Document text
Data Fitness Findings Report
IND27034
BioNTech SE and Pfizer , April 2021
Findings Notes
C4591001 EUA Amendment (12 -15 Years of Age)
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.
Document / Standard Version Notes
annotated CRF Seems fine
SDTM Implementation
Guide SDTM -IG v3.2
SDTM Controlled
Terminology 2020-03-27
SDTM define.xml V2.0 Seems fine
Medications Dictionary WHODD
GLOBALV3Mar20,
WHO DDE v202003
Medical Events
Dictionary
(MedDRA) V23.1
SDTM Reviewer’s Guide PhUSE template Seems fine
FDA-CBER-2021-5683-1060072
Data Issues
Adverse event marked as AEREL = RELATED, but subject didn’t receive dose yet
• USUBJID = C4591001 1226 12261520, AETERM = Pain at injection site , AESTDTC = 2020- 09-02T21:00
o 2 EX records: EXSTDTC = 2020- 09-03T15:06:00 and 2020- 09-22T10:22:00
Subjects have AE records with AEACN = DRUG WITHDRAWN but no ADVERSE EVENT record in DS
• 26 subjects – see report “ IND27034 - 12-15years - AEACN of DRUG WITHDRAWN but no DS ADVERSE EVENT record.xlsx ”
Duplicate value for CESEQ variable
• 1 record (0%)
• cSDRG explanation: “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.”
FDA-CBER-2021-5683-1060073
Value for CEHLGT not found in MedDRA dictionary
• 1 record (0%)
• cSDRG explanation: “Manually coded as "Virus infectious disorders". ”
• The correct value per the MedDRA dictionary is: Viral infectious disorders
NULL value in DDTEST variable marked as Required
• 2 records (4.17%)
NULL value in DDTESTCD variable marked as Required
• 2 records (4.17%)
Missing value for DDSTRESC, when DDSTAT is null
• 2 records (4.17%)
cSDRG explanation: “ Subject C4591001 1135 11351033 - official death certif icate 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. ”
Inconsistent coding of MHTERM
mhterm mhdecod mhhlt mhhlgt mhbodsys STUDYID count_of
_mhs meddrav
SKIN CANCER SKIN CANCER SKIN NEOPLASMS
MALIGNANT AND
UNSPECIFIED (EXCL
MELANOMA) SKIN NEOPLASMS
MALIGNANT AND UNSPECIFIED NEOPLASMS BENIGN,
MALIGNANT AND UNSPECIFIED (INCL
CYSTS AND POLYPS) C4591001 20 23.1
SKIN CANCER SKIN NEOPLASM
EXCISION SKIN LESION
EXCISIONS SKIN AND
SUBCUTANEOUS TISSUE THERAPEUTIC
PROCEDURES SURGICAL AND MEDICAL
PROCEDURES C4591001 1 23.1
FDA-CBER-2021-5683-1060074