The ADMH dataset is based primarily on input from the SDTM MH dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL)
This is an example of an input SDTM MH datasets used to create the example ADMH dataset.Only variables needed for illustration are shown in the examples.
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This is an example of the ADMH dataset and associated metadata. This is just an example and does not mean to indicate that ADMH must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.
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admh.xpt
STUDYID
USUBJID
MHTERM
MHDECOD
MHBODSYS
ASTDT
AENDT
AOCCFL
AOCCPFL
AOCCSFL
TRTP
TRTA
SAFFL
RANDFL
TRTSDT
TRTEDT
MHCAT
MHSTDTC
MHENDTC
MHSEQ
A123
2001
ASTHMA
Asthma
Respiratory system disorders
Y
Y
Y
Product A
Product A
Y
Y
08JAN2021
28JAN2021
GENERAL MEDICAL HISTORY
2003
1
A123
2001
FREQUENT HEADACHES
Headache
Central and peripheral nervous system disorders
Y
Y
Product A
Product A
Y
Y
08JAN2021
28JAN2021
GENERAL MEDICAL HISTORY
2004-07
2
A123
2001
BROKEN LEG
Bone fracture
Musculoskeletal system disorders
15JUL2005
31AUG2005
Y
Y
Product A
Product A
Y
Y
08JAN2021
28JAN2021
GENERAL MEDICAL HISTORY
2005-07-15
2005-08-31
3
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ADMH Variable Metadata
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
Notes
STUDYID
Study Identifier
text
Req
MH.STUDYID
USUBJID
Unique Subject Identifier
text
Req
MH.USUBJID
ASTDT
Analysis Start Date
integer
Cond
Convert MH.MHSTDTC from character ISO8601 format to numeric date format
AENDT
Analysis End Date
integer
Cond
Convert MH.MHENDTC from character ISO8601 format to numeric date format
AOCCFL
1st Occurrence within Subject Flag
text
Y
Perm
Sort the data in the required order and flag the first for each subject.
AOCCPFL
1st Occurrence of Preferred Term Flag
text
Y
Perm
Sort the data in the required order and flag the first record for each MHDECOD for each subject.
AOCCSFL
1st Occurrence of SOC Flag
text
Y
Perm
Sort the data in the required order and flag the first record for each body system for each subject.