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IG33_SE_DM_001
IG33_SE_DM_002
IG33_SE_SE_001
IG33_SE_SE_002
Example
USUBJID
SUBJID
RFSTDTC
RFENDTC
SITEID
INVNAM
BIRTHDTC
AGE
AGEU
SEX
RACE
ETHNIC
ARMCD
ARM
ACTARMCD
ACTARM
ARMNRS
ACTARMUD
COUNTRY
IG33_SE_DM_001
789
001
2006-06-03
2006-06-17
01
SMITH, J
1948-12-13
57
YEARS
M
WHITE
HISPANIC OR LATINO
IO
IV-ORAL
IO
IV-ORAL
USA
IG33_SE_DM_001
790
002
2006-06-03
2006-06-17
01
SMITH, J
1955-03-22
51
YEARS
M
WHITE
NOT HISPANIC OR LATINO
OI
ORAL-IV
IO
IV-ORAL
USA
IG33_SE_DM_001
791
003
2006-06-03
2006-06-07
01
SMITH, J
1956-07-17
49
YEARS
M
WHITE
NOT HISPANIC OR LATINO
IO
IV-ORAL
IO
IV-ORAL
USA
Example
USUBJID
SUBJID
RFSTDTC
RFENDTC
SITEID
INVNAM
BIRTHDTC
AGE
AGEU
SEX
RACE
ETHNIC
ARMCD
ARM
ACTARMCD
ACTARM
ARMNRS
ACTARMUD
COUNTRY
IG33_SE_DM_002
123
012
2006-06-03
2006-06-10
01
JONES, D
1943-12-08
62
YEARS
M
ASIAN
HISPANIC OR LATINO
A
A
A
A
USA
IG33_SE_DM_002
456
103
2006-05-03
2006-07-30
01
JONES, D
1950-05-15
55
YEARS
F
WHITE
NOT HISPANIC OR LATINO
AR
A-Rescue
UNPLANNED TREATMENT
Drug B dispensed for part of Drug A element
USA
Example
USUBJID
SESEQ
ETCD
SESTDTC
SEENDTC
SEUPDES
TAETORD
EPOCH
IG33_SE_SE_001
789
1
SCREEN
2006-06-01
2006-06-03T10:32
1
SCREENING
IG33_SE_SE_001
789
2
IV
2006-06-03T10:32
2006-06-10T09:47
2
TREATMENT 1
IG33_SE_SE_001
789
3
ORAL
2006-06-10T09:47
2006-06-17
3
TREATMENT 2
IG33_SE_SE_001
789
4
FOLLOWUP
2006-06-17
2006-06-17
4
FOLLOW-UP
IG33_SE_SE_001
790
1
SCREEN
2006-06-01
2006-06-03T10:14
1
SCREENING
IG33_SE_SE_001
790
2
IV
2006-06-03T10:14
2006-06-10T10:32
3
TREATMENT 1
IG33_SE_SE_001
790
3
ORAL
2006-06-10T10:32
2006-06-17
2
TREATMENT 2
IG33_SE_SE_001
790
4
FOLLOWUP
2006-06-17
2006-06-17
4
FOLLOW-UP
IG33_SE_SE_001
791
1
SCREEN
2006-06-01
2006-06-03T10:17
1
SCREENING
IG33_SE_SE_001
791
2
IV
2006-06-03T10:17
2006-06-7
3
TREATMENT 1
Example
USUBJID
SESEQ
ETCD
SESTDTC
SEENDTC
SEUPDES
TAETORD
EPOCH
IG33_SE_SE_002
123
1
SCRN
2006-06-01
2006-06-03
1
SCREENING
IG33_SE_SE_002
123
2
DBA
2006-06-03
2006-06-10
2
BLINDED TREATMENT
IG33_SE_SE_002
456
1
SCRN
2006-05-01
2006-05-03
1
SCREENING
IG33_SE_SE_002
456
2
DBA
2006-05-03
2006-05-31
2
BLINDED TREATMENT
IG33_SE_SE_002
456
3
UNPLAN
2006-05-31
2006-06-13
Drug B dispensed in error
BLINDED TREATMENT
IG33_SE_SE_002
456
4
RSC
2006-06-13
2006-07-30
3
OPEN LABEL TREATMENT