Death
Sources: DB1, SDTM | Forms loaded: 4
DD (Death Details)
DM (Demographics)
Show domain info
Primary Domain
DD
All Domains
DD, DM
# Question Response / annotation
1
Date of death
field_001
DTHDTC
2
Autopsy performed
field_002
DDORRES when DDTESTCD = AUTOPSY
3
Primary cause of death
field_003
DDORRES when DDTESTCD = PRCDTH
4
Specify, if other
field_004
PRCDTHS in SUPPDD
5
Secondary cause for death
field_005
DDORRES when DDTESTCD = SECDTH
Demographics
Sources: DB1, SDTM | Forms loaded: 4
DM (Demographics)
RP (Reproductive System Findings)
Show domain info
Primary Domain
DM
All Domains
DM, RP
# Question Response / annotation
1
Sex
demog.SEX
SEX
2
Age
demog.AGE_RAW
AGE
3
Age units
demog.AGE_U
AGEU
4
Ethnicity
demog.ETHNIC
ETHNIC
5
Race
demog.RACE
RACE
6
Specify if Race is “Other”
demog.RACESP
RACESP in SUPPDM
7
Date of birth
demog.BIRTHDT_RAW
BRTHDTC
8
What is the subject’s childbearing status?
demog.CHILDPOT
RPORRES when RPTESTCD = CHILDPOT
Enrollment
Sources: DB1, SDTM | Forms loaded: 4
DM (Demographics)
DS (Disposition)
Show domain info
Primary Domain
DM
All Domains
DM, DS
# Question Response / annotation
1
Date Consent Form Signed
enrlment.ICDT_RAW
RFICDTC
DSSTDTC when DSDECOD = INFORMED CONSENT OBTAINED
2
Consent Version Number
enrlment.ICVERS
ICVERS in SUPPDS when DSDECOD = INFORMED CONSENT OBTAINED
3
Protocol Version
enrlment.PRTVERS
PRTVERS in SUPPDS when DSDECOD = INFORMED CONSENT OBTAINED
4
Date of Enrollment
enrlment.ENRLDT_RAW
DSSTDTC when DSDECOD = ENROLLED
5
Date of Randomization
enrlment.RANDDT_RAW
DSSTDTC when DSDECOD = RANDOMIZED
6
Randomization number
enrlment.RANDNO
DSREFID when DSDECOD = RANDOMIZED
Demographics (Screening)
Sources: DB1, SDTM | Forms loaded: 4
DM (Demographics)
Show domain info
Primary Domain
DM
All Domains
DM
# Question Response / annotation
1
Subject Identifier
SUBJID
SUBJID
USUBJID
2
Date of Birth
BRTHDAT
BRTHDTC
3
Sex
SEX
SEX
4
Race
RACE
RACE
5
Ethnicity
ETHNIC
ETHNIC
6
Country of Enrollment
COUNTRY
COUNTRY
7
Duration of Asthma Diagnosis (Years)
ASTHMA_DUR
ASTDUR in SUPPDM
8
Randomization Sequence (assigned by IRT after eligibility confirmed)
RANDOM_SEQ
ARMCD / ARM
9
Did the subject fail screening?
SCRN_FAIL
[NOT SUBMITTED]