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C4591001: R oadmap for Event Selection and SDTM Dataset Updates for Reactogenicity
Background: As discussed with the Agency on 08 April 2021, any events reported in the general
adverse event data (AE domain ) which meet criteria for reactogenicity have been added to the FACE
and VS domains and used to update the summary records in the CE domain , as described below.
Add a flag in SUPPDM : QNAM=REACTOFL, QLABEL=Reactogenicity Population Fl ag
For vaccinated subjects (DM.RFXSTDTC non- missing):
a. Assign QVAL as “N” if “NO - REACTOGENICITY E -DIARY NOT COLLECTED FOR THIS SUBJECT ” was
selected in REACTOGENICITY DIARY CRF
b. Otherwise assigned as “Y”
Select from AE data: If AECAT = “ ADVERSE EVENT ” and AEREL =
‘RELATED’ and AEDECOD in (preferred term list corresponding to
pre-defined reactogenicity symptoms – see Table 1 below) and
occurs within 7 days of Vax 1 or Vax 2).
If meet both criteria, then a dd flag in SUPPAE to identify that these
meet reactogenicity criteria ( QVAL = “Y” where QNAM = “ REACCRIT ”)
Select subjects from SUPPDM
with QVAL = “Y” where
QNAM = REACTOF L
Reactogenicity Symptom
(CETERM) PT (AEDECOD)
PAIN AT INJECTION SITE Injection site pain
Vaccination site pain
REDNESS Injection site erythema
Vaccination site erythema
SWELLING Injection site swelling
Vaccination site swelling
FEVER Pyrexia
Body temperature increased
VOMITING Vomiting
DIARRHEA Diarrhoea
HEADACHE Headache
FATIGUE Fatigue
CHILLS Chills
NEW OR WORSENED
MUSCLE PAIN Myalgia
NEW OR WORSENED JOINT
PAIN Arthralgia
Y Start
Table 1
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AETOXGR Severity
1 MILD
2 MODERATE
3 SEVERE
4 POTENTIALLY LIFE THREATENING Add records to FACE for investigator’s assessment from
AE form :
a. For each day AE overlaps with diary period,
insert a pair of records for FATESTCD =
‘OCCUR’ (set to ‘Y’) and FATEST CD = ‘SEV’
(from AETOXGR, converted to severity
according to Table 2 below) for that date
(FADTC) .
b. Assign FAOBJ based on the symptom corresponding to AEDECOD (CETERM from
Table 1) .
c. FACAT = “ REACTOGENICITY – ADVERSE
EVENT ”.
d. FASCAT (“SYSTEMIC” or “ADMINISTRATION
SITE”) assigned based on FAOBJ.
e. FASPID is assigned the value of AESPID from
source AE record.
f. FAEVAL = ‘INVESTIGATOR’.
For general AE records identified
as meeting r eactogenicity criteria
(SUPPAE. QNAM .REACCRIT = “Y”):
Fever? Y N
Add records to VS for investigator’s assessment from
AE form :
a. For each day AE overlaps with diary period,
insert a record for VSTESTCD = ‘TEMP’:
VSORRES is null, VSSTRESC = “FEVER” for that date (VSDTC).
b. VSDRVDL is set to “Y”.
c. VSCAT = “ REACTOGENICITY – ADVERSE
EVENT ”.
d. VSSCAT = “SYSTEMIC” .
e. VSSPID is assigned the value of AESPID from
source AE record.
f. VSEVAL = ‘INVESTIGATOR’.
Table 2
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a. Flag in SUPPCE that event was modified based on AE data (QNAM =
‘AE_MOD’)
b. Create record in SUPPCE with QNAM = ‘CEDIFFRS’/QLABEL = ‘Reason
Investigator Changed Assessment’.
c. Assign SUPPCE.CEEVAL = “INVESTIGATOR”.
When general AE data affects the
corresponding summary event
record in CE CE/SUPPCE updates
a. Re-derive CESTDTC by taking the earliest of
AESTDTC and original CESTDTC .
b. Re-derive CEENDTC by taking the latest of
AEENDTC and original CEENDTC.
c. For any date changes, write original date to
SUPPCE.CESTDTC1 and/or CEENDTC1.
d. CESTDY/CEENDY/CEDUR are updated based on
any changes to CESTDTC/CEENDTC.
e. Re-derive CESEV by taking the maximum severity
from AETOXGR (mapped to severity according to
Table 2) or original CESEV. If AE severity is worse than original CESEV, then write out original value
to SUPPCE where QNAM = CESEV1. Note:
Severity is not assigned for Fever events.
f. If stop date is after diary period, then assign
CEENRTPT = “ ONGOING ” and CEENTPT = “ DAY 7 ”.
a. Assign CEOCCUR= “Y” and set
CESTAT/CEREASND/CEDRVFL to null.
b. Populate CESTDTC/CEENDTC with
AESTDTC/AEENDTC.
c. Derive CESTDY/CEENDY and CEDUR.
d. Set CESEV based on AETOXGR, mapped to severity values in Table 2.
e. If stop date is after diary period, then assign CEENRTPT = “ ONGOING ” and
CEENTPT = “ DAY 7 ”.
Originally CEOCCUR was “Y”
Originally CEOCCUR was not “Y”
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Add or update records to AE dataset where AECAT =
‘REACTOGENICITY’ .
a. Calculate AEDUR based on time occurring after diary
period using updated CEENDTC .
b. Derive AE ELTM.
c. AESEV can be populated using AETOXGR, mapped to
severity from Table 2.
Update RELREC to link any newly added records.
Link source general AE records to updated CE records.
End
Identify events from updated CE
which went past the diary period
(CEENRTPT = “ONGOING” )
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