Metadata and ADaM
Disclaimer
Any views or opinions presented in this
presentation are solely those of the author and do not necessarily represent those of the
company.
Agenda
• Introduction of ADaM Metadata
• Clincial Trial Process
• Examples of how to create Metadata
• Goal of ADaM Metadata
• Pros and Cons
• Conclusion
• Questions & Answers
ADaM Metadata
• Definition – Information of ADaM(Analysis Data Model) datasets
• Types
– Analysis Dataset Metadata – Analysis Variable Metadata
– Analysis Parameter Value Level Metadata
– Analysis Results Metadata
Normal Clinical Trial Process
Protocol SAP Mock Up
Tables
CRF
DMDB Raw Derived TFL
CDISC Clinical Trial Process
Protocol SAP Mock Up
Tables
eCRF
EDC SDTM
ADaM Metadata
TFL ADaM
ADaM Related Process
ADaM Related Process
Analysis Dataset Metadata
ADaM TFL Analysis Variable Metadata
Analysis Parameter value level Metadata
Analysis Results Metadata
ADaM Metadata
Example 1 - Time to Event Mock Up table
Table 14.2.1
Time to Death by Treatment PARAM = ‘Days to Death’, TRTP Analysis Population: Intent to Treat
ITTFL=‘Y’
Drug 1 Drug 2 p-value
__________________________________________________________________________________________
N xxx xxx
Median xx xx x.xx
Q1, Q3 xx, xx xx, xx
__________________________________________________________________________________________
AVAL(Days to Event), CNSR(Censor information)
proc lifetest data=ADTTEOS;
where PARAM=“Days to Death” and ITTFL=“Y”;
time AVAL*CNSR(1);
strata TRTP;
Time to Event Analysis Dataset Metadata
Dataset Name
Dataset Description
Dataset Location
Dataset Structure
Key Variables of Dataset
Class of Dataset
Documentation
ADTTEOS Overall Survival Analysis Dataset
adtteos.xpt One record per subject per
parameter
STUDYID, USUBJID, PARAM
BDS adtteos.txt
Example 1 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (1)
[CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Dataset Name
Parameter Identifier
Variable Name
Variable Label Variable Type
Display Format
Codelist / Controlled
Terms
Source / Derivation
ADTTEOS *ALL* STUDYID Study Identifier text $20 ADSL.STUDYID
ADTTEOS *ALL* USUBJID Unique Subject Identifier
text $20 ADSL.USUBJID
ADTTEOS *ALL* ITTFL Intent-To-Treat Population Flag
text $1 Y, null ADSL.ITTFL
ADTTEOS *ALL* TRTP Planned Treatment
text $40 Drug 1, Drug 2 ADSL.TRT01P
ADTTEOS *ALL* TRTPN Planned Treatment (N)
integer 1.0 1 = Drug 1, 2 = Drug 2
ADSL.TRT01PN
ADTTEOS PARAMCD PARAM Parameter text $50 Days to Death ADTTEOS *ALL* PARAMCD Parameter Code text $8 DEATH
Example 1 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (2)
[CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Dataset Name
Parameter Identifier
Variable Name
Variable Label
Variable Type
Display Format
Codelist / Controlled Terms
Source / Derivation
ADTTEOS *ALL* AVAL Analysis Value float 8.2 ADT – STARTDT + 1
ADTTEOS *ALL* STARTDT Time to Event Origin Date for Subject
integer YYYYMM DD10.
ADSL.RANDDT
ADTTEOS *ALL* ADT Analysis Date integer YYYYMM DD10.
SAS Date of DS.DSDTC
ADTTEOS *ALL* CNSR Censor integer 1.0 0, 1 0 for DS.DSDECOD =
‘DEATH’, 1 for any other study completion
ADTTEOS *ALL* EVNTDESC Event or Censoring Description
text $40 DEATH, COMPLETED THE STUDY, LOST TO FOLLOW-UP, AE, PD
DS.DSDECOD
Example 1 : Time to Event ADaM Dataset
[CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
USUBJID TRTP PARAM AVAL STARTDT ADT CNSR EVNTDESC
001 01 001 Study Drug 1 Days to Death
157 2011 01 04 2011 06 10 1 COMPLETED THE STUDY 001 01 002 Study Drug 2 Days to
Death
116 2011 02 01 2011 05 28 1 AE
001 01 003 Study Drug 2 Days to Death
88 2011 02 05 2011 05 04 0 DEATH
001 01 004 Study Drug 1 Days to Death
102 2011 03 20 2011 06 30 1 PD
Example 1 : Time to Event Analysis Results Metadata
Metadata Field Metadata
DISPLAY IDENTIFIER
Table 14.2.1
DISPLAY NAME Time to Death by Treatment, Analysis Population: Intent to Treat RESULT
IDENTIFIER
Days to Death PARAM Days to Death
PARAMCD DEATH
ANALYSIS VARIABLE
AVAL
REASON Primary efficacy analysis
DATASET ADTTEOS
SELECTION CRITERIA
ITTFL=“Y” and PARAM = ‘Days to Death’
DOCUMENTATION See SAP Section XX for details. Program: t-14-012-001-death.txt PROGRAMMING
STATEMENTS
proc lifetest data= ADTTEOS;
where ITTFL=‘Y’ and PARAM = “Days to Death”;
time AVAL*CNSR(1);
Example 2 : Time to Event Mock Up table
Table 14.2.2
Time to Progression Free Survival : Cox Proportional Hazard Model PARAM = ‘Days to Progression Free Survival’, TRTP
Analysis Population: Intent to Treat ITTFL=‘Y’
Drug 1 Drug 2 p-value
__________________________________________________________________________________________
N xxx xxx
Median xx xx x.xx
Q1, Q3 xx, xx xx, xx
__________________________________________________________________________________________
AVAL(Days to Event), CNSR(Censor information)
proc phreg data=ADTTEOS;
where PARAM=“Days to Progression Free Survival” and ITTFL=“Y”;
model AVAL*CNSR(1) = TRTP AGE SEX ; run;
Example 2 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (1)
[CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Dataset
Name Parameter
Identifier Variable
Name Variable Label Variable
Type Display
Format Codelist /
Controlled Terms Source / Derivation
ADTTEOS *ALL* STUDYID Study Identifier text $20 ADSL.STUDYID
ADTTEOS *ALL* USUBJID Unique Subject Identifier
text $20 ADSL.USUBJID
ADTTEOS *ALL* AGE Age integer 3.0 ADSL.AGE
ADTTEOS *ALL* SEX Sex text $1 ADSL.SEX
ADTTEOS *ALL* ITTFL Intent-To-Treat Population Flag
text $1 Y, null ADSL.ITTFL
ADTTEOS *ALL* TRTP Planned Treatment
text $40 Drug 1, Drug 2 ADSL.TRT01P
ADTTEOS *ALL* TRTPN Planned Treatment (N)
integer 1.0 1 = Drug 1, 2 = Drug 2
ADSL.TRT01PN
ADTTEOS PARAMCD PARAM Parameter text $50 Days to Death
Days to Progression
Example 2 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (2)
Dataset Name
Parameter Identifier
Variable Name
Variable Label
Variable Type
Display Format
Codelist / Controlled Terms
Source / Derivation
ADTTEOS *ALL* AVAL Analysis Value float 8.2 ADT – STARTDT + 1
ADTTEOS *ALL* STARTDT Time to Event Origin Date for Subject
integer YYYYMM DD10.
ADSL.RANDDT
ADTTEOS *ALL* ADT Analysis Date integer YYYYMM DD10.
SAS Date of DS.DSDTC
ADTTEOS DEATH CNSR Censor integer 1.0 0, 1 0 for DS.DSDECOD =
‘DEATH’, 1 for any other study completion
ADTTEOS PFS CNSR Censor integer 1.0 0, 1 0 for DS.DSDECOD
in(‘DEATH’ , ‘PD’), 1 for any other study completion ADTTEOS *ALL* EVNTDESC Event or
Censoring Description
text $40 DEATH, COMPLETED THE STUDY, LOST TO FOLLOW-UP, AE, PD
DS.DSDECOD
Example 2 : Time to Event ADaM Dataset
[CB1]Note to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
USUBJ ID
AGE SEX TRTP PARAM AVA L
STAR TDT
ADT CNSR EVNTDESC
001 01 001
43 M Study
Drug 1
Days to Death 157 2011 01 04
2011 06 10
1 COMPLETED
THE STUDY 001 01
002
57 F Study
Drug 2
Days to Death 116 2011 02 01
2011 05 28
1 AE
001 01 003
71 M Study
Drug 2
Days to Death 88 2011 02 05
2011 05 04
0 DEATH
001 01 004
55 F Study
Drug 1
Days to Death 102 2011 03 20
2011 06 30
1 PD
001 01 001
43 M Study
Drug 1
Days to Progression Free Survival
157 2011 01 04
2011 06 10
1 COMPLETED
THE STUDY 001 01
002
57 F Study
Drug 2
Days to Progression Free Survival
116 2011 02 01
2011 05 28
1 AE
001 01 003
71 M Study
Drug 2
Days to Progression Free Survival
88 2011 02 05
2011 05 04
0 DEATH
Example 2 : Time to Event Analysis Results Metadata
Metadata Field Metadata
DISPLAY IDENTIFIER
Table 14.2.2
DISPLAY NAME Time to Progression Free Survival : Cox Proportional Hazard Model RESULT
IDENTIFIER
Days to Progression Free Survival PARAM Days to Progression Free Survival
PARAMCD PFS
ANALYSIS VARIABLE
AVAL
REASON Secondary efficacy analysis
DATASET ADTTEOS
SELECTION CRITERIA
ITTFL=“Y” and PARAM=“Days to Progression Free Survival’
DOCUMENTATION See SAP Section XX for details. Program: t-14-002-002-pfs.txt PROGRAMMING
STATEMENTS
proc phreg data= ADTTEOS;
where ITTFL=‘Y’ and PARAM = “Days to Progression Free Survival’;
model AVAL*CNSR(1) = TRTP AGE SEX;
