define.xml - ADAM - HF-1002-CL-101

Datasets

Dataset	Label	Class	Vars	Keys
`ADSL`	Subject-Level Analysis Dataset	Adsl	37	STUDYID, USUBJID
`ADAE`	Adverse Events Analysis Dataset	Occurrence Data Structure	32	STUDYID, USUBJID, ASTDT, AEDECOD, AESEQ
`ADEX`	Exposure Analysis Dataset	Basic Data Structure	15	STUDYID, USUBJID, PARAMCD
`ADLB`	Laboratory Analysis Dataset	Basic Data Structure	36	STUDYID, USUBJID, PARAMCD, AVISITN, ADT
`ADVS`	Vital Signs Analysis Dataset	Basic Data Structure	32	STUDYID, USUBJID, PARAMCD, AVISITN, ADT
`ADIMG`	Imaging Analysis Dataset	Basic Data Structure	32	STUDYID, USUBJID, PARAMCD, AVISITN
`ADEFF`	Efficacy Analysis Dataset	Basic Data Structure	32	STUDYID, USUBJID, PARAMCD, AVISITN

Variable definitions

ADSL Subject-Level Analysis Dataset

One record per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	ARM	Description of Planned Arm	Char	15	Derived
6	ARMCD	Planned Arm Code	Char	2	Derived
7	ACTARM	Description of Actual Arm	Char	15	Derived
8	ACTARMCD	Actual Arm Code	Char	2	Derived
9	COHORT	Cohort	Char	1	Derived
10	DOSELVL	Dose Level (vg)	Num	8	Derived
11	TRT01P	Planned Treatment for Period 01	Char	34	Derived
12	TRT01PN	Planned Treatment for Period 01 (N)	Num	8	Derived
13	TRT01A	Actual Treatment for Period 01	Char	34	Derived
14	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
15	AGE	Age	Num	8	Derived
16	AGEGR1	Pooled Age Group 1	Char	4	Derived
17	AGEGR1N	Pooled Age Group 1 (N)	Num	8	Derived
18	SEX	Sex	Char	1	Derived
19	RACE	Race	Char	25	Derived
20	ETHNIC	Ethnicity	Char	22	Derived
21	COUNTRY	Country	Char	3	Derived
22	HEIGHTBL	Baseline Height (cm)	Num	8	Derived
23	WEIGHTBL	Baseline Weight (kg)	Num	8	Derived
24	BMIBL	Baseline BMI (kg/m2)	Num	8	Derived
25	TRTSDT	Date of First Exposure to Treatment	Num	8	Derived
26	TRTEDT	Date of Last Exposure to Treatment	Num	8	Derived
27	TRTDURD	Total Treatment Duration (Days)	Num	8	Derived
28	EOSDT	End of Study Date	Num	8	Derived
29	TRSDURD	Total Time on Study (Days)	Num	8	Derived
30	DTHDT	Date of Death	Num	8	Derived
31	DTHFL	Subject Death Flag	Char	1	Derived
32	EOSSTT	End of Study Status	Char	12	Derived
33	DCSREAS	Reason for Discontinuation from Study	Char	21	Derived
34	ENRLFL	Enrolled Population Flag	Char	1	Derived
35	SAFFL	Safety Population Flag	Char	1	Derived
36	FASFL	Full Analysis Set Population Flag	Char	1	Derived
37	DLTFL	DLT-Evaluable Population Flag	Char	1	Derived

ADAE Adverse Events Analysis Dataset

One record per adverse event per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	TRTA	Actual Treatment	Char	34	Derived
6	TRTAN	Actual Treatment (N)	Num	8	Derived
7	TRT01A	Actual Treatment for Period 01	Char	34	Derived
8	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
9	COHORT	Cohort	Char	1	Derived
10	AGE	Age	Num	8	Derived
11	AGEGR1	Pooled Age Group 1	Char	4	Derived
12	SEX	Sex	Char	1	Derived
13	RACE	Race	Char	25	Derived
14	SAFFL	Safety Population Flag	Char	1	Derived
15	AESEQ	Sequence Number	Num	8	Derived	5
16	AETERM	Reported Term for the Adverse Event	Char	45	Predecessor
17	AEDECOD	Dictionary-Derived Term	Char	25	Predecessor	4
18	AEBODSYS	Body System or Organ Class	Char	52	Predecessor
19	ASTDT	Analysis Start Date	Num	8	Derived	3
20	AENDT	Analysis End Date	Num	8	Derived
21	ASTDY	Analysis Start Relative Day	Num	8	Derived
22	AENDY	Analysis End Relative Day	Num	8	Derived
23	ADURN	Analysis Duration (N)	Num	8	Derived
24	ATOXGR	Analysis Toxicity Grade	Char	1	Predecessor
25	AESER	Serious Event	Char	1	Predecessor
26	AREL	Analysis Causality	Char	16	Derived
27	AEOUT	Outcome of Adverse Event	Char	32	Derived
28	AEACN	Action Taken with Study Treatment	Char	14	Derived
29	TRTEMFL	Treatment Emergent Analysis Flag	Char	1	Derived
30	AOCCFL	1st Occurrence of Any AE Flag	Char	1	Derived
31	AOCCPFL	1st Occurrence of Preferred Term Flag	Char	1	Derived
32	AEDLTFL	Dose-Limiting Toxicity Flag	Char	1	Derived

ADEX Exposure Analysis Dataset

One record per exposure parameter per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	TRT01P	Planned Treatment for Period 01	Char	34	Derived
6	TRT01PN	Planned Treatment for Period 01 (N)	Num	8	Derived
7	TRT01A	Actual Treatment for Period 01	Char	34	Derived
8	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
9	COHORT	Cohort	Char	1	Derived
10	SAFFL	Safety Population Flag	Char	1	Derived
11	PARAMCD	Parameter Code	Char	6	Predecessor	3
12	PARAM	Parameter	Char	28	Predecessor
13	PARAMN	Parameter (N)	Num	8	Derived
14	AVAL	Analysis Value	Num	8	Predecessor
15	AVALU	Analysis Value Unit	Char	4	Derived

ADLB Laboratory Analysis Dataset

One record per parameter per analysis visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	TRT01P	Planned Treatment for Period 01	Char	34	Derived
6	TRT01PN	Planned Treatment for Period 01 (N)	Num	8	Derived
7	TRT01A	Actual Treatment for Period 01	Char	34	Derived
8	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
9	COHORT	Cohort	Char	1	Derived
10	AGE	Age	Num	8	Derived
11	AGEGR1	Pooled Age Group 1	Char	4	Derived
12	AGEGR1N	Pooled Age Group 1 (N)	Num	8	Derived
13	SEX	Sex	Char	1	Derived
14	RACE	Race	Char	25	Derived
15	ETHNIC	Ethnicity	Char	22	Derived
16	SAFFL	Safety Population Flag	Char	1	Derived
17	FASFL	Full Analysis Set Population Flag	Char	1	Derived
18	PARAMCD	Parameter Code	Char	8	Predecessor	3
19	PARAM	Parameter	Char	32	Predecessor
20	PARAMN	Parameter (N)	Num	8	Derived
21	PARCAT1	Parameter Category 1	Char	10	Derived
22	AVISIT	Analysis Visit	Char	8	Derived
23	AVISITN	Analysis Visit (N)	Num	8	Derived	4
24	ADT	Analysis Date	Num	8	Derived	5
25	ADY	Analysis Relative Day	Num	8	Derived
26	AVAL	Analysis Value	Num	8	Predecessor
27	AVALC	Analysis Value (C)	Char	5	Predecessor
28	BASE	Baseline Value	Num	8	Derived
29	CHG	Change from Baseline	Num	8	Derived
30	PCHG	Percent Change from Baseline	Num	8	Derived
31	ABLFL	Baseline Record Flag	Char	1	Derived
32	ANL01FL	Analysis Record Flag 01	Char	1	Derived
33	ANRLO	Analysis Normal Range Lower Limit	Num	8	Derived
34	ANRHI	Analysis Normal Range Upper Limit	Num	8	Derived
35	ANRIND	Analysis Reference Range Indicator	Char	6	Derived
36	BNRIND	Baseline Reference Range Indicator	Char	6	Derived

ADVS Vital Signs Analysis Dataset

One record per parameter per analysis visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	TRT01P	Planned Treatment for Period 01	Char	34	Derived
6	TRT01PN	Planned Treatment for Period 01 (N)	Num	8	Derived
7	TRT01A	Actual Treatment for Period 01	Char	34	Derived
8	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
9	COHORT	Cohort	Char	1	Derived
10	AGE	Age	Num	8	Derived
11	AGEGR1	Pooled Age Group 1	Char	4	Derived
12	AGEGR1N	Pooled Age Group 1 (N)	Num	8	Derived
13	SEX	Sex	Char	1	Derived
14	RACE	Race	Char	25	Derived
15	ETHNIC	Ethnicity	Char	22	Derived
16	SAFFL	Safety Population Flag	Char	1	Derived
17	FASFL	Full Analysis Set Population Flag	Char	1	Derived
18	PARAMCD	Parameter Code	Char	5	Predecessor	3
19	PARAM	Parameter	Char	31	Predecessor
20	PARAMN	Parameter (N)	Num	8	Derived
21	PARCAT1	Parameter Category 1	Char	11	Derived
22	AVISIT	Analysis Visit	Char	8	Derived
23	AVISITN	Analysis Visit (N)	Num	8	Derived	4
24	ADT	Analysis Date	Num	8	Derived	5
25	ADY	Analysis Relative Day	Num	8	Derived
26	AVAL	Analysis Value	Num	8	Predecessor
27	AVALC	Analysis Value (C)	Char	4	Predecessor
28	BASE	Baseline Value	Num	8	Derived
29	CHG	Change from Baseline	Num	8	Derived
30	PCHG	Percent Change from Baseline	Num	8	Derived
31	ABLFL	Baseline Record Flag	Char	1	Derived
32	ANL01FL	Analysis Record Flag 01	Char	1	Derived

ADIMG Imaging Analysis Dataset

One record per parameter per analysis visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	TRT01P	Planned Treatment for Period 01	Char	34	Derived
6	TRT01PN	Planned Treatment for Period 01 (N)	Num	8	Derived
7	TRT01A	Actual Treatment for Period 01	Char	34	Derived
8	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
9	COHORT	Cohort	Char	1	Derived
10	AGE	Age	Num	8	Derived
11	AGEGR1	Pooled Age Group 1	Char	4	Derived
12	AGEGR1N	Pooled Age Group 1 (N)	Num	8	Derived
13	SEX	Sex	Char	1	Derived
14	RACE	Race	Char	25	Derived
15	ETHNIC	Ethnicity	Char	22	Derived
16	SAFFL	Safety Population Flag	Char	1	Derived
17	FASFL	Full Analysis Set Population Flag	Char	1	Derived
18	PARAMCD	Parameter Code	Char	4	Predecessor	3
19	PARAM	Parameter	Char	38	Predecessor
20	PARAMN	Parameter (N)	Num	8	Derived
21	PARCAT1	Parameter Category 1	Char	16	Derived
22	AVISIT	Analysis Visit	Char	8	Derived
23	AVISITN	Analysis Visit (N)	Num	8	Derived	4
24	ADT	Analysis Date	Num	8	Derived
25	ADY	Analysis Relative Day	Num	8	Derived
26	AVAL	Analysis Value	Num	8	Predecessor
27	AVALC	Analysis Value (C)	Char	4	Predecessor
28	BASE	Baseline Value	Num	8	Derived
29	CHG	Change from Baseline	Num	8	Derived
30	PCHG	Percent Change from Baseline	Num	8	Derived
31	ABLFL	Baseline Record Flag	Char	1	Derived
32	ANL01FL	Analysis Record Flag 01	Char	1	Derived

ADEFF Efficacy Analysis Dataset

One record per parameter per analysis visit per subject

#	Variable	Label	Type	Len	Origin	Key
1	STUDYID	Study Identifier	Char	14	Predecessor	1
2	USUBJID	Unique Subject Identifier	Char	23	Predecessor	2
3	SUBJID	Subject Identifier for the Study	Char	4	Predecessor
4	SITEID	Study Site Identifier	Char	3	Predecessor
5	TRT01P	Planned Treatment for Period 01	Char	34	Derived
6	TRT01PN	Planned Treatment for Period 01 (N)	Num	8	Derived
7	TRT01A	Actual Treatment for Period 01	Char	34	Derived
8	TRT01AN	Actual Treatment for Period 01 (N)	Num	8	Derived
9	COHORT	Cohort	Char	1	Derived
10	AGE	Age	Num	8	Derived
11	AGEGR1	Pooled Age Group 1	Char	4	Derived
12	AGEGR1N	Pooled Age Group 1 (N)	Num	8	Derived
13	SEX	Sex	Char	1	Derived
14	RACE	Race	Char	25	Derived
15	ETHNIC	Ethnicity	Char	22	Derived
16	SAFFL	Safety Population Flag	Char	1	Derived
17	FASFL	Full Analysis Set Population Flag	Char	1	Derived
18	PARAMCD	Parameter Code	Char	8	Predecessor	3
19	PARAM	Parameter	Char	35	Predecessor
20	PARAMN	Parameter (N)	Num	8	Derived
21	PARCAT1	Parameter Category 1	Char	5	Derived
22	AVISIT	Analysis Visit	Char	8	Derived
23	AVISITN	Analysis Visit (N)	Num	8	Derived	4
24	ADT	Analysis Date	Num	8	Derived
25	ADY	Analysis Relative Day	Num	8	Derived
26	AVAL	Analysis Value	Num	8	Predecessor
27	AVALC	Analysis Value (C)	Char	5	Predecessor
28	BASE	Baseline Value	Num	8	Derived
29	CHG	Change from Baseline	Num	8	Derived
30	PCHG	Percent Change from Baseline	Num	8	Derived
31	ABLFL	Baseline Record Flag	Char	1	Derived
32	ANL01FL	Analysis Record Flag 01	Char	1	Derived

Controlled terminology

CT No Yes Response

Coded value	Decode
`N`	No
`Y`	Yes

CT Analysis Flag

Coded value	Decode
`Y`	Yes

CT Sex

Coded value	Decode
`M`	Male
`F`	Female

CT Pooled Age Group 1

Coded value	Decode
`<65`	< 65 years
`>=65`	>= 65 years

CT End of Study Status

Coded value	Decode
`COMPLETED`	Completed
`DISCONTINUED`	Discontinued
`ONGOING`	Ongoing

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