 720
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838924
Page 124 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838925
Page 125 of 720
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838926
Page 126 of 720
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838927
Page 127 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838928
Page 128 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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:
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838929
Page 129 of 720
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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?
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838930
Page 130 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838931
Page 131 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838932
Page 132 of 720
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838933
Page 133 of 720
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838934
Page 134 of 720
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838935
Page 135 of 720
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838936
Page 136 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838937
Page 137 of 720
***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, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838938
Page 138 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: OTHER
If other, specify:
[Participant requests to receive vaccine outside of study]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838939
Page 139 of 720
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Jan/12/2021 Comments
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838940
Page 140 of 720
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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: [ ]
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838941
Page 141 of 720
***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: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/12/2021
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838942
Page 142 of 720
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838943
Page 143 of 720
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 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
Name Signature
MeaningDate Type Action
Nicola Klein  Approved Mar-09-2021 15:44:46 (UTC-08:00) Pacific Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NicolaKlein, 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.
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0838944
Page 144 of 720
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-03-2020 15:21:26 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao N/A
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838945
Page 145 of 720
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-03-2020 10:03:48 (UTC-08:00) Pacific Time
(US & Canada)
1Nov-03-2020 10:03:25 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838946
Page 146 of 720
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-06-2020 11:13:42 (UTC-08:00) Pacific Time
(US & Canada)DATA CHANGED TO SATISFY QUERY
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838947
Page 147 of 720
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Nov-06-2020 11:14:02 (UTC-08:00) Pacific Time
(US & Canada)DATA CHANGED TO SATISFY QUERY
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838948
Page 148 of 720
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Nov-06-2020 11:14:24 (UTC-08:00) Pacific Time
(US & Canada)DATA CHANGED TO SATISFY QUERY
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838949
Page 149 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838950
Page 150 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838951
Page 151 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838952
Page 152 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838953
Page 153 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
4Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838954
Page 154 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
5Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838955
Page 155 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
6Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838956
Page 156 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
7Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838957
Page 157 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Sep-29-2020 17:36:32 (UTC-08:00) Pacific Time
(US & Canada)Nasopharynx/Oropharynx Source
8Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
8Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838958
Page 158 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-21-2020 15:29:05 (UTC-08:00) Pacific Time
(US & Canada)KAISER CLIA CERTIFIED LAB
9Sep-29-2020 17:34:00 (UTC-08:00) Pacific Time
(US & Canada)
9Sep-24-2020 14:46:25 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838959
Page 159 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Oct-14-2020 11:28:54 (UTC-08:00) Pacific Time
(US & Canada)KAISER LAB
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838960
Page 160 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:33:00 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-28-2020 11:07:28 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838961
Page 161 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-29-2020 17:33:00 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-28-2020 11:07:28 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838962
Page 162 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:33:00 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-28-2020 11:07:28 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838963
Page 163 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:33:00 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-28-2020 11:07:28 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838964
Page 164 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-29-2020 17:33:00 (UTC-08:00) Pacific Time
(US & Canada)
4Sep-28-2020 11:07:28 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838965
Page 165 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormNov-04-2020 08:27:11 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-28-2020 12:51:45 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838966
Page 166 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Nov-04-2020 08:27:11 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-28-2020 12:51:45 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838967
Page 167 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Nov-04-2020 08:27:11 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-28-2020 12:51:45 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838968
Page 168 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Nov-04-2020 08:27:11 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-28-2020 12:51:45 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838969
Page 169 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Nov-04-2020 08:27:11 (UTC-08:00) Pacific Time
(US & Canada)
4Sep-28-2020 12:51:45 (UTC-08:00) Pacific Time
(US & Canada)Not Done
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0838970
Page 170 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838971
Page 171 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.aSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
1.aSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838972
Page 172 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.bSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
1.bSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838973
Page 173 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.cSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
1.cSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838974
Page 174 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.dSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
1.dSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838975
Page 175 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.eSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
1.eSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838976
Page 176 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1.fSep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
1.fSep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838977
Page 177 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838978
Page 178 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:41:43 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-24-2020 14:47:59 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838979
Page 179 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838980
Page 180 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838981
Page 181 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838982
Page 182 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838983
Page 183 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838984
Page 184 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838985
Page 185 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Sep-24-2020 14:48:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838986
Page 186 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:36:55 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-24-2020 14:49:38 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838987
Page 187 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-29-2020 17:36:55 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-24-2020 14:49:38 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838988
Page 188 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:36:55 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-24-2020 14:49:38 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838989
Page 189 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:36:55 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-24-2020 14:49:38 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838990
Page 190 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:39:46 (UTC-08:00) Pacific Time
(US & Canada)Not Done
FormSep-29-2020 17:39:16 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-24-2020 14:50:19 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838991
Page 191 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-29-2020 17:39:46 (UTC-08:00) Pacific Time
(US & Canada)Not Done
1Sep-29-2020 17:39:16 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-24-2020 14:50:19 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838992
Page 192 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:39:46 (UTC-08:00) Pacific Time
(US & Canada)Not Done
2Sep-29-2020 17:39:16 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-24-2020 14:50:19 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838993
Page 193 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:39:46 (UTC-08:00) Pacific Time
(US & Canada)Not Done
3Sep-29-2020 17:39:16 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-24-2020 14:50:19 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838994
Page 194 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-29-2020 17:39:46 (UTC-08:00) Pacific Time
(US & Canada)Not Done
4Sep-29-2020 17:39:16 (UTC-08:00) Pacific Time
(US & Canada)
4Sep-24-2020 14:50:19 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838995
Page 195 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838996
Page 196 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838997
Page 197 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838998
Page 198 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0838999
Page 199 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
4Sep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839000
Page 200 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839001
Page 201 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839002
Page 202 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839003
Page 203 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839004
Page 204 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839005
Page 205 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839006
Page 206 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839007
Page 207 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839008
Page 208 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839009
Page 209 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839010
Page 210 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839011
Page 211 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839012
Page 212 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839013
Page 213 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839014
Page 214 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839015
Page 215 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839016
Page 216 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839017
Page 217 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839018
Page 218 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839019
Page 219 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839020
Page 220 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839021
Page 221 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839022
Page 222 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839023
Page 223 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839024
Page 224 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839025
Page 225 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839026
Page 226 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839027
Page 227 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:43:12 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:17 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839028
Page 228 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
FormSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839029
Page 229 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
1Sep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839030
Page 230 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
2Sep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839031
Page 231 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
3Sep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839032
Page 232 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
4Sep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839033
Page 233 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839034
Page 234 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839035
Page 235 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839036
Page 236 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.aSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.aSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839037
Page 237 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839038
Page 238 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839039
Page 239 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839040
Page 240 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.bSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.bSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839041
Page 241 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839042
Page 242 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839043
Page 243 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839044
Page 244 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.cSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.cSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839045
Page 245 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839046
Page 246 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839047
Page 247 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839048
Page 248 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.dSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.dSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839049
Page 249 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839050
Page 250 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839051
Page 251 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839052
Page 252 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.eSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.eSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839053
Page 253 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839054
Page 254 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839055
Page 255 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839056
Page 256 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.fSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.fSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839057
Page 257 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839058
Page 258 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839059
Page 259 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839060
Page 260 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.gSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.gSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839061
Page 261 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.hSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839062
Page 262 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.hSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839063
Page 263 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.hSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839064
Page 264 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.hSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.hSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839065
Page 265 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.iSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839066
Page 266 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.iSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839067
Page 267 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.iSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839068
Page 268 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.iSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.iSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839069
Page 269 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.jSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839070
Page 270 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.jSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839071
Page 271 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.jSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839072
Page 272 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5.jSep-29-2020 17:46:34 (UTC-08:00) Pacific Time
(US & Canada)
5.jSep-24-2020 14:51:58 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao Not Done
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839073
Page 273 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-24-2020 14:52:31 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839074
Page 274 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-24-2020 14:52:31 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839075
Page 275 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aSep-24-2020 14:52:31 (UTC-08:00) Pacific Time
(US & Canada)Charlie Chao None
Not Applicable
090177e196ad2fec\Final\Final On: 01-Apr-2021 03:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839076
Page 276 of 720
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/24/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1270 Site Name: (1270) Kaiser Permanente Sacramento
Subject No: 12701057 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2.aSep-24-2020 14:52:31 (UTC-08:00) Pacific Time
(US & Canada)Charlie
…[truncated]