Document text
Clinical Study Data Reviewer’s
Guide
sBLA (12-1 5 Years of Age)
BioNTech SE and PFIZER INC.
Study C4591001
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This document is confidential Page 2 of 86 Clinical Data Reviewer’s Guide Revision history
Version Summary of Major Change(s) and Impact Version Date
1.0 First approved version of Clinical Data Reviewer’s Guide 13-Dec-2021
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Contents
Study C4591001 ................................ ................................ ................................ ......................... 1
Clinical Data Reviewer’s Guide Revision history ................................ ................................ ............. 2
1. Introduction ................................ ................................ ................................ ........................ 5
1.1 Purpose ................................ ................................ ................................ ....................... 5
1.2 Acronyms ................................ ................................ ................................ .................... 5
1.3 Study Data Standards and Dictionary Inventory ................................ ................................ .5
2. Protocol Description ................................ ................................ ................................ ............. 6
2.1 Protocol Number and Title................................ ................................ .............................. 6
2.2 Protocol Design ................................ ................................ ................................ ............ 8
2.2.1 Phase 1 ................................ ................................ ................................ ................. 9
2.2.2 Phase 2/3 ................................ ................................ ................................ ............ 10
2.3 Trial Design Datasets ................................ ................................ ................................ ... 12
2.3.1 TA - Trial Arms ................................ ................................ ................................ ... 12
2.3.2 TE - Trial Elements ................................ ................................ .............................. 13
2.3.3 TI - Trial Inclusion/Exclusion Criteria ................................ ................................ ..... 13
2.3.4 TS - Trial Summary ................................ ................................ .............................. 13
2.3.5 TV - Trial Visits ................................ ................................ ................................ ... 13
3. Subject Data Description ................................ ................................ ................................ ..... 16
3.1 Overview ................................ ................................ ................................ ................... 16
3.2 Traceability Flow Diagram ................................ ................................ ........................... 17
3.3 Annotated CRFs ................................ ................................ ................................ ......... 17
3.4 SDTM Subject Domains ................................ ................................ .............................. 19
3.4.1 AE - Adverse Events ................................ ................................ ............................. 20
3.4.2 CE - Clinical Events ................................ ................................ ............................. 21
3.4.3 CM - Concomitant Medications ................................ ................................ .............. 22
3.4.4 CO - Comments ................................ ................................ ................................ ... 23
3.4.5 DD – Death Details ................................ ................................ .............................. 23
3.4.6 DI - Device Identifiers ................................ ................................ ........................... 23
3.4.7 DM - Demographics ................................ ................................ ............................. 23
3.4.8 DS - Disposition ................................ ................................ ................................ ... 24
3.4.9 DV - Protocol Deviations ................................ ................................ ...................... 25
3.4.10 EC - Exposure as Collected ................................ ................................ .................... 25
3.4.11 EX - Exposure ................................ ................................ ................................ ..... 25
3.4.12 FACE - Findings About Events or Interventions ................................ ........................ 26
3.4.13 FAHO - Findings About Events or Interventions ................................ ....................... 27
3.4.14 HO - Healthcare Encounters ................................ ................................ ................... 27
3.4.15 IE - Inclusion/Exclusion Criteria Not Met................................ ................................ . 27
3.4.16 IS - Immunogenicity Specimen Assessment ................................ .............................. 27
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This document is confidential Page 4 of 86 3.4.17 LB - Laboratory Test Results ................................ ................................ .................. 27
3.4.18 MB - Microbiology Specimen ................................ ................................ ................ 28
3.4.19 MH - Medical History ................................ ................................ ........................... 28
3.4.20 MO - Morphology ................................ ................................ ................................ 28
3.4.21 PE - Physical Examination ................................ ................................ ..................... 28
3.4.22 PR – Procedures ................................ ................................ ................................ ... 29
3.4.23 SE - Subject Elements ................................ ................................ ........................... 29
3.4.24 SV - Subject Visits ................................ ................................ ............................... 29
3.4.25 VS - Vital Signs ................................ ................................ ................................ ... 29
4. Data Conformance Summary ................................ ................................ ............................... 31
4.1 Conformance Inputs ................................ ................................ ................................ .... 31
4.2 Issues Summary ................................ ................................ ................................ .......... 31
4.3 Additional Conformance Details ................................ ................................ .................... 74
Appendix I: Inclusion/Exclusion Criteria ................................ ................................ ...................... 75
Appendix II: Data Cutoff Algorithm in Standard Domains ................................ ............................... 83
Appendix III: FDA 2010.1 Issue Summary ................................ ................................ ................... 86
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This document is confidential Page 5 of 86 1.Introduction
1.1 Purpose
This document provides context for tabulation datasets and terminology that benefit from additional
explanation beyond the Data Definitions document (define.xml). In addition, this document provides
a summary of SDTM conformance findings.
1.2 Acronyms
Acronym Translation
AE Adverse Event
CBER Center for Biologics Evaluation and Research
COVID -19 Coronavirus Disease 2019
cSDRG Clinical Study Data Reviewer’s Guide
MedDRA Medical Dictionary for Regulatory Activities
modRNA Nucleoside -Modified Messenger Ribonucleic Acid
NAAT Nucleic Acid Amplification Test
SARS -CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2
SDTM Study Data Tabulation Model
SoA Schedule of Activities
TAUG Therapeutic Area User Guide
WOCBP Woman/Women of Childbearing Potential
1.3 Study Data Standards and Dictionary Inventory
Standard or Dictionary Versions Used
SDTM •SDTM v1.4
•SDTM -IG v3.2
Controlled Terminology CDISC SDTM Controlled Terminology, 2020 -03-27
Data Definitions Define -XML v2.0
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This document is confidential Page 6 of 86 Standard or Dictionary Versions Used
Medications Dictionary WHODD GLOBALV3Mar20, WHO DDE v202003, SNOMED
2020 -09-01, UNII 2020 -08-18, NDF -RT 2020 -09-08
Medical Events Dictionary MedDRA v23.1
2.Protocol Description
2.1 Protocol Number and Title
Protocol Number: C4591001
Protocol Short Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and
Efficacy of RNA Vaccine Candidates Against COVID -19 in Healthy Individuals.
Note: Protocol Amendment’s 13, 14 and beyond mentioned elsewhere in the submission
documentation are out of scope for this sBLA and have not been included in this cSDRG.
Protocol Versions:
Amendment 12: 2020 -01-08
•Because of a formatting error in protocol amendment 11, exclusion criterion 4 was
inadvertently added to exclusion criterion 3 and the subsequent criteria renumbered. This
amendment corrects that error.
Amendment 11: 2020 -01-04
•Added a potential intensive surveillance period for nasal swabbing, for assessment via
NAAT:
oCorresponding SoA and procedures added
Amendment 10: 2020 -12-01
•Added the possibility of administering BNT162b2 to participants who originally received
placebo, following any local or national recommendations.
•Added the possibility of administering BNT162b2 to participants who originally received
placebo, following completion of the active safety surveillance period.
Amendment 9: 2020 -10-29
•To better align with the natural history of SARS -CoV-2 infection, added Phase 2/3
secondary efficacy objectives, estimands, and endpoints to include COVID -19 cases that
occur from 14 days after the second dose; also modified the existing secondary efficacy
objectives, estimands, and endpoints to include COVID -19 cases that occur from 14 days, as
well as 7 days, after the second dose;
oMade corresponding changes to the study design, study assessments and procedures,
and statistical analysis sections.
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This document is confidential Page 7 of 86 •Clarified that interim analyses will be conducted after accrual of at least 62, 92, and 120
cases.
•Included any participants 16 through 17 years of age enrolled under this amendment in the
reactogenicity subset.
•Clarified that serology data after a postbaseline positive SARS -CoV-2 test result will not be
included in the analysis based on the evaluable immunogenicity populations.
Amendment 8: 2020 -10-15
•Clarified that for participants who are not in the reactogenicity subset, local reactions and
systemic events following vaccination should be detected and reported as AEs.
•Clarified that premenarchal females are not WOCBP.
Amendment 7: 2020 -10-06
•Reduced the lower age range to include adolescents 12 to 15 years of age and added
corresponding objectives.
•Added that 2 periods of potential COVID -19 symptoms within 4 days will be considered as a
single illness.
Amendment 6: 2020 -09-08
•Removed exclusion criterion 2 (ie, known infection with HIV, HCV, or HBV) for Phase 3
and added criteria for HIV-positive participants.
•Decreased the lower age limit and removed the upper age limit for inclusion in Phase 2/3 in
order to evaluate BNT162b2 30 μg in older adolescents and those over 85 years of age;
updated the title and other references to adults to align with this change.
•Clarified that inclusion criterion 4 (ie, participants at higher risk for acquiring COVID -19) is
applicable for Phase 2/3 only, and provided some examples
Amendment 5: 2020 -07-24
•Clarified that a single vaccine candidate, administered as 2 doses 21 days apart, will be
studied in Phase 2/3.
•Stated that the vaccine candidate selected for Phase 2/3 evaluation is BNT162b2 at a dose of
30 μg.
•Renamed Stage 1 to Phase 1, removed Stage 2, and renamed Stage 3 to Phase 2/3.
•Clarified which stopping rules apply to which phase of the study.
•Moved the immunogenicity objectives in Phase 2/3 to become exploratory.
•Modified exclusion criterion 5, so that participants with a previous clinical or
microbiological diagnosis of COVID -19 are excluded from all phases of the study.
Amendment 4: 2020 -06-30
•BNT162b3 candidate has been added to the protocol.
•Further nonclinical data are available to support the study of the BNT162b3 candidate in
humans, and the candidate has been added to the protocol.
•The 6-month safety follow -up telephone contact has been changed to an in-person visit for
Stage 3 participants, to allow collection of an immunogenicity blood sample.
Amendment 3: 2020 -06-10
•20-μg dose level is formally included for BNT162b1 and BNT162b2.
•In order to increase flexibility enrolling participants, an extended screening window
(increased from 14 to 28 days) for sentinel participants in Stage 1 has been added. This is
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stable medical conditions.
Amendment 2: 2020 -05-27
•Added a 50-μg dose level for vaccine candidates based on the modRNA platform (ie,
BNT162b1, BNT162b2, and BNT162b3).
Amendment 1: 2020 -05-13
•Decreased the dose levels for BNT162a1 and BNT162c2
•Modified exclusion criteria and prohibited inhaled/nebulized corticosteroids for sentinel
participants in Stage 1.
Original Protocol 2020 -04-15
2.2 Protocol Design
The study consists of 2 parts. This cSDRG is for subjects in all Phases. Phase 1: to identify preferred
vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. These parts,
and the progression between them, are detailed in the schema.
Phase 1 For each vaccine candidate (4:1 randomization active:placebo)
Age: 18-55 y Age: 65-85 y
Low -dose -level 2-dose group (n=15)
IRC (safety) Low -dose -level 2-dose group (n=15)
High Mid-dose -level 2-dose group
(n=15)
Mid-dose -level 2-dose group (n=15)
IRC choice of group(s) for Phase 2/3
(safety & immunogenicity after Doses 1 and 2)
Phase 2/3 Single vaccine candidate (1:1 randomization active:placebo)
Safety and immunogenicity analysis
of Phase 2 data (first 360 participants)
by unblinded team (these participants
will also be included in Phase 3
analyses) Age: ≥12
(Stratified 12-15, 16-55, or >55)
BNT162b2 30 µg or placebo 2 doses
(n~21,999 per group, total n~43.998)
Abbreviation: IRC = internal review committee. IRC (safety
after Dose 1)
IRC (safety
after Dose 1)
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This document is confidential Page 9 of 86 The study will evaluate the safety, tolerability, and immunogenicity of 2 different SARS -CoV-2 RNA
vaccine candidates against COVID -19 and the efficacy of 1 candidate:
•As a 2-dose (separated by 21 days) schedule;
•At various different dose levels in Phase 1;
•In 3 age groups: (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥ 12 years
of age [stratified as 12-15, 16-55, or >55 years of age]).
Dependent upon safety and/or immunogenicity data generated during the course of this study, or
the BioNTech study conducted in Germany (BNT162 -01), it is possible that groups in Phase 1
may be started at the next highest dose, groups may not be started, groups may be terminated
early, and/or groups may be added with dose levels below the lowest stated dose or intermediate
between the lowest and highest stated doses.
The study is observer -blinded, as the physical appearance of the investigational vaccine
candidates and the placebo may differ. The participant, investigator, study coordinator, and other
site staff will be blinded. At the study site, only the dispenser(s)/administrator(s) are unblinded.
To facilitate rapid review of data in real time, sponsor staff will be unblinded to vaccine
allocation for the participants in Phase 1.
2.2.1 Phase 1
Each group (vaccine candidate/dose level/age group) will comprise 15 participants;
12 participants will be randomized to receive active vaccine and 3 to receive placebo.
For each vaccine candidate/dose level/age group, the following apply:
•Additional safety assessments (see protocol, Section 8.2)
•Controlled enrollment (required only for the first candidate and/or dose level studied):
•No more than 5 participants (4 active, 1 placebo) can be vaccinated on the first day
•The first 5 participants must be observed by blinded site staff for at least 4 hours after
vaccination for any acute reactions
•Vaccination of the remaining participants will commence no sooner than 24 hours after
the fifth participant received his or her vaccination
•Application of stopping rules
•IRC review of safety data to determine escalation to the next dose level in the 18- to 55-year
age cohort:
•Escalation between dose levels will be based on IRC review of at least 7-day post–Dose
1 safety data in this study and/or the BioNTech study conducted in Germany (BNT162 -
01)
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This document is confidential Page 10 of 86 •Note that, since both candidates are based upon the same RNA platform, dose escalation
for the second candidate studied may be based upon the safety profile of the first
candidate studied being deemed acceptable at the same, or a higher, dose level by the
IRC
Groups of participants 65 to 85 years of age will not be started until safety data for the RNA
platform have been deemed acceptable at the same, or a higher, dose level in the 18- to 55-year
age cohort by the IRC.
In this phase, 13 groups will be studied, corresponding to a total of 195 participants.
The IRC will select 1 vaccine candidate that, in Phase 1, has an established dose level per age
group based on induction of a post–Dose 2 immune response, including neutralizing antibodies,
which is expected to be associated with protection against COVID -19, for progression into Phase
2/3.
Participants who originally received placebo and become eligible for receipt of BNT162b2 or
another COVID -19 vaccine according to local or national recommendations (detailed separately,
and available in the electronic study reference portal) will have the opportunity to receive
BNT162b2 as part of the study. The investigator will ensure the participant meets at least 1 of the
recommendation criteria. Any Phase 1 placebo recipient who has not already been offered the
opportunity to receive BNT162b2 will be given this opportunity at the approximate time
participants in Phase 2/3 reach Visit 4. Any participant who originally received placebo but then
goes on to receive BNT162b2 will move to a new visit schedule (Section 1.3.3).
2.2.2 Phase 2/3
On the basis of safety and/or immunogenicity data generated during the course of this study,
and/or the BioNTech study conducted in Germany (BNT162 -01), 1 vaccine candidate was
selected to proceed into Phase 2/3. Participants in this phase will be ≥12 years of age, stratified as
follows: 12 to 15 years, 16 to 55 years, or >55 years. The 12- to 15-year stratum will comprise up
to approximately 2000 participants enrolled at selected investigational sites. It is intended that a
minimum of 40% of participants will be in the >55-year stratum. Commencement of each age
stratum will be based upon satisfactory post–Dose 2 safety and immunogenicity data from the 18 -
to 55-year and 65- to 85-year age groups in Phase 1, respectively. The vaccine candidate selected
for Phase 2/3 evaluation is BNT162b2 at a dose of 30 μg.
Phase 2/3 is event -driven. Under the assumption of a true VE rate of ≥60%, after the second dose
of investigational product, a target of 164 primary -endpoint cases of confirmed COVID -19 due to
SARS -CoV-2 occurring at least 7 days following the second dose of the primary series of the
candidate vaccine will be sufficient to provide 90% power to conclude true VE >30% with high
probability. The total number of participants enrolled in Phase 2/3 may vary depending on the
incidence of COVID -19 at the time of the enrollment, the true underlying VE, and a potential
early stop for efficacy or futility.
Assuming a COVID -19 attack rate of 1.3% per year in the placebo group, accrual of 164 first
primary -endpoint cases within 6 months, an estimated 20% non-evaluable rate, and 1:1
randomization, the BNT162b2 vaccine candidate selected for Phase 2/3 is expected to comprise
approximately 21,999 vaccine recipients. This is the number of participants initially targeted for
Phase 2/3 and may be adjusted based on advice from DMC analyses of case accumulation and the
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This document is confidential Page 11 of 86 percentage of participants who are seropositive at baseline. Dependent upon the evolution of the
pandemic, it is possible that the COVID -19 attack rate may be much higher, in which case accrual
would be expected to be more rapid, enabling the study’s primary endpoint to be evaluated much
sooner.
The first 360 participants enrolled (180 to active vaccine and 180 to placebo, stratified equally
between 18 to 55 years and >55 to 85 years) will comprise the “Phase 2” portion. Safety data
through 7 days after Dose 2 and immunogenicity data through 1 month after Dose 2 from these
360 participants will be analyzed by the unblinded statistical team, reviewed by the DMC, and
submitted to appropriate regulatory authorities for review. Enrollment may continue during this
period and these participants would be included in the efficacy evaluation in the “Phase 3”
portion of the study.
In Phase 3, up to approximately 2000 participants, enrolled at selected sites, are anticipated to be
12 to 15 years of age. Noninferiority of immune response to prophylactic BNT162b2 in
participants 12 to 15 years of age to response in participants 16 to 25 years of age will be assessed
based on the GMR of SARS -CoV-2 neutralizing titers using a 1.5-fold margin. A sample size of
225 evaluable participants (or 280 vaccine recipients) per age group will provide a power of
90.8% to declare the noninferiority in terms of GMR (lower limit of 95% CI for GMR >0.67). A
random sample of 280 participants from each of the 2 age groups (12 to 15 years and 16 to 25
years) will be selected as an immunogenicity subset for the noninferiority assessment.
The initial BNT162b2 was manufactured using “Process 1”; however, “Process 2” was developed
to support an increased scale of manufacture. In the study, each lot of “Process 2”-manufactured
BNT162b2 will be administered to approximately 250 participants 16 to 55 years of age. The
safety and immunogenicity of prophylactic BNT162b2 in individuals 16 to 55 years of age
vaccinated with “Process 1” and each lot of “Process 2” study intervention will be described. A
random sample of 250 participants from those vaccinated with study intervention produced by
manufacturing “Process 1” will be selected for this descriptive analysis.
Participants are expected to participate for up to a maximum of approximately 26 months. The
duration of study follow -up may be shorter among participants enrolled in Phase 1 dosing arms
that are not evaluated in Phase 2/3.
The initial BNT162b2 was manufactured using “Process 1”; however, “Process 2” was developed
to support an increased scale of manufacture. In the study, each lot of “Process 2”-manufactured
BNT162b2 will be administered to approximately 250 participants 16 to 55 years of age. The
safety and immunogenicity of prophylactic BNT162b2 in individuals 16 to 55 years of age
vaccinated with “Process 1” and each lot of “Process 2” study intervention will be described. A
random sample of 250 participants from those vaccinated with study intervention produced by
manufacturing “Process 1” will be selected for this descriptive analysis.
Participants are expected to participate for up to a maximum of approximately 26 months. The
duration of study follow -up may be shorter among participants enrolled in Phase 1 dosing arms
that are not evaluated in Phase 2/3.
Participants ≥ 16 years of age who originally received placebo and become eligible for receipt of
BNT162b2 or another COVID -19 vaccine according to local or national recommendations
(detailed separately, and available in the electronic study reference portal) will have the
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meets at least 1 of the recommendation criteria.
Any Phase 2/3 placebo recipient ≥16 years of age who has not already been offered the
opportunity to receive BNT162b2 will be given this opportunity from 6 months after Vaccination
2 (at the time of the originally planned Visit 4).
Any Phase 2/3 placebo recipient ≥16 years of age who has not already been offered the
opportunity to receive BNT162b2 will be given this opportunity from 6 months after Vaccination
2 (at the time of the originally planned Visit 4).
Any participant who originally received placebo but then goes on to receive BNT162b2 will
move to a new visit schedule (Section 1.3.3).
An intensive period of surveillance to evaluate the efficacy of BNT162b2 against asymptomatic
SARS -CoV-2 infection may be conducted at selected sites among Phase 2/3 participants following
approval of protocol amendment 11. After an initial in-person visit where a blood sample
will be collected and a nasal (midturbinate) swab obtained, nasal (midturbinate) swabs
will be obtained from consented participants every 2 weeks until Visit 4, or a sufficient number of
cases of SARS -CoV-2 infection have accrued to evaluate this objective, whichever is sooner, per
the SoA. The swabs will be tested at a central laboratory using NAAT to detect SARS -CoV-2.
Participants who originally received placebo and become eligible for receipt of BNT162b2
according to local or national recommendations and then receive BNT162b2 as part of the study
will not participate in surveillance for asymptomatic SARS -CoV-2 infection; if they become
eligible during the surveillance period, the swabbing every 2 weeks will cease.
2.3 Trial Design Datasets
Are Trial Design datasets included in the submission? - Yes
Dataset Dataset Label
TA Trial Arms
TE Trial Elements
TI Trial Inclusion/Exclusion Criteria
TS Trial Summary
TV Trial Visits
2.3.1 TA - Trial Arms
For Phase 1, subjects were randomly assigned to receive either BNT162b1, BNT162b2, or placebo.
For Phase 2/3, subjects were randomly assigned to receive either BNT162b2 or placebo.
The detailed information for ARM and ARMCD was shown in the table below.
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BNT162b1 Phase 1 (10 mcg) B1_10
BNT162b1 Phase 1 (100/10 mcg) B1_100
BNT162b1 Phase 1 (20 mcg) B1_20
BNT162b1 Phase 1 (30 mcg) B1_30
BNT162b2 Phase 1 (10 mcg) B2_10
BNT162b2 Phase 1 (20 mcg) B2_20
BNT162b2 Phase 1 (30 mcg) B2_30
BNT162b2 Phase 2/3 (30 mcg) B2_P23_30
Placebo PLACEBO
2.3.2 TE - Trial Elements
There were ten trial elements in this study for Phase 1 including one screening element and eight
vaccination elements: BNT162b1 (10 mcg), BNT162b1 (20 mcg), BNT162b1 (30 mcg), BNT162b1
(100 mcg), BNT162b2 (10 mcg), BNT162b2 (20 mcg), BNT162b2 (30 mcg), and Placebo. There was
also one follow -up element.
There were 4 trial elements in this study for Phase 2/3 including one screening element and 2
vaccination elements: BNT162b2 (30 mcg) and Placebo. There was also one follow -up element.
For Placebo subject from Phase 1 that qualified to receive BNT162b2 (30 mcg), additional elements
were included: Screening Open Label & Follow -up Open Label.
2.3.3 TI - Trial Inclusion/Exclusion Criteria
See Appendix I: Inclusion/Exclusion Criteria for the complete text of each inclusion or exclusion
criteria.
2.3.4 TS - Trial Summary
The Trial Summary (TS) dataset details a summary of the trial in a structured format. Each record in
the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. Trial
Summary was used to record basic information about the study such as trial phase, protocol title, and
trial objectives, as well as, information about the planned and actual trial characteristics.
In accordance with the FDA business rule, the values for PARAMCD equal to AGEMIN,
PLANSUB, and NARMS has been combined into one record. The minimum age for Phase 1 is 18
years while Phase 2/3 is 12. The planned number of arms for Phase 1 is 7 while Phase 2/3 is 2. The
planned number of participants for Phase 1 is 195 while Phase2/3 is 21,999.
2.3.5 TV - Trial Visits
The trial visits dataset describes the planned visits of the trial and consists of 19 visits for Phase 1 and
11 visits for Phase 2/3. Each visit and visit description are shown in the table below.
Visits V4_WEEK3_VAX2_S_R; V5_WEEK1_POSTVAX2_S_R; V6_WEEK2_POSTVAX2_S_R;
V6_WEEK2_POSTVAX2_S_R; are for subjects who received 100mcg during vaccination 1 for
Phase 1. Dose of 100 mcg was deemed too high and the dosing/visit was stopped for approximately 4
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This document is confidential Page 14 of 86 months. After 4 months, the subject returned and received 10 mcg at vaccination 2 and completed the
rest of the visits.
Visits in the chart below with the suffix of “_S” and “_L” , excluding COVID visits, are related to
Phase 1 and Phase 2/3 respectively.
VISITNUM VISIT VISITDY Description
1 COVID_A COVID -19 illness onset
200 COVID_A1 After the visit of COVID -19 illness onset
2 COVID_B COVID -19 illness onset
201 COVID_B1 After the visit of COVID -19 illness onset
3 COVID_C COVID -19 illness onset
202 COVID_C1 After the visit of COVID -19 illness onset
4 COVID_D COVID -19 illness onset
203 COVID_D1 After the visit of COVID -19 illness onset
5 COVID_E COVID -19 illness onset
204 COVID_E1 After the visit of COVID -19 illness onset
6 COVID_F COVID -19 illness onset
205 COVID_F1 After the visit of COVID -19 illness onset
7 COVID_G COVID -19 illness onset
206 COVID_G1 After the visit of COVID -19 illness onset
8 COVID_H COVID -19 illness onset
207 COVID_H1 After the visit of COVID -19 illness onset
9 COVID_I COVID -19 illness onset
208 COVID_I1 After the visit of COVID -19 illness onset
10 COVID_J COVID -19 illness onset
209 COVID_J1 After the visit of COVID -19 illness onset
11 COVID_K COVID -19 illness onset
210 COVID_K1 After the visit of COVID -19 illness onset
12 COVID_L COVID -19 illness onset
211 COVID_L1 After the visit of COVID -19 illness onset
13 COVID_M COVID -19 illness onset
212 COVID_M1 After the visit of COVID -19 illness onset
14 COVID_N COVID -19 illness onset
213 COVID_N1 After the visit of COVID -19 illness onset
15 COVID_O COVID -19 illness onset
214 COVID_O1 After the visit of COVID -19 illness onset
16 COVID_P COVID -19 illness onset
215 COVID_P1 After the visit of COVID -19 illness onset
17 COVID_Q COVID -19 illness onset
216 COVID_Q1 After the visit of COVID -19 illness onset
18 COVID_R COVID -19 illness onset
217 COVID_R1 After the visit of COVID -19 illness onset
19 COVID_S COVID -19 illness onset
218 COVID_S1 After the visit of COVID -19 illness onset
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20 COVID_T COVID -19 illness onset
219 COVID_T1 After the visit of COVID -19 illness onset
60776 End of Treatment Start of end of treatment visit
60777 Follow -Up First day of follow -up visit
60772 POT_COVID_CONVA 28 to 35 days after potential COVID -19 illness visit
60771 POT_COVID_ILL Optimally within 3 days after potential COVID -19
illness onset
51231792 REVAX_CONTACT Start of contact
60747 SCR Informed consent
20210 SSWAB_WEEK10 Surveillance swab sample collection at week 10
20212 SSWAB_WEEK12 Surveillance swab sample collection at week 12
20214 SSWAB_WEEK14 Surveillance swab sample collection at week 14
20216 SSWAB_WEEK16 Surveillance swab sample collection at week 16
20218 SSWAB_WEEK18 Surveillance swab sample collection at week 18
20202 SSWAB_WEEK2 Surveillance swab sample collection at week 2
20220 SSWAB_WEEK20 Surveillance swab sample collection at week 20
20222 SSWAB_WEEK22 Surveillance swab sample collection at week 22
20224 SSWAB_WEEK24 Surveillance swab sample collection at week 13
20226 SSWAB_WEEK26 Surveillance swab sample collection at week 14
20228 SSWAB_WEEK28 Surveillance swab sample collection at week 15
20204 SSWAB_WEEK4 Surveillance swab sample collection at week 4
20206 SSWAB_WEEK6 Surveillance swab sample collection at week 6
20208 SSWAB_WEEK8 Surveillance swab sample collection at week 8
60765 V1_DAY1_VAX1_L 1 Day 1
60748 V1_DAY1_VAX1_S 1 Day 1
60757 V10_MONTH24_S 749 714 to 742 days after visit 4
51231793 V101_VAX3 Open label vaccination 1
51231794 V102_VAX4 Open label vaccination 2
51231795 V103_MONTH1 28 to 35 Days after visit 102
51231796 V104_MONTH6 175 to 189 days after visit 102
51231797 V105_MONTH18 532 to 560 days after visit 102
60749 V2_DAY2_POSTVAX1_S 2 1 to 3 days after visit 1
60766 V2_VAX2_L 21 19 to 23 days after visit 1 or 56 to 70 days after visit 1
56985855 V201_SURVEIL_CONSENT Infection Surveillance Consent
60767 V3_MONTH1_POSTVAX2_L 51 28 to 35 days after visit 2
60750 V3_WEEK1_POSTVAX1_S 7 6 to 8 days after visit 1
60768 V4_MONTH6_L 173 154 to 168 days after visit 2
60751 V4_WEEK3_VAX2_S 21 19 to 23 days after visit 1
1165454 V4_WEEK3_VAX2_S_R NA
60769 V5_MONTH12_L 371 350 to 378 days after visit 2
60752 V5_WEEK1_POSTVAX2_S 28 6 to 8 days after visit 4
1165455 V5_WEEK1_POSTVAX2_S_R 6 to 8 days after visit 4_R
60770 V6_MONTH24_L 733 714 to 742 days after visit 2
60753 V6_WEEK2_POSTVAX2_S 35 12 to 16 days after visit 4
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1165456 V6_WEEK2_POSTVAX2_S_R 12 to 16 days after visit 4_R
60754 V7_MONTH1_S 52 28 to 35 days after visit 4
1165457 V7_MONTH1_S_R 28 to 35 days after visit 4_R
60755 V8_MONTH6_S 182 154 to 168 days after visit 4
60756 V9_MONTH12_S 385 350 to 378 days after visit 4
3.Subject Data Description
3.1 Overview
Are the submitted data taken from an ongoing study? Yes
For analysis, a data cutoff of 13Mar2021 was applied on the SDTM data. Furthermore, any data
related to the booster portion of the Phase 1 subjects was also programmatically excluded from
SDTM data. Details about the cutoff algorithm applied to the SDTM data can be found in
Appendix II.
Were the SDTM datasets used as sources for the analysis datasets? Yes
Do the submission datasets include screen failures? Yes
If yes, which datasets include screen failure data?
Dataset Dataset Label
AE Adverse Events
CE Clinical Events
CM Concomitant Medications
CO Comments
DM Demographics
DS Disposition
DV Protocol Deviations
FACE Findings About Events or Interventions
HO Healthcare Encounters
IE Inclusion/Exclusion Criteria Not Met
IS Immunogenicity Specimen Assessments
LB Laboratory Test Results
MB Microbiology Specimen
MH Medical History
PE Physical Examination
SE Subject Elements
SUPPAE Supplemental Qualifiers for AE
SUPPCE Supplemental Qualifiers for CE
SUPPCM Supplemental Qualifiers for CM
SUPPDM Supplemental Qualifiers for DM
SUPPDS Supplemental Qualifiers for DS
SUPPDV Supplemental Qualifiers for DV
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SUPPHO Supplemental Qualifiers for HO
SUPPIE Supplemental Qualifiers for IE
SUPPIS Supplemental Qualifiers for IS
SUPPLB Supplemental Qualifiers for LB
SUPPMB Supplemental Qualifiers for MB
SUPPMH Supplemental Qualifiers for MH
SUPPPE Supplemental Qualifiers for PE
SV Subject Visits
VS Vital Signs
Were any domains planned, but not submitted because no data were collected? No
Are the submitted data a subset of collected data? No
Is adjudication data present? No
3.2 Traceability Flow Diagram
3.3 Annotated CRFs
Collected fields and pages that have not been tabulated have been annotated as "Not Submitted".
Pfizer collects certain data elements to facilitate operational processes including data cleaning and
dynamically creating additional forms in the electronic data capture system. All fields and pages that
have been annotated as "Not Submitted" meet this criterion and are described below.
Explanation of data fields [Not Submitted]
aCRF page
Number(s) Data Collection Field Explanation of why [NOT SUBMITTED]
24, 91, 93 1.Lowest Level Term,
2.Lowest Level Term Code,
3.High Level Term,
4.High Level Term Code,
5.High Level Group Term,Coding is done after data extraction during
SDTM mapping
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Number(s) Data Collection Field Explanation of why [NOT SUBMITTED]
6.High Level Group Term Code,
7.Primary System Organ Class
8.Primary System Organ Class
Code
14 Cohort Selection Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
35 Inform Enrollment Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
36 HIV Status Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
63 Casebook Signature Form Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
84 Further Vaccination Confirmation Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
89 Inform Screening Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
95, 96, 97 Stratification Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
98 Subject Status Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
105 Unplanned assessments Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
12, 15, 16, 24,
40, 41, 42, 70,
72, 76, 77, 82,
83, 91, 93, 106,
108, 110 Comparison Term Not needed for analysis.
15, 16, 76, 110 Concomitant Medications Pre-
specified Not needed for analysis.
33 COVID -19 Surveillance Visit Not needed for analysis.
18, 19, 20, 21 1.Follow -Up Contact Category
2.Was contact made?
3.If No, why?
4.Comments Not needed for analysis.
30, 31, 32, 33,
34 Erroneous Visit Not needed for analysis.
18, 19, 20, 21,
105 Contact Outcome Not needed for analysis.
36 Select appropriate response - What
is the subject HIV status? Not needed for analysis. The whole page is
annotated as NOT SUBMITTED.
40 1.Category of Clinical Event
2.Was a diagnosis obtained for
Potential COVID -19 Illness? (NO) Not needed for analysis.
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Number(s) Data Collection Field Explanation of why [NOT SUBMITTED]
41, 42 Was a diagnosis obtained? (NO) Not needed for analysis.
64, 65 Lab Sub-Panel Not needed for analysis.
87, 90, 100 Sample Collected? Not needed for analysis.
75, 87, 88, 90,
100 Sample ID Not needed for analysis.
81 CISR Category Not needed for analysis.
91, 93 Event Pre-specified Not needed for analysis.
102 1.Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
2.Were injection site reactions
present on the last day the Subject
Diary was completed? Not needed for analysis.
108 Container Number Not needed for analysis.
3.4 SDTM Subject Domains
Dataset - Dataset Label Efficacy Safety Other SUPP -- Related Using
RELREC
AE - Adverse Events X X DS, CE
CE - Clinical Events X X AE, FACE,
VS
CM - Concomitant
Medications X X
CO - Comments X
DD – Death Details X
DI - Device Identifiers X MB, LB
DM - Demographics X X
DS - Disposition X X AE
DV - Protocol Deviations X X
EC - Exposure as Collected X X
EX - Exposure X X
FACE - Findings About
Events or Interventions X X CE
FAHO - Findings About
Events or Interventions X HO
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RELREC
HO - Healthcare Encounters X X FAHO
IE - Inclusion/Exclusion
Criteria Not Met X X
IS - Immunogenicity
Specimen Assessment X X
LB - Laboratory Test Results X X DI
MB - Microbiology Specimen X X DI
MH - Medical History X X
MO - Morphology X X
PE - Physical Examination X X
PR - Procedures X X
SE - Subject Elements X
SV - Subject Visits X
VS - Vital Signs X X CE
3.4.1 AE - Adverse Events
Adverse events dataset consists of one record per adverse event per subject.
The entry of a “Y” for the serious adverse event variable, AESER, indicates the AE meets the criteria
as serious per investigator report and the definition in the CRF guidance.
Adverse events, medication errors, newly diagnosed chronic medical conditions and reactogenicity
are included in the AE dataset and distinguished by AECAT. To implement the CDISC Vaccines
TAUG flat model, records of reactogenicity are added to AE domain from CE with AECAT=
“REACTOGENICITY”, when the duration of reactogenicity events go beyond the planned
observation period. AECAT = ”AEMERES ” represents AE as a result of a study medication error
collected in SUPPAE.
A relationship has been defined in RELREC between the disposition event where DSDECOD=
ADVERSE EVENT or DEATH and the adverse event leading to discontinuation. The observations
are related by AESEQ and DSSEQ. A relationship has also been defined between the adverse events
and clinical event summary records and are related by AELNKGRP and CELNKGRP.
QNAM Description
AEAENO Associated Adverse Event Identifier
AECMGIV Concomitant Medication Given
AEMEFL Medication Error Associated With
AE
AEMERES Is AE a Result of a Medication
Error
AEMOD Updated with unsolicited AE data
AENDGIV Was a Non-Drug Treatment given
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AERELTXT Event Due to Other Specify
AESUBJDC Discontinued because of this AE
DICTVER Dictionary Name and Version
3.4.2 CE - Clinical Events
Clinical Events dataset consists of one record per event per subject.
Clinical Events implements Vaccines TAUG flat model for reactogenicity records, where it
summarizes each symptom event per vaccination per subject. CECAT = “REACTOGENICITY”.
The corresponding daily assessments from the e-diary are in FACE.
Unplanned assessments occurring during the diary period will be utilized along with the e-diary data
in creating the summary records in CE, even if the assessment was not required per protocol (no
symptom reported or symptom was reported but not severe). The worst reported severity will be
mapped for each symptom in the summary record and stop date will reflect the latest symptom date
from the e-diary or unplanned assessment, or from Symptom Resolved Dates form if continued past
the diary period.
Reactogenicity exclusions are as follows:
•If subject is not part of reactogenicity subset but has unplanned reactogenicity assessments
(unplanned temp or unplanned assessment of local reactio n/systemic event), or has
unplanned assessments without any diary data, then these unplanned assessments were
dropped from FACE/VS and summary CE records were not generated.
•If an unplanned assessment exists with an assessment date (CEDTC) falling after the stop
date recorded on the Symptom Resolved Dates CRF, these records were dropped from FACE
for that visit. Only data up through the stop date from Symptom Resolved Dates in the CRF
were used to create the CE records.
•If a subject has diary data and their symptom did not occur during the diary period but was
on the unplanned assessment after diary period, then the unplanned assessment was dropped
(symptom must begin during diary period to be part of reactogenicity).
•If there were unplanned assessments after the diary period and the Symptom Resolved Dates
form was present but did not have a stop date or 'ongoing' recorded for that symptom, then
the unplanned assessments were dropped.
Potential COVID -19 illness from the ILLNESS DETAILS - POTENTIAL COVID -19
ILLNESS CRF is included with CECAT = “EFFICACY”. The investigator’s diagnosis is in
CETERM. Subjects who progress to severe disease, as defined in the protocol, will have data entered
on the ILLNESS DETAILS - SEVERE COVID -19 ILLNESS CRF which is reported in the CE
domain with CECAT = ‘SEVERE COVID -19 ILLNESS’ and CESCAT (Subcategory) denoting
whether there was significant acute renal, hepatic, or neurologic dysfunction.
As agreed with CBER, CE includes event records for “COVID -19 like illness” and “COVID -19
confirmed” in the CE domain for subjects who were assigned to a vaccination arm (DM.ARM is not
“SCREEN FAILURE” or “NOT ASSIGNED”) as follows:
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(CDECASE) in SUPPDM.
•“COVID -19 like illness” is flagged “Y” when a subject has at least one pre-specified
symptom. Please note that a subject may have more than one occurrence of “COVID -19 like
illness” if symptoms presented during different illness visits, but only has one record for
“COVID -19 confirmed” that has a visit associated when the case was assessed to be positive.
•When there is confirmed COVID -19, the assessment of each pre-specified symptom
corresponding to that symptomatic period (i.e., corresponding COVID Illness visit) will
additionally be included in the CE domain, with CESCAT = “SIGNS AND SYMPTOMS OF
DISEASE” .
•As start and stop dates were not collected for each symptom individually, CESTDTC and
CEENDTC was not populated for each symptom but the date first symptom started and date
last symptom resolved was mapped to CESTDTC and CEENDTC in the “COVID -19 like
illness” and “COVID -19 confirmed” records.
•The individual symptoms have VISIT and collection date (CEDTC) populated from the
relevant COVID Illness visit.
•Toxicity grade for a COVID -19 like illness is collected in the ILLNESS DETAILS -
POTENTIAL COVID -19 ILLNESS CRF so CETOXGR is populated instead of CESEV in
the “COVID -19 like illness” and “COVID -19 confirmed” records. It is not collected for each
symptom individually.
•For COVID illness, CRF will collect toxicity grade as 0 for asymptomatic subjects. If an
illness visit is performed for asymptomatic participant, toxicity grade will be reported as "0"
while the participant is asymptomatic. If participant later experiences symptoms, the
appropriate toxicity grade will be updated.
A relationship has been defined in RELREC been defined between the adverse events and clinical
event summary records and are related by AELNKGRP and CELNKGRP. A relationship has also
been defined between clinical event summary records and findings about records. The observations
are related by CELNKGRP and FALNKGRP. A relationship has also been defined between clinical
event summary records and temperature vital signs records using CELNKGRP and VSLNKGRP.
QNAM Description
CEDRVFL Derived Flag
CEEVAL Evaluator
DICTVER Dictionary Name and Version
ONGNXVIS Reported Ongoing at Next Visit
RCENDTC Reported Clinical Event End Date
QNAM = “CEDRVFL” is used to indicate that an entire record is derived.
3.4.3 CM - Concomitant Medications
Concomitant Medications dataset consists of one record per recorded medication occurrence or
constant -dosing interval per subject.
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CMCLAS1 Medication Class 1
CMCLAS2 Medication Class 2
CMCLSCD1 Medication Class Code 1
CMCLSCD2 Medication Class Code 2
CMCODE Standardized Medication Code
DICTVER Dictionary Name and Version
3.4.4 CO - Comments
Comments dataset consists of one record per comment per subject.
3.4.5 DD – Death Details
Death details dataset consists of one record per finding per subject, for primary and any secondary
causes of death.
3.4.6 DI - Device Identifiers
Device identifiers dataset consists of one record per device identifier per device.
A relationship has been defined in RELREC between the device identifier records and the
corresponding laboratory and microbiology records. The observations are related by SPDEVID.
3.4.7 DM - Demographics
Demographics dataset consists of one record per subject.
Specify Other Race and Ethnicity have been submitted in SUPPDM.
The following subject issues were observed in this dataset (analysis rules for these subjects are
described in the Analysis Data Reviewers Guide):
•The following subjects were enrolled into the study more than once.
Duplicated
Subject # SUBJID at 1st Site SUBJID at 2nd site
1 10561101 11331382
2 11101123 11331405
3 11491117 12691090
4 12691070 11351357
5 11341006 10891112
6 11231105 10711213
.
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This document is confidential Page 24 of 86 •Subjects C4591001 1081 10811053, C4591001 1088 10881077, C4591001 1177 11771089 and
C4591001 1231 12311057 received an additional dose at an unscheduled visit after receiving one
dose of [BNT162b2 (30 mcg)] and one dose of placebo.
•Subjects C4591001 1080 10801222 and C4591001 1149 11491108 have values of NOT
ASSIGNED for randomized group due to the randomization number not entered on the CRF.
Both subjects withdrew from the study prior to administration of study drug.
Split Sites:
Pfizer created multiple virtual site ID’s and spread the enrollment across these virtual site ID’s despite it
being a single physical site with a single office and a single investigator. See example below. The
SITEID will be the original SITEID (1231) and the USUBJID will reflect the new virtual site (e.g., 4444,
5555) used for analysis.
QNAM Description
CDECASE Clinical disease endpoint case flag
RACE1 Race1
RACE2 Race2
RACE3 Race3
RACE4 Race4
As agreed with CBER, CDECASE qualifier in SUPPDM is populated for each subject from the ADaM
primary endpoint case flag for the first primary efficacy endpoint, as defined in the protocol. This flag is
derived based on ADSL and ADC19EF ADaM datasets.
3.4.8 DS - Disposition
Disposition dataset consists of one record per disposition status or protocol milestone per
subject.
If Participants terminated early, the appropriate reason for discontinuation as per protocol are
recorded in the End of Treatment (EOT) and Follow -up (FUP) visit Disposition pages.
DSPHASE in SUPPDS corresponds to the pages and can be used to link the records with
multiple disposition per EPOCH.
A relationship has been defined in RELREC between the disposition event where DSDECOD=
ADVERSE EVENT or DEATH and the adverse event leading to discontinuation. The observations
are related by AESEQ and DSSEQ.
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DSPHASE Disposition Phase
DSRANGRP Randomization Group
3.4.9 DV - Protocol Deviations
Protocol Deviations dataset consists of one record per protocol deviation per subject
QNAM Description
ACTSITE Actual Site of Deviation Occurrence
CAPE Confirmed Analysis Population Exclusion
DESGTOR Visit Designator
DVTERM1 Protocol Deviation Term 1
SOURCE Source of the data
3.4.10 EC - Exposure as Collected
Exposure as collected dataset consists of one record per protocol -specified study treatment,
collected -dosing interval, per subject, per mood.
QNAM Description
ECADJ1 Reason for Dose Adjustment 1
ECADJ2 Reason for Dose Adjustment 2
ECCD Standardized Medication Code
ECDECOD Standardized Medication Name
ECDOSADJ Dose Adjusted From Planned
ECDOSAJO Reason Dose Adjusted Other Specify
ECOBSV Observed Post Dose For Specified Time
ECOBSVD Details Of Subject Observation
ECOBSVT Timeframe Subject Was Observed
ECTDV Temporary Delay of Vaccination
FDDTC Date of First Delay
3.4.11 EX - Exposure
Exposure dataset consists of one record per constant dosing interval per subject.
•A third exposure record will exist in the domain for C4591001 1231 12311057 and C4591001 1177
11771089 due to the subjects receiving an additional dose at an unscheduled visit.
•Participants ≥ 16 years of age who originally received placebo and became eligible for receipt of
BNT162b2 or another COVID -19 vaccine will have additional vaccination records.
•For subjects with temporary delay of vaccination without treatment information and vaccination
date, data will not be used or retained in SDTM.
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EXADJ1 Reason for Dose Adjustment 1
EXADJ2 Reason for Dose Adjustment 2
EXCD Standardized Medication Code
EXDECOD Standardized Medication Name
EXDOSADJ Dose Adjusted From Planned
EXDOSAJO Reason Dose Adjusted Other Specify
EXOBSV Observed Post Dose For Specified Time
EXOBSVD Details Of Subject Observation
EXOBSVT Timeframe Subject Was Observed
EXTDV Temporary Delay of Vaccination
FDDTC Date of First Delay
3.4.12 FACE - Findings About Events or Interventions
Findings About dataset consists of one record per finding per object per time point per time point
reference per visit per subject.
FACE implements flat model for reactogenicity records, including e-diary and unplanned
assessments of reactogenicity findings. Unplanned assessments are under FACAT =
“REACTOGENICITY - UNPLANNED ASSESSMENT ” while diary data has FACAT =
“REACTOGENICITY”. FASTAT = “NOT DONE” records are generated for any missed diary
days and are flagged with FADRVFL = “Y”.
Subjects not part of reactogenicity subset should not have any e-diary data, unplanned assessments or
Symptom Resolved Dates form completed.
a.Programming does not generate any ‘NOT DONE’ records for these subjects. Any e-
diary and Symptom Resolved Dates CRF data that was completed is dropped if subject is
not part of reactogenicity subset.
b.Unplanned assessments without an e-diary will be dropped from reactogenicity datasets
and would be counted only as an adverse event or COVID -19 symptom in the relevant
domain.
Signs and symptoms of COVID -19 are included with FACAT = “EFFICACY”.
A relationship has been defined in RELREC between clinical event summary records and findings
about records. The observations are related by CELNKGRP and FALNKGRP.
QNAM Description
CLTYP Collection Type
FALANG Language Version of Instrument
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Findings About dataset consists of one record per finding per object per time point per time point
reference per visit per subject.
A relationship has been defined in RELREC been defined between healthcare encounter events and
the corresponding findings about event records. The observations are related by HOLNKID and
FALNKID.
3.4.14 HO - Healthcare Encounters
Healthcare Encounters dataset consists of one record per healthcare encounter per subject.
A relationship has been defined in RELREC been defined between healthcare encounter events and
the corresponding findings about event records. The observations are related by HOLNKID and
FALNKID.
QNAM Description
HCUHSP Hospitalized due to COVID -19 illness?
HCUICU Been in ICU due to COVID -19 illness?
HCUIDIS Disease Name
3.4.15 IE - Inclusion/Exclusion Criteria Not Met
Inclusion/Exclusion Criteria Not Met dataset consists of one record per inclusion/exclusion criterion
not met per subject.
QNAM Description
IEDESC Details
3.4.16 IS - Immunogenicity Specimen Assessment
Immunogenicity Specimen Assessment dataset consists of one record per test per visit per subject.
QNAM Description
ETRKDOR Data Origin
3.4.17 LB - Laboratory Test Results
Laboratory Test Results dataset consists of one record per analyte per planned time point number per
time point reference per visit per subject.
A relationship has been defined in RELREC between the device identifier records and the
corresponding laboratory records. The observations are related by SPDEVID.
QNAM Description
LBSCATYN Lab Sub-Panel Collected
LBSTTYPE Standardized Unit
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LBTSTID Laboratory Test Identifier
LBUID Lab ID
LBUNEVFL Not Evaluable Flag
3.4.18 MB - Microbiology Specimen
Microbiology Specimen dataset consists of one record per microbiology specimen finding per time
point per visit per subject.
SARS -CoV-2 test results from local labs will have MBCAT = “CONFIRMATION OF
INFECTION” (as collected in the CRF) and central labs have MBCAT = “VIROLOGY”.
A relationship has been defined in RELREC between the device identifier records and the
corresponding microbiology records. The observations are related by SPDEVID.
QNAM Description
ETRKDOR Data Origin
MBSCATYN Lab Sub-Panel Collected
MBSTTYPE Standardized Unit
MBTSTID Laboratory Test Identifier
MBUID Lab ID
TRADEOTH Other Trade Name
3.4.19 MH - Medical History
Medical History dataset consists of one record per medical history event per subject.
QNAM Description
DICTVER Dictionary Name and Version
3.4.20 MO - Morphology
Morphology dataset consists of one record per Morphology finding per location per time point per
visit per subject.
QNAM Description
ASPECIFY Overall Assessment Detail
LOCOTH Location of Assessment Detail
METHOTH Imaging Method Other Detail
3.4.21 PE - Physical Examination
Physical Examination dataset consists of one record per body system or abnormality, per visit, per
subject.
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PECLSIG Clinically Significant Findings
3.4.22 PR – Procedures
Subject Procedures dataset consists of one record per recorded procedure per occurrence per subject.
QNAM Description
DICTVER Dictionary Name and Version
PRBDSYCD Body System or Organ Class Code
PRBODSYS Body System or Organ Class
PRHLGT High Level Group Term
PRHLGTCD High Level Group Term Code
PRHLT High Level Term
PRHLTCD High Level Term Code
PRLLT Lowest Level Term
PRLLTCD Lowest Level Term Code
PRPTCD Preferred Term Code
PRSOC Primary System Organ Class
PRSOCCD Primary System Organ Class Code
3.4.23 SE - Subject Elements
Subject Elements dataset consists of one record per actual element per subject.
3.4.24 SV - Subject Visits
Subject Visits dataset consists of one record per actual visit per subject.
3.4.25 VS - Vital Signs
Vital Signs dataset consists of one record per vital sign measurement per time point per visit per
subject.
To implement the CDISC Vaccines TAUG flat model, temperature records from e-diary are
mapped to VS domain with VSCAT = “REACTOGENICITY” . Any unplanned temperature
assessments by the investigator post vaccination are included with VSCAT =
“REACTOGENICITY - UNPLANNED TEMPERATURE ”. VSSTAT = “NOT DONE” records
are generated for any missed diary days and are flagged with VSDRVFL = “Y”.
Non-reactogenicity vital signs have VSCAT = “GENERAL VITAL SIGNS”.
A relationship has also been defined between clinical event summary records and temperature vital
signs records using CELNKGRP and VSLNKGRP.
QNAM Description
CLTYP Collection Type
VSCOLSRT Collected Summary Result Type
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“CRF” if recorded by the investigator.
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4.1 Conformance Inputs
Was a validator used to evaluate conformance? Yes
If yes, specify the version(s) of the validation rules: Pinnacle 21 Enterprise version 4.1.4
Validation Engine version 1907.2
Were sponsor -defined validation rules used to evaluate conformance? No
Were the SDTM datasets evaluated in relation to define.xml? Yes
Was define.xml evaluated? Yes
Provide any additional compliance evaluation information:
Pinnacle Validation Engine FDA 2010.1 was also used to evaluate the data. See Appendix III for key issues using v2010.1.
4.2 Issues Summary
Check
ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0080 AE start date is after the latest
Disposition date Error AE 4558
(11.54%) At the time of data extraction, study is still
ongoing and disposition status is collected at the
completion or discontinuation of each stage of the
study therefore may not have occurred at the time
of this data snapshot.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0091 AEOUT is not 'FATAL', when
AESDTH='Y' Error AE 3 (5.88%) Subject C4591001 1135 11351033 - official death
certificate and autopsy results are pending so the
cause of death can be updated. Query is present to
track the issue.
Subject C4591001 1088 10881126 - Primary
cause of death is already reported as Cardiac
Arrest, there is a blank extra log line on the form
that has already been queried to be deleted.
SD1202 AESTDTC date is after
RFPENDTC Error AE 367
(1.32%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1204 AEENDTC date is after
RFPENDTC Error AE 477
(1.85%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD2010 Value for AEHLT not found in
MedDRA dictionary Error AE 1 (< 0.1%) Manual coding done on the day of snapshot due to
a leading space in the Verbatim Term which
prevented auto coding. Once the update is done by
site to the Verbatim Term this will be resolved.
SD2012 Value for AEHLGT not found in
MedDRA dictionary Error AE 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
TS0012 Analysis Required variable AESEV
not found Error AE 1
(100.00%) AESEV not collected in the CRF for the study.
AETOXGR (Toxicity Grade) variable used for
severity.
TS0053 Neither AESEV or AETOXGR is
populated Error AE 2627
(6.65%) Reactogenicity events that are present after the
diary period were added to AE domain and
severity or toxicity grades were not captured after
end of diary period. Refer to Appendix 3 for more
details on roadmap for mapping of reactogenicity
data.
SD1076 Model permissible variable added
into standard domain Notice AE 5
(18.52%) Model permissible variables were added to the
domain CE for the study protocol needs:
AELNKGRP
AELAT
AETPTREF
AERFTDTC
AEELTM
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning AE 25248
(63.92%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD0021 Missing End Time -Point value Warning AE 3 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0022 Missing Start Time -Point value Warning AE 1 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1021 Unexpected character value in
AEHLGT variable Warning AE 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
SD1097 No Treatment Emergent info for
Adverse Event Warning AE 39501
(100.00%) In Vaccine studies Treatment Emergent flag is not
required per communication from CBER/OVRR.
SD1143 No Details info for AESMIE
Adverse Event in SUPPAE domain Warning AE 199
(100.00%) Description of Other Medically Important Serious
Adverse Events are not collected on the CRF.
Therefore, AESOSP information is not mapped to
SUPPAE.
SD1201 Duplicate records in AE domain Warning AE 5 (< 0.1%) There are no exacted duplicate records. AESPID
values for these records are unique that
differentiates the records.
SD1333 AEOUT =
RECOVERED/RESOLVED, but
an end date is not provided Warning AE 1 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0005 Duplicate value for CESEQ
variable Error CE 1 (< 0.1%) This is a false positive by P21 and is part of a
known issue for SD0005 -- rule logic is flagging
falsely (per P21 support).
The team confirmed that there is only one record
with USUBJID='C4591001 1231 12315324' and
CESEQ=460000000004 in CE domain.
SD0041 Value for CEOCCUR is populated
for unsolicited Intervention or
Event Error CE 94560
(97.38%) At the request of CBER, records with
CETERM=COVID -19 like illness and COVID -19
have been added for all subjects, with CEOCCUR
= Y or N. These are considered derived records
rather than spontaneous.
(References: IND 19736.92).
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1082 Variable length is too long for
actual data Error CE 1 (2.94%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for SUPPQUAL
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1202 CESTDTC date is after
RFPENDTC Error CE 10 (<
0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1203 CEDTC date is after RFPENDTC Error CE 11 (<
0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1204 CEENDTC date is after
RFPENDTC Error CE 113
(0.25%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1331 CESTDTC is after CEDTC Error CE 10 (<
0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD2012 Value for CEHLGT not found in
MedDRA dictionary Error CE 1 (< 0.1%) Manually coded as "Virus infectious disorders".
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1076 Model permissible variable added
into standard domain Notice CE 22
(56.41%) Model permissible variables were added to the
domain CE for the study protocol needs:
•CERFTDTC
•CEHLGTCD
•CELLTCD
•CELAT
•CEEVINTX
•CEDUR
•CEBDSYCD
•CESOCCD
•CELNKGRP
•VISITNUM
•CEHLGT
•CEHLTCD
•CETOXGR
•CEPTCD
•CETPTNUM
•CESOC
•CEHLT
•VISIT
•CETPT
•CELOC
•CETPTREF
•CELLT
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning CE 50541
(13.33%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD0021 Missing End Time -Point value Warning CE 5155
(1.36%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0022 Missing Start Time -Point value Warning CE 5156
(1.36%) The CESTDTC is missing for
CECAT='REACTOGENICITY' where when
CEOCCUR='N' and is as per the CBER/OVRR
flat model implementation.
For CECAT='EFFICACY', CESTDTC is not
collected on the CRF "Illness details " page.
SD0031 Missing values for CESTDTC,
CESTRF and CESTRTPT, when
CEENDTC, CEENRF or
CEENRTPT is provided Warning CE 1 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning CE 10 (<
0.1%) This rule fired for subjects who had missing visits
in SV domain. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
SD1201 Duplicate records in CE domain Warning CE 100952
(26.63%) CETPTREF is different for all specified
CETERMs either VACCINATION 1 or
VACCINATION 2. Therefore, these records are
not true duplicates.
SD1339 Missing EPOCH value, when a
start or observation date is provided Warning CE 11809
(17.33%) For events domains --STDTC is used to derive
EPOCH. Since CESTDTC is missing for these
records, EPOCH is not derived.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0035 Missing value for CMDOSU, when
CMDOSE, CMDOSTXT or
CMDOSTOT is provided Error CM 153
(25.89%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
SD1202 CMSTDTC date is after
RFPENDTC Error CM 34
(0.59%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1204 CMENDTC date is after
RFPENDTC Error CM 3
(10.34%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1344 Value for CMDECOD not found in
WHODrug dictionary Error CM 528
(6.61%) Pfizer internal dictionary version (202003) was
customized to add these terms from a newer
dictionary, however these are not present in
WHODRUG 202003.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning CM 4456
(55.80%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD0021 Missing End Time -Point value Warning CM 7917
(99.15%) End date was not collected for SCR visit
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0022 Missing Start Time -Point value Warning CM 4 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0077 Invalid referenced record Error CO 2 (< 0.1%) For two records we have comments entered in
CO, they are unrelated any specific domain.
Subject C4591001 1170 11701321 test results
were discarded by accident.
Subject C4591001 1055 10551150 have no test
results
Therefore, we have records in CO but not present
in MB domain.
SD1082 Variable length is too long for
actual data Error CO 3
(30.00%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1203 CODTC date is after RFPENDTC Error CO 9 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1076 Model permissible variable added
into standard domain Notice CO 2 (8.00%) Model permissible variables were added to the
domain CE for the study protocol needs:
VISIT
VISITNUM
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning CO 194
(0.14%) This rule fired for records coming from comments
captured related to Immunogenicity data which
was not used to derive SV.
SD0002 NULL value in DDTESTCD
variable marked as Required Error DD 2 (4.17%) Subject C4591001 1135 11351033 - official death
certificate and autopsy results are awaited so that
cause of death can be updated. Query is present to
track the issue.
subject C4591001 1088 10881126 - Primary cause
of death is already reported as Cardiac Arrest,
there is a blank extra log line on the form that has
already been queried to be deleted.
SD0002 NULL value in DDTEST variable
marked as Required Error DD 2 (4.17%) Subject C4591001 1135 11351033 - official death
certificate and autopsy results are awaited so that
cause of death can be updated. Query is present to
track the issue.
subject C4591001 1088 10881126 - Primary cause
of death is already reported as Cardiac Arrest,
there is a blank extra log line on the form that has
already been queried to be deleted.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1203 DDDTC date is after RFPENDTC Error DD 23
(47.92%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1076 Model permissible variable added
into standard domain Notice DD 1 (1.43%) Model permissible variable was added to the
domain DD for the study protocol needs:
•DDCAT
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning DD 14
(29.17%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
SD0047 Missing value for DDORRES,
when DDSTAT or DDDRVFL is
not populated Warning DD 2
(100.00%) Subject C4591001 1135 11351033 - official death
certificate and autopsy results are pending so that
cause of death can be updated. Query is present to
track the issue.
subject C4591001 1088 10881126 - Primary cause
of death is already reported as Cardiac Arrest,
there is a blank extra log line on the form that has
already been queried to be deleted.
SD1117 Duplicate records Warning DD 1 (2.17%) Not a true duplicate, subject C4591001 1094
10941112 has two secondary causes of death
"COVID -19 Infection" and "Pneumonia".
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1320 Missing value for DDSTRESC,
when DDSTAT is null Warning DD 2 (4.17%) Subject C4591001 1135 11351033 - official death
certificate and autopsy results are pending so that
cause of death can be updated. Query is present to
track the issue.
subject C4591001 1088 10881126 - Primary cause
of death is already reported as Cardiac Arrest,
there is a blank extra log line on the form that has
already been queried to be deleted.
DD0050 Domain/SASDatasetName
mismatch for split dataset Error DEFINE 1
(100.00%) Per SDTM IG v3.2, sponsors may choose to split
a domain of topically related information into
physically separate datasets. Currently our
internal approach is to split FA by topic hence we
have dataset with names FACE, SUPPFACE,
FAHO.
SD0002 NULL value in SPDEVID variable
marked as Required Error DI 3 (3.80%) This rule fired for 3 records in DI domain where
SPDEVID was null. At the time of data extraction
study is still ongoing and complete SPDEVID
data was not obtained at the time of the snapshot.
SD1234 Missing TYPE Parameter for
Device Error DI 39
(100.00%) Device Type Parameter information is not
available for the Medical Device used in the
study.
SD2003 Invalid value for ACTARM Error DM 160
(0.34%) Screen failures have ACTARM='NOT
ASSIGNED' instead of propcase 'Not Assigned'.
TS0006 No Baseline (ALT) test results for
Subject Error DM 46329
(99.58%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
TS0007 No Baseline (ALP) test results for
Subject Error DM 46329
(99.58%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0008 No Baseline (AST) test results for
Subject Error DM 46329
(99.58%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0009 No Baseline (BILI) test results for
Subject Error DM 46329
(99.58%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0023 No (WEIGHT) results for subject Error DM 2 (< 0.1%) This rule fired for 2 subjects who had no
WEIGHT in VS dataset. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
USUBJID = C4591001 1161 11611005 and
C4591001 1161 11611018
TS0024 No (HEIGHT) results for subject Error DM 2 (< 0.1%) This rule fired for 2 subjects who had no HEIGHT
in VS dataset. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
USUBJID = C4591001 1161 11611005 and
C4591001 1161 11611018
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
TS0039 No (ALT) test results Error DM 45949
(98.76%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0040 No (ALP) test results Error DM 45950
(98.77%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0041 No (AST) test results Error DM 45950
(98.77%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0042 No (BILI) test results Error DM 45948
(98.76%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0047 No (SYSBP) test results for subject Error DM 45149
(97.04%) Per protocol blood pressure is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
TS0048 No (DIABP) test results for subject Error DM 45149
(97.04%) Per protocol blood pressure is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which would be during study
conduct and will not be used to set the baseline
flag.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
TS0049 No (HR) or (PULSE) test results
for subject Error DM 45149
(97.04%) Per protocol heart rate or pulse are not collected
for Phase 2/3. Lab data could be collected for
COVID illness visits, which would be during
study conduct and will not be used to set the
baseline flag.
TS0043 No (GGT) test results Notice DM 46524
(100.00%) Per protocol GGT( Gamma -Glutamyl Transferase)
is not collected.
CT2002 RACE value not found in 'Race'
extensible codelist Warning DM 1166
(2.42%) New terms were added to extensible codelist
RACE (C74457) for the study protocol needs:
•MULTIPLE
Multiple RACE values collected for few subjects.
Therefore, RACE value set as 'MULTIPLE' in
DM and all the collected RACE values mapped to
SUPPDM.
SD0006 No baseline flag record in MB for
subject Warning DM 107
(0.23%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which are during study conduct and
will not be used to set the baseline flag.
SD0006 No baseline flag record in VS for
subject Warning DM 2 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
SD0006 No baseline flag record in LB for
subject Warning DM 32928
(70.78%) Per protocol safety lab data is not collected for
Phase 2/3. Lab data could be collected for COVID
illness visits, which are during study conduct and
will not be used to set the baseline flag.
SD1032 No records for 'SCRNFAIL' subject
are found in IE domain Warning DM 1 (< 0.1%) Subject C4591001 1162 11621371 was a screen
failure due to subject meeting delayed criteria,
and not Inclusion/Exclusion related.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1258 RFSTDTC is populated for subject
who did not receive treatment Warning DM 112
(7.15%) There were 112 subjects that were randomized but
not treated. Therefore, RFSTDTC was populated
for those records when ACTARM was 'Not
Treated'. the actual dosing start date RFXSTDTC
is not populated
SD1334 RFICDTC is after RFSTDTC Warning DM 1 (< 0.1%) Subject C4591001 1161 11611011 did not sign
informed consent at visit1 (01AUG2020). Site
had subject come in to sign consent on
19AUG2020.
SD1335 RFICDTC is after RFXSTDTC Warning DM 1 (< 0.1%) Subject C4591001 1161 11611011 did not sign
informed consent at visit1 (01AUG2020). Site
had subject come in to sign consent on
19AUG2020.
SD2236 ACTARMCD does not equal
ARMCD Warning DM 120
(0.25%) There were 120 subjects in the analysis with
treatment errors: 112 subjects were not treated; 8
subjects received the wrong treatment instead of
their randomized treatment
SD2237 ACTARM does not equal ARM Warning DM 120
(0.25%) There were 120 subjects in the analysis with
treatment errors: 112 subjects were not treated; 8
subjects received the wrong treatment instead of
their randomized treatment.
SD0002 NULL value in DSDECOD
variable marked as Required Error DS 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release
SD0002 NULL value in DSTERM variable
marked as Required Error DS 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1319 DSSTDTC is before RFICDTC Error DS 2 (< 0.1%) Subject C4591001 1161 11611011 did not sign
informed consent at visit1 (01AUG2020). Site
had subject come in to sign consent on
19AUG2020.
SD1331 DSSTDTC is after DSDTC Error DS 520
(0.38%) There were labs that the site had to wait for to
assess screen failure status, it is expected that the
SF date would be after the SCR DOV.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning DS 66212
(23.34%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
CT2005 DSDECOD value not found in
'Completion/Reason for Non-
Completion' extensible codelist
when DSCAT == 'DISPOSITION
EVENT' Warning DS 210
(0.17%) New terms were added to extensible codelist
Completion/Reason for Non-Completion
(C66727) for the study protocol needs:
•NO LONGER MEETS ELIGIBILITY
CRITERIA
•REFUSED FURTHER STUDY PROCEDURES
•MEDICATION ERROR WITHOUT
ASSOCIATED ADVERSE EVENT
SD1201 Duplicate records in DS domain Warning DS 438
(0.15%) The values of DSPHASE in SUPPDS are
generated from two different CRF pages
("VACCINATION" "FOLLOW -UP"); However,
these appear to be true duplicates in DS due to
same information being entered on both CRFs.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1318 No records for subject are found in
DV domain Warning DS 1 (0.27%) Study was ongoing at the time of the data
extraction therefore DV data is not complete and
reconciled for all subjects at that time (record
missing for subjects C4591001 1084 10841290).
Dataset will be updated and reconciled for final
deliverables at time of study completion.
SD1202 DVSTDTC date is after
RFPENDTC Error DV 185
(0.66%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1319 DVSTDTC is before RFICDTC Error DV 4347
(11.71%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning DV 22665
(61.07%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD1201 Duplicate records in DV domain Warning DV 823
(2.22%) DVSPID values are unique for these records.
Therefore, these are not true duplicates.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1082 Variable length is too long for
actual data Error EC 1 (5.00%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1202 ECSTDTC date is after
RFPENDTC Error EC 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1204 ECENDTC date is after
RFPENDTC Error EC 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1282 ECTPTREF variable is present
when ECELTM, ECTPTNUM, and
ECTPT are missing Error EC 1
(100.00%) Based on CDISC TAUG, ECTPTREF can be
populated for Vaccine studies; ECELTM,
ECTPTNUM, and ECTPT are not necessary .
SD1076 Model permissible variable added
into standard domain Notice EC 2 (9.09%) Model permissible variables were added to the
domain CE for the study protocol needs:
VISIT
VISITNUM
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning EC 92370
(72.08%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
SD1082 Variable length is too long for
actual data Error EX 1 (5.26%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1202 EXSTDTC date is after
RFPENDTC Error EX 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1204 EXENDTC date is after
RFPENDTC Error EX 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1282 EXTPTREF variable is present
when EXELTM, EXTPTNUM, and
EXTPT are missing Error EX 1
(100.00%) Based on CDISC TAUG, ECTPTREF can be
populated for Vaccine studies; ECELTM,
ECTPTNUM, and ECTPT are not necessary.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1076 Model permissible variable added
into standard domain Notice EX 2 (6.90%) Model permissible variables were added to the
domain CE for the study protocol needs:
VISIT
VISITNUM
CT2002 EXDOSU value not found in 'Unit'
extensible codelist Warning EX 127736
(99.70%) New terms were added to extensible codelist Unit
(C71620) for the study protocol needs:
•mcg
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning EX 92370
(72.09%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
SD0082 Exposure end date is after the latest
Disposition date Warning EX 8857
(6.91%) At the time of data extraction, study is still
ongoing and disposition status is collected at the
completion or discontinuation of each stage of the
study therefore may not have occurred at the time
of this data snapshot.
SD1340 EX record is present, when subject
is not treated Warning EX 3 (< 0.1%) This check fired for 3 subjects, all randomized
and not treated due to medication error without
associated adverse event (2 active, 1 placebo).
USUBJID in (C4591001 1163 11631005,
C4591001 1163 11631006, C4591001 1163
11631008)
SD1203 FADTC date is after RFPENDTC Error FA 271 (<
0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD2239 Inconsistent value for FATPT Error FA 3347
(0.16%) Values are populated correctly as per Vaccine
TAUG. P21 rule is expecting same
TPT/TPTNUM used across subject/DTC. Since
DTC differs, P21 check fired, however there is an
inherent assumption in the rule that for different
times on same date, the timepoint should be
different (e.g. 1 HR and 3 HRS timepoints cannot
have same date/time values), which does not
apply here.
SD1076 Model permissible variable added
into standard domain Notice FA 12
(22.64%) Model permissible variables were added to the
domain FA for the study protocol needs:
•FATPTNUM
•FADRVFL
•FAEVLINT
•FATPTREF
•FAENRTPT
•FALNKID
•FAEVINTX
•FARFTDTC
•FALNKGRP
•FAENTPT
•FATPT
•FAREFID
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning FA 2045291
(95.49%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
CT2002 FASTRESU value not found in
'Unit' extensible codelist Warning FA 3817
(0.18%) New term was added to extensible codelist Unit
(C71620) for the study protocol needs:
•VISITS/CONTACTS
CT2002 FAORRESU value not found in
'Unit' extensible codelist Warning FA 10814
(0.50%) New terms were added to extensible codelist Unit
(C71620) for the study protocol needs:
•CALIPER UNIT
•VISITS/CONTACTS
SD0016 Missing value for FASTRESC,
when FADRVFL='Y' Warning FA 226050
(95.35%) As per CBER guidance, the records were derived
for missed diary days and FADRVFL flag is used
to indicate that data was not collected.
SD0026 Missing value for FAORRESU,
when FAORRES is provided Warning FA 1 (< 0.1%) Result collected is a date which has no associated
units.
SD0029 Missing value for FASTRESU,
when FASTRESC is provided Warning FA 1 (< 0.1%) Result collected is a date which has no associated
units.
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning FA 1 (< 0.1%) This rule fired for subjects who had missing visits
in SV domain. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
SD1021 Unexpected character value in
FAOBJ variable Warning FA 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release. Query in place to update the
data.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1117 Duplicate records Warning FA 19 (<
0.1%) The FAOBJ which appears to be duplicate for
records, which are not pre-specified for collection
on the CRF, however the verbatim term is unique
for these records and are coded to same preferred
term.
SD1122 Missing value for FASTRESN Warning FA 1 (< 0.1%) FASTRESC is a date and has no associated units.
SD1124 Missing value for FAREASND,
when FASTAT is 'NOT DONE' Warning FA 173 (<
0.1%) Reason for NOT DONE not collected on the CRF.
TS0050 Missing PC dataset Warning GLOBAL 1
(100.00%) Not applicable for this study
TS0051 Missing PP dataset Warning GLOBAL 1
(100.00%) Not applicable for this study
SD1082 Variable length is too long for
actual data Error HO 1 (5.56%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for SUPPQUAL
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1202 HOSTDTC date is after
RFPENDTC Error HO 1 (1.09%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1204 HOENDTC date is after
RFPENDTC Error HO 3 (3.57%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1076 Model permissible variable added
into standard domain Notice HO 4
(14.81%) Model permissible variables were added to the
domain CE for the study protocol needs:
VISIT
VISITNUM
HOEVINTX
HOLNKID
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning HO 27042
(42.07%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD0021 Missing End Time -Point value Warning HO 3817
(5.94%) For 3331 records Start and End dates are missing
as they are not collected on the HEALTHCARE
UTILIZATION ASSESSMENT CRF.
SD0022 Missing Start Time -Point value Warning HO 3817
(5.94%) HOSTDTC is missing as start date is not collected
on the source CRF - HEALTHCARE
UTILIZATION ASSESSMENT.
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning HO 5 (< 0.1%) This rule fired for subjects who had missing visits
in SV domain. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1021 Unexpected character value in
HOTERM variable Warning HO 1 (< 0.1%) At the time of data extraction study is still ongoing
and complete data was not obtained at database
release. Query in place to update the data
SD1201 Duplicate records in HO domain Warning HO 9661
(15.03%) There are no exact duplicate records. At least one
variable value used in KEY variables: STUDYID
USUBJID HOCAT HOTERM VISITNUM
HOSTDTC differentiates the records.
SD1274 HOTERM equals 'OTHER' Warning HO 10166
(15.82%) As per the CRF 'OTHER' is collected in the study.
SD1339 Missing EPOCH value, when a
start or observation date is provided Warning HO 144
(0.22%) For HO domain --DTC is used to derive EPOCH.
Since HODTC is missing for these records,
EPOCH is not derived.
SD1082 Variable length is too long for
actual data Error IE 1 (8.33%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning IE 15
(1.00%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•REPEAT SCREENING 1
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1203 ISDTC date is after RFPENDTC Error IS 2 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1076 Model permissible variable added
into standard domain Notice IS 1 (2.56%) Model permissible variable was added to the
domain IS for the study protocol needs:
•ISTSTDTL
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning IS 4637
(4.15%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
CT2002 ISORRESU value not found in
'Unit' extensible codelist Warning IS 111616
(100.00%) New terms were added to extensible codelist Unit
(C71620) for the study protocol needs:
•NA
•UML
•NONE
SD0029 Missing value for ISSTRESU,
when ISSTRESC is provided Warning IS 5623
(75.88%) This rule fired for Immunogenicity tests for "N-
binding antibody", "SARS -CoV-2 serum
neutralizing titer 50”, "SARS -CoV-2 serum
neutralizing titer 90". Original units for these tests
was "NA" hence there's no standard units
populated.
SD1117 Duplicate records Warning IS 356
(0.32%) Not true duplicates, repeat tests are indicated by
ISTSTDTL variable in IS
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0005 Duplicate value for LBSEQ
variable Error LB 30766
(99.33%) This is a false positive by P21 and is part of a
known issue for SD0005 -- rule logic is flagging
falsely (per P21 support).
LBSEQ values are unique for each record within
LB domain and within each Unique Subject
Identifier (USUBJID), Sponsor Device Identifier
(SPDEVID) variables value.
SD0007 Inconsistent value for Standard
Units Error LB 362
(1.18%) This check fired for several lab tests with
inconsistencies in standard units.
As a standard course of action, laboratory unit
inconsistencies are reviewed by the clinical team.
At the time of data extraction, study is still
ongoing and disposition status is collected at the
completion or discontinuation of each stage of the
study therefore may not have occurred at the time
of this data snapshot.
SD1082 Variable length is too long for
actual data Error LB 1 (3.85%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1203 LBDTC date is after RFPENDTC Error LB 201
(0.37%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1076 Model permissible variable added
into standard domain Notice LB 1 (2.78%) Model permissible variable was added to the
domain MB for the study protocol needs:
•SPDEVID
CT2002 LBORRESU value not found in
'Unit' extensible codelist Warning LB 12963
(16.14%) New terms were added to extensible codelist Unit
(C71620) for the study protocol needs:
•10^3/uL
•x10^6/uL
•10^3/uL
•10^3/mm3
•/mL
•/uL
•10^6/cu mm
CT2002 LBTESTCD value not found in
'Laboratory Test Code' extensible
codelist Warning LB 1074
(1.34%) New term was added to extensible codelist
Laboratory Test Code (C65047) for the study
protocol needs:
•HIVR_US
•HYSLAW
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning LB 32460
(40.41%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
CT2002 LBSTRESU value not found in
'Unit' extensible codelist Warning LB 297
(0.37%) New terms were added to extensible codelist Unit
(C71620) for the study protocol needs:
•10^3/uL
•/mL
•10^3/mm3
•/uL
•10^6/cu mm
CT2002 LBTEST value not found in
'Laboratory Test Name' extensible
codelist Warning LB 1074
(1.34%) New term was added to extensible codelist
Laboratory Test Name (C67154) for the study
protocol needs:
•HIV RNA (Ultrasensitive)
•Hys Law Criteria
SD0026 Missing value for LBORRESU,
when LBORRES is provided Warning LB 72
(0.24%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0029 Missing value for LBSTRESU,
when LBSTRESC is provided Warning LB 72
(0.24%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning LB 15 (<
0.1%) This rule fired for subjects who had missing visits
in SV domain. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1124 Missing value for LBREASND,
when LBSTAT is 'NOT DONE' Warning LB 12187
(99.75%) Reason for NOT DONE is not collected on the
CRF Signs and Symptoms form or raw data for
COVID illness visits.
TS0057 LBSTRESN is populated but
LBSTNRHI is not populated Warning LB 303
(1.00%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
is not obtained at database release; Some normal
ranges have not been entered.
SD0005 Duplicate value for MBSEQ
variable Error MB 6686
(98.82%) This is a false positive by P21. It is not an issue
with MBSEQ but is an issue with not having a
unique record for USUBJID and SPDEVID -- rule
logic is flagging falsely (per P21 support).
MBSEQ values are unique for each record within
MB domain and within each Unique Subject
Identifier (USUBJID), Sponsor Device Identifier
(SPDEVID) variables value.
SD1082 Variable length is too long for
actual data Error MB 2 (8.33%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1203 MBDTC date is after RFPENDTC Error MB 100
(0.11%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1076 Model permissible variable added
into standard domain Notice MB 1 (2.50%) Model permissible variable was added to the
domain MB for the study protocol needs:
•SPDEVID
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning MB 59913
(45.69%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
CT2002 MBSPEC value not found in
'Specimen Type' extensible codelist Warning MB 123851
(94.44%) New terms were added to extensible codelist
Specimen Type (C78734) for the study protocol
needs:
•NASAL_SWAB
•NASAL_SWAB_SELF
•RESPIRATORY SECRETIONS
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning MB 13 (<
0.1%) This rule fired for subjects who had missing visits
in SV domain. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
SD1023 VISIT/VISITNUM values do not
match TV domain data Warning MB 73 (<
0.1%) These records having VISIT=COVID_A,
COVID_AR1, COVID_B, COVID_BR1,
COVID_C, COVID_D,
POT_COVID_REPEAT_SWAB are illness visits
and considered unplanned and not included in the
TV domain.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1082 Variable length is too long for
actual data Error MH 2
(10.53%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1144 MHSTDTC date is after RFSTDTC Error MH 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
SD1204 MHENDTC date is after
RFPENDTC Error MH 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1331 MHSTDTC is after MHDTC Error MH 3 (< 0.1%) As per the protocol, AEs that occurred prior to
dosing were collected on the Medical History
CRF. Therefore, for some records MHSTDTC is
greater than MHDTC.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1076 Model permissible variable added
into standard domain Notice MH 12
(28.57%) Model permissible variables were added to the
domain MH for the study protocol needs:
•VISIT
•MHSOCCD
•MHSOC
•MHBDSYCD
•VISITNUM
•MHLLTCD
•MHHLT
•MHHLGT
•MHLLT
•MHHLGTCD
•MHPTCD
•MHHLTCD
SD0021 Missing End Time -Point value Warning MH 9 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0022 Missing Start Time -Point value Warning MH 29 (<
0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD0031 Missing values for MHSTDTC,
MHSTRF and MHSTRTPT, when
MHENDTC, MHENRF or
MHENRTPT is provided Warning MH 21 (<
0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1201 Duplicate records in MH domain Warning MH 112 (<
0.1%) There are no exact duplicate records. At least one
variable value used in KEY variables: STUDYID
USUBJID MHCAT MHTERM MHDTC
MHSPID MHENRTPT differentiates the records.
SD1082 Variable length is too long for
actual data Error MO 1 (6.67%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
SD1203 MODTC date is after RFPENDTC Error MO 4 (1.88%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning MO 147
(43.36%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
CT2002 MOMETHOD value not found in
'Method' extensible codelist Warning MO 15
(4.42%) New term was added to extensible codelist
Method (C85492) for the study protocol needs:
•OTHER
CT2002 MOLOC value not found in
'Anatomical Location' extensible
codelist Warning MO 50
(14.75%) New term was added to extensible codelist
Anatomical Location (C74456) for the study
protocol needs:
•OTHER
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0065 USUBJID/VISIT/VISITNUM
values do not match SV domain
data Warning MO 1 (0.31%) This rule fired for subjects who had missing visits
in SV domain. At the time of data extraction study
is still ongoing and complete data was not
obtained at database release.
SD1117 Duplicate records Warning MO 6 (1.77%) Not true duplicate. Domain is unique based on
USUBJID, MOTESTCD, MOLOC,
MOMETHOD, MODTC and values of
SUPPMO.QNAM=METHOTH.
SD1082 Variable length is too long for
actual data Error PE 1 (8.33%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning PE 8680
(51.67%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
SD1082 Variable length is too long for
actual data Error PR 1 (6.25%) According to FDA technical conformance guide
section 3.3.3: The allotted length for each column
containing character (text) data should be set to
the maximum length of the variable used across
all datasets in the study except for suppqual
datasets. Pinnacle 21 provides false positive
information since it only checks the length of the
variable within the data set.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1204 PRENDTC date is after
RFPENDTC Error PR 1 (5.56%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1331 PRSTDTC is after PRDTC Error PR 20
(57.14%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD1076 Model permissible variable added
into standard domain Notice PR 1 (3.85%) Model permissible variable was added to the
domain PR for the study protocol needs:
•PRDTC
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning PR 18
(31.03%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•REPEAT SCREENING 1
SD0021 Missing End Time -Point value Warning PR 19
(32.76%) End date is not collected for the records with
PRCAT=TRANSFUSION DETAILS, these are
from the Transfusion CRF page where only the
date of transfusion is collected.
For other records with missing end date, data is
reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD0072 Invalid RDOMAIN Error RELREC 3819
(48.86%) As per SDTM IG 3.2 section 4.1.1.7 Splitting
Domains: "In RELREC, if a dataset level
relationship is defined for a split Findings About
domain, then RDOMAIN may contain the four-
character dataset name".
P21 doesn't recognize FACE or FAHO as valid
RDOMAINS.
SD0013 SESTDTC is after SEENDTC Error SE 3 (< 0.1%) Subject C4591001 1161 11611011 did not sign
informed consent at visit1 (01AUG2020). The site
had the subject come in to sign consent on
19AUG2020.
For subjects C4591001 1044 10441163,
C4591001 1232 12321112
SEENDTC=max(rfendtc, rfpendtc), which is the
last available dosing date after cutoff of 13-
March -2021, as a result SESTDTC is greater than
SEENDTC.
SD1202 SESTDTC date is after
RFPENDTC Error SE 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1204 SEENDTC date is after
RFPENDTC Error SE 2 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning SE 73526
(39.31%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD1202 SVSTDTC date is after
RFPENDTC Error SV 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1204 SVENDTC date is after
RFPENDTC Error SV 1 (< 0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD1076 Model permissible variable added
into standard domain Notice SV 1 (5.88%) Model permissible variable was added to the
domain SV for the study protocol needs:
•SVREFID
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning SV 159295
(59.86%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD1060 Duplicate VISITNUM Warning SV 3 (< 0.1%) Subject C4591001 1013 10131294 had two
records for VISIT=200 but with different visit
date. This has been queried for data issue by data
management.
Subjects C4591001 1091 10911387 and
C4591001 1241 12411482 appear to be
duplicates, however SVREFID makes them
unique.
Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning TA 12
(38.71%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD2243 Invalid TSVCDREF value for
PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment, PCLAS
is not available in NDF -RT. TSVAL is set to
"Vaccines, Nucleic Acid" from CSP dictionary,
CUI number "C0600412" is used in TSVALCD,
and "CSP" is used in TSVCDREF.
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD2260 Invalid TSVAL value for TRT Error TS 2
(100.00%) Due to the novel nature of the treatment, there is
no standard name for BNT162b1/BNT162b2 from
FDA substance registration system.
SD2261 Invalid TSVALCD value for TRT Error TS 2
(100.00%) There is no corresponding code for
BNT162b1/BNT162b2 from UNII
SD2263 Invalid TSVAL value for PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment, NDF -RT
TSVAL is set to "Vaccines, Nucleic Acid" from
CSP dictionary. And CUI number "C0600412" is
used in TSVALCD.
SD2264 Invalid TSVALCD value for
PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment, PCLAS
is not available in NDF -RT. TSVAL is set to
"Vaccines, Nucleic Acid" from CSP dictionary.
And CUI number "C0600412" is used in
TSVALCD.
SD2265 TSVAL/TSVALCD value
mismatch for PCLAS Error TS 1
(100.00%) Due to the novel nature of the treatment,
TSPARMCD=PCLAS is not available in NDF -
RT. TSVAL is set to "Vaccines, Nucleic Acid"
from CSP dictionary. And CUI number
"C0600412" is used in TSVALCD.
SD1076 Model permissible variable added
into standard domain Notice TS 1
(10.00%) Model permissible variable was added to the
domain TS to accommodate the character length
greater than 200:
•TSVAL1
CT2005 TSVAL value not found in 'Trial
Blinding Schema Response'
extensible codelist when
TSPARMCD == 'TBLIND' Warning TS 1
(100.00%) New term was added to extensible codelist
TBLIND (C66735) for the study protocol needs:
•OBSERVER BLIND
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2005 TSVAL value not found in 'Trial
Phase Response' extensible codelist
when TSPARMCD == 'TPHASE' Warning TS 1
(100.00%) New term was added to extensible codelist
TPHASE (C66737) for the study protocol needs:
•PHASE I/II/III TRIAL
SD1203 VSDTC date is after RFPENDTC Error VS 81 (<
0.1%) At the time of data extraction, study is still
ongoing and RFPENDTC is derived as the
maximum of date of disposition, Subject Visits,
date of death. Therefore, for ongoing subjects may
not yet include completion date of the current
study phase where individual dates from that
phase may already be reported.
SD2239 Inconsistent value for VSTPT Error VS 6132
(1.46%) Values are populated correctly as per Vaccine
TAUG. P21 rule is expecting same
TPT/TPTNUM used across subject/DTC. Since
DTC differs, P21 check fired, however there is an
inherent assumption in the rule that for different
times on same date, the timepoint should be
different (e.g. 1 HR and 3 HRS timepoints cannot
have same date/time values), which does not
apply here.
SD1076 Model permissible variable added
into standard domain Notice VS 6
(13.64%) Model permissible variables were added to the
domain VS for the study protocol needs:
•VSEVINTX
•VSLNKGRP
•VSEVLINT
•VSLNKID
•VSREFID
•VSEVAL
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ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
CT2002 EPOCH value not found in 'Epoch'
extensible codelist Warning VS 410819
(98.01%) New term was added to extensible codelist
EPOCH (C99079) for the study protocol needs:
•VACCINATION
•OPEN LABEL FOLLOW -UP
•REPEAT SCREENING 1
SD0016 Missing value for VSSTRESC,
when VSDRVFL='Y' Warning VS 22605
(100.00%) As per CBER guidance, the records were derived
for missed diary days and VSDRVFL flag is used
to indicate that data was not collected.
SD0027 Missing value for VSORRES,
when VSORRESU is provided Warning VS 1 (< 0.1%) At the time of data extraction study is still
ongoing and complete data was not obtained at
database release.
SD0030 Missing value for VSSTRESC,
when VSSTRESU is provided Warning VS 1 (< 0.1%) Data is reported as collected. At the time of data
extraction study is still ongoing and complete data
was not obtained at database release.
SD1117 Duplicate records Warning VS 1 (< 0.1%) Data reported as collected. These visits were
unplanned COVID illness visits
(VISIT=COVID_A) and the VSORRES values
differ for these records.
SD1124 Missing value for VSREASND,
when VSSTAT is 'NOT DONE' Warning VS 271
(1.18%) Reason for NOT DONE was not collected.
4.3 Additional Conformance Details
There are no additional details to be documented.
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Protocol/
Amendment
Version Category IETESTCD Full Text of Criterion
1.0 INCLUSION IN01A00 Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
6.0 INCLUSION IN01A05 Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study phase)
7.0 INCLUSION IN01A06 Male or female participants between the ages of 18 and 55 years, inclusive, and
65 and 85 years, inclusive (Phase 1), or >= 16 years (Phase 2/3), at
randomization
8.0 INCLUSION IN01A07 Male or female participants between the ages of 18 and 55 years, inclusive, and
65 and 85 years, inclusive (Phase 1), or >=12 years (Phase 2/3), at
randomization. Note that participants <18 years of age cannot be enrolled in the
EU
1.0 INCLUSION IN02A00 Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
1.0 INCLUSION IN03A00 Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study. Note: Healthy participants with preexisting stable disease, defined
as disease not requiring significant change in therapy or hospitalization for
worsening disease during the 6 weeks before enrollment, can be included
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Protocol/
Amendment
Version Category IETESTCD Full Text of Criterion
6.0 INCLUSION IN03A05 Healthy participants who are determined by medical history, physical
examination (if required), and clinical judgment of the investigator to be eligible
for inclusion in the study. Note: Healthy participants with preexisting stable
disease, defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 6 weeks before enrollment, can
be included
7.0 INCLUSION IN03A06 Healthy participants who are determined by medical history, physical
examination (if required), and clinical judgment of the investigator to be eligible
for inclusion in the study.
Note: Healthy participants with preexisting stable disease, defined as disease not
requiring significant change in therapy or hospitalization for worsening disease
during the 6 weeks before enrollment, can be included. Specific criteria for Phase
3 participants with known stable infection with human immunodeficiency virus
(HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) can be found in
Section 10.8
1.0 INCLUSION IN04A00 Capable of giving personal signed informed consent as described in Appendix 1,
which includes compliance with the requirements and restrictions listed in the
ICD and in this protocol
8.0 INCLUSION IN04A07 Capable of giving personal signed informed consent/have parent(s)/legal
guardian capable of giving signed informed consent as described in Appendix 1,
which includes compliance with the requirements and restrictions listed in the
ICD and in this protocol
6.0 INCLUSION IN05A05 Participants who, in the judgment of the investigator, are at risk for acquiring
COVID -19
7.0 INCLUSION IN05A06 Phase 2/3 only: Participants who, in the judgment of the investigator, are at
higher risk for acquiring COVID -19 (including, but not limited to, use of mass
transportation, relevant demographics, front line essential workers and others)
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Protocol/
Amendment
Version Category IETESTCD Full Text of Criterion
1.0 EXCLUSION EX01A00 Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality that may increase the
risk of study participation or, in the investigator's judgment, make the participant
inappropriate for the study
1.0 EXCLUSION EX02A00 Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
7.0 EXCLUSION EX02A06 Phase 1 & 2 only: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
1.0 EXCLUSION EX03A00 History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
1.0 EXCLUSION EX04A00 Receipt of medications intended to prevent COVID 19
1.0 EXCLUSION EX05A00 Stages 1 and 2 only: Previous clinical or microbiological diagnosis of COVID -
19
6.0 EXCLUSION EX05A05 Previous clinical or microbiological diagnosis of COVID -19
8.0 EXCLUSION EX05A07 Previous clinical (based on COVID -19 symptoms/signs alone, if a SARS -CoV-2
NAAT result was not available) or microbiological (based on COVID -19
symptoms/signs and a positive SARS -CoV-2 NAAT result) diagnosis of
COVID -19
1.0 EXCLUSION EX06A00 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID -
19, including those with any of the following risk factors: Hypertension, Diabetes
mellitus, Chronic pulmonary disease, Asthma, Current vaping or smoking,
History of chronic smoking within the prior year, BMI >30 kg/m2, Anticipating
the need for immunosuppressive treatment within the next 6 months
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Amendment
Version Category IETESTCD Full Text of Criterion
2.0 EXCLUSION EX06A01 Sentinel participants in Stage 1 only: Individuals at high risk for severe COVID -
19, including those with any of the following risk factors: Hypertension, Diabetes
mellitus, Chronic pulmonary disease, Asthma, Current vaping or smoking,
History of chronic smoking within the prior year, Chronic liver disease, Stage 3
or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m2),
Resident in a long-term facility, BMI >30 kg/m2, Anticipating the need for
immunosuppressive treatment within the next 6 months
6.0 EXCLUSION EX06A05 Phase 1 only: Individuals at high risk for severe COVID -19,including those with
any of the following risk factors: Hypertension, Diabetes mellitus, Chronic
pulmonary disease, Asthma, Current vaping or smoking, History of chronic
smoking within the prior year, Chronic liver disease, Stage 3 or worse chronic
kidney disease (glomerular filtration rate <60 mL/min/1.73 m2), Resident in a
long-term facility, BMI >30 kg/m2, Anticipating the need for
immunosuppressive treatment within the next 6 months
1.0 EXCLUSION EX07A00 Sentinel participants in Stage 1 only: Individuals currently working in
occupations with high risk of exposure to SARS -CoV-2 (eg, healthcare worker,
emergency response personnel)
6.0 EXCLUSION EX07A05 Phase 1 only: Individuals currently working in occupations with high risk of
exposure to SARS -CoV-2 (eg, healthcare worker, emergency response
personnel)
1.0 EXCLUSION EX08A00 Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination.
1.0 EXCLUSION EX09A00 Individuals with a history of autoimmune disease or an active autoimmune
disease requiring therapeutic intervention including but not limited to: systemic
or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis,
Guillain -Barre syndrome, multiple sclerosis, Sjogren's syndrome, idiopathic
thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant
cell arteritis (temporal arteritis), psoriasis, and insulin -dependent diabetes
mellitus (type 1)
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Protocol/
Amendment
Version Category IETESTCD Full Text of Criterion
5.0 EXCLUSION EX09A04 Sentinel participants in Stage 1 only: Individuals with a history of autoimmune
disease or an active autoimmune disease requiring therapeutic intervention,
including but not limited to: systemic or cutaneous lupus erythematosus,
autoimmune arthritis/rheumatoid arthritis, Guillain -Barre syndrome, multiple
sclerosis, Sjogren's syndrome, idiopathic thrombocytopenia purpura,
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal
arteritis), psoriasis, and insulin -dependent diabetes mellitus (type 1)
6.0 EXCLUSION EX09A05 Phase 1 only: Individuals with a history of autoimmune disease or an active
autoimmune disease requiring therapeutic intervention, including but not limited
to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid
arthritis, Guillain -Barre syndrome, multiple sclerosis, Sjogren's syndrome,
idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune
thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin -
dependent diabetes mellitus (type 1)
1.0 EXCLUSION EX10A00 Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
1.0 EXCLUSION EX11A00 Women who are pregnant or breastfeeding
1.0 EXCLUSION EX12A00 Previous vaccination with any coronavirus vaccine
1.0 EXCLUSION EX13A00 Individuals who receive treatment with immunosuppressive therapy, including
cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune
disease, or planned receipt throughout the study. If systemic corticosteroids have
been administered short term (<14 days) for treatment of an acute illness,
participants should not be enrolled into the study until corticosteroid therapy has
been discontinued for at least 28 days before study intervention administration.
Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
corticosteroids are permitted
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2.0 EXCLUSION EX13A01 Individuals who receive treatment with immunosuppressive therapy, including
cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune
disease, or planned receipt throughout the study. If systemic corticosteroids have
been administered short term (<14 days) for treatment of an acute illness,
participants should not be enrolled into the study until corticosteroid therapy has
been discontinued for at least 28 days before study intervention administration.
Inhaled/nebulized (except for sentinel subjects in Stage 1 – see exclusion 14),
intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted
1.0 EXCLUSION EX14A00 Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
1.0 EXCLUSION EX15A00 Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
1.0 EXCLUSION EX16A00 Previous participation in other studies involving study intervention containing
lipid nanoparticles
1.0 EXCLUSION EX17A00 Sentinel participants in Stage 1 only: Positive serological test for SARS -CoV-2
IgM and/or IgG antibodies at the screening visit
6.0 EXCLUSION EX17A05 Phase 1 only: Positive serological test for SARS -CoV-2 IgM and/or IgG
antibodies at the screening visit
1.0 EXCLUSION EX18A00 Sentinel participants in Stage 1 only: Any screening hematology and/or blood
chemistry laboratory value that meets the definition of a >=Grade 1 abnormality.
Note: With the exception of bilirubin, participants with any stable Grade 1
abnormalities (according to the toxicity grading scale) may be considered eligible
at the discretion of the investigator. (Note: A "stable" Grade 1 laboratory
abnormality is defined as a report of Grade 1 on an initial blood sample that
remains <=Grade 1 upon repeat testing on a second sample from the same
participant)
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6.0 EXCLUSION EX18A05 Phase 1 only: Any screening hematology and/or blood chemistry laboratory value
that meets the definition of a >= Grade 1 abnormality Note: With the exception of
bilirubin, participants with any stable Grade 1 abnormalities (according to the
toxicity grading scale) may be considered eligible at the discretion of the
investigator. (Note: A "stable" Grade 1 laboratory abnormality is defined as a
report of Grade 1 on an initial blood sample that remains <= Grade 1 upon repeat
testing on a second sample from the same participant.)
1.0 EXCLUSION EX19A00 Sentinel participants in Stage 1 only: Positive test for HIV, hepatitis B surface
antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus
antibodies (HCV Abs) at the screening visit
6.0 EXCLUSION EX19A05 Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg),
hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs)
at the screening visit
1.0 EXCLUSION EX20A00 Sentinel participants in Stage 1 only: SARS -CoV-2 NAAT -positive nasal swab
within 24 hours before receipt of study intervention
6.0 EXCLUSION EX20A05 Phase 1 only: SARS -CoV-2 NAAT -positive nasal swab within 24 hours before
receipt of study intervention
1.0 EXCLUSION EX21A00 Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
7.0 EXCLUSION EX21A06 Investigator site staff or Pfizer/BioNTech employees directly involved in the
conduct of the study, site staff otherwise supervised by the investigator, and their
respective family members
2.0 EXCLUSION EX22A01 Sentinel participants in Stage 1 only: Regular receipt of inhaled/nebulized
corticosteroids.
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6.0 EXCLUSION EX22A05 Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids
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Records are included in SDTM datasets as specified below with &cutoff equal to 13 March 2021
SDTM Domain Cutoff Description
AE
Apply util_partial_datetime_imputation.sas to AESTDTC and
AEENDTC to derive ASTDT AND AENDT respectively.
%util_partial_datetime_imputation(
_isodate =AESTDTC/AEENDTC
,_impdate = ASTDT/AENDT
,_impdateflag = %str(ASTDTF/AENDTF)
,_imputation_rule_date = %str(START/STOP));
All records with ASTDT <= &cutoff are included.
In addition,
If .<ASTDT <= &cutoff and AEENDT > cutoff date, then
- AEENDTC and AEENDY is set to missing
- AEENRTPT = ‘ONGOING’
- AEENTPT = ‘Last Subject Encounter’
- AEOUT = ‘NOT RECOVERED/NOT RESOLVED’
- AESDTH = ‘N’
end;
else if AESTDTC = ‘ ‘ and AEENDTC ne ‘ ‘and AENDT <= &cutoff
then the record is included.
If AESTDTC and AEENDTC are both missing, then the record is
included.
DROP ASTDT and AENDT
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DM Include all records with DMDTC <= &cutoff
If RFPENDTC > &cutoff then RFPENDT C = ‘ ‘
If RFSTDTC > &cutoff then do;
If randomization date > &cutoff then do;
RFSTDTC =' '; RFENDTC=' '; RFXSTDTC=' '; RFXENDTC=' ';
arm='NOT ASSIGNED'; armcd='NOTASSGN';
end;
else if randomization date <= &cutoff then do;
set RFSTDTC = randomization date;
RFENDTC=randomization date; RFXSTDTC=' ';
RFXENDTC=' ';
end;
Else if RFSTDTC <= &cutoff then do;
If RFENDTC > &cutoff then set RFENDTC=&cutoff;
RFXENDTC=&cutoff;
If DTHDTC > &cutoff then do;
set DTHDTC = ‘ ‘;
set DTHFL = ‘ ‘;
end;
EC Include all records with ECSTDTC <= &cutoff
If ECENDTC > &cutoff then do; ECENDTC = &cutoff; ECENDY =
ECENDTC – RFSTDTC +1; end;
EX Include all records with EXSTDTC <= &cutoff
If EXENDTC > &cutoff then do; EXENDTC = &cutoff; EXENDY =
EXENDTC – RFSTDTC +1; end;
DD/CE/DV/FACE/FAHO/HO/IE/IS/LB/MB/MO/PE/PR/SV/VS/SE Include all records with ( DDDTC/ CEDTC/ DVSTDTC/ (Datepart)
FADTC /HODTC/ IEDTC/ ISDTC/ (datepart) LBDTC/ MBDTC/
MODTC/ PEDTC/ PRSTDTC/ SVSTDTC/ VSDTC/ SESTDTC) <=
&cutoff
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This document is confidential Page 85 of 86 SDTM Domain Cutoff Description
DS/MH Include all records with DSDTC <= &cutoff and ( DSSTDTC/
MHSTDTC) <= &cutoff
CM
Apply util_partial_datetime_imputation.sas to CMSTDTC and
CMENDTC to derive ASTDT AND AENDT respectively.
%util_partial_datetime_imputation(
_isodate =CMSTDTC/CMENDTC
,_impdate = ASTDT/AENDT
,_impdateflag = %str(ASTDTF/AENDTF)
,_imputation_rule_date = %str(START/STOP));
All records with ASTDT <= &cutoff are included.
In addition,
If .<ASTDT <= &cutoff and AENDT > cutoff date, then
- CMENDTC is set to missing
- CMENRTPT = ‘ONGOING’
- CMENTPT = ‘Last Subject Encounter’
-
end;
else if CMSTDTC = ‘ ‘ and CMENDTC ne ‘ ‘ and CMENDTC<= &cutoff
then the record is included.
If CMSTDTC and CMENDTC are both missing then the record is
included.
DROP ASTDT and AENDT
CO If RDOMAIN = ‘IS’ then retain all obs where CODTC<= cutoff, else for
all other values of RDOMAIN, match with USUBJID /SEQ.
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RELREC Include all records If USUBJID = ‘ ’. for each domain in RDOMAIN,
match with USUBJID /SEQ if index(idvar,’SEQ’)>0; else match with
USUBJID/LNKID if index(idvar,’LNKID’)>0.
Appendix III: FDA 2010.1 Issue Summary
Check
ID Diagnostic Message FDA
Severity Dataset Count
(Issue
Rate) Explanation
SD1352 Duplicate records in
EC domain Warning EC 15 (< 0.1%) This is a false positive as per P21. ECSEQ values are unique for each
record within EC domain and within each Unique Subject Identifier
(USUBJID), Name of Treatment (ECTRT), Start Date/Time of
Treatment (ECSTDTC) and Mood (ECMOOD).
SD1149 Expected variable
with missing value
for all records Warning MB 2 (25.00%) As data is not collected for MBRESCAT and MBGRPID, this field is
currently set to NULL for all records.
SD1149 Expected variable
with missing value
for all records Warning MO 1 (16.67%) MOBLFL is derived based on last non-missing value on or before
DM.RFSTDTC. All records with MODTC populated are after their
respective RFSTDTC, therefore NULL values are expected for all the
records.
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