%let path=/folders/myfolders/cdisc_ucsd;
libname adm "&path/adam";SAS Connection established. Subprocess id is 2845<!DOCTYPE html PUBLIC “-//W3C//DTD HTML 4.01//EN” “http://www.w3.org/TR/html4/strict.dtd”>
34 ods listing close;ods html5 (id=saspy_internal) file=stdout options(bitmap_mode='inline') device=svg style=HTMLBlue; ods
34 ! graphics on / outputfmt=png;
NOTE: Writing HTML5(SASPY_INTERNAL) Body file: STDOUT
35
36 %let path=/folders/myfolders/cdisc_ucsd;
37
38 libname adm "&path/adam";
NOTE: Libref ADM was successfully assigned as follows:
Engine: V9
Physical Name: /folders/myfolders/cdisc_ucsd/adam
39
40 ods html5 (id=saspy_internal) close;ods listing;
41
%macro import_adam_xls(excel);
options nostimer;
libname myexcel xlsx "&excel";
proc sql noprint;
select memname into :sheet1-
from dictionary.tables
where libname="MYEXCEL";
quit;
%do i=1 %to &sqlobs;
data adm.&&sheet&i;
set myexcel."&&sheet&i"n;
run;
%end;
libname myexcel clear;
%mend import_adam_xls;<!DOCTYPE html PUBLIC “-//W3C//DTD HTML 4.01//EN” “http://www.w3.org/TR/html4/strict.dtd”>
691 ods listing close;ods html5 (id=saspy_internal) file=stdout options(bitmap_mode='inline') device=svg style=HTMLBlue; ods
691! graphics on / outputfmt=png;
NOTE: Writing HTML5(SASPY_INTERNAL) Body file: STDOUT
692
693 %macro import_adam_xls(excel);
694 options nostimer;
695 libname myexcel xlsx "&excel";
696
697 proc sql noprint;
698 select memname into :sheet1-
699 from dictionary.tables
700 where libname="MYEXCEL";
701 quit;
702
703 %do i=1 %to &sqlobs;
704 data cdiscadm.&&sheet&i;
705 set myexcel."&&sheet&i"n;
706 run;
707 %end;
708
709 libname myexcel clear;
710
711 %mend import_adam_xls;
712
713 ods html5 (id=saspy_internal) close;ods listing;
714
%import_adam_xls(&path/adam_metadata.xlsx)<!DOCTYPE html PUBLIC “-//W3C//DTD HTML 4.01//EN” “http://www.w3.org/TR/html4/strict.dtd”>
716 ods listing close;ods html5 (id=saspy_internal) file=stdout options(bitmap_mode='inline') device=svg style=HTMLBlue; ods
716! graphics on / outputfmt=png;
NOTE: Writing HTML5(SASPY_INTERNAL) Body file: STDOUT
717
718 %import_adam_xls(&path/adam_metadata.xlsx)
NOTE: Libref MYEXCEL was successfully assigned as follows:
Engine: XLSX
Physical Name: /folders/myfolders/cdisc_ucsd/adam_metadata.xlsx
NOTE: The import data set has 5 observations and 11 variables.
NOTE: There were 5 observations read from the data set MYEXCEL.ANALYSIS_RESULTS.
NOTE: The data set CDISCADM.ANALYSIS_RESULTS has 5 observations and 11 variables.
NOTE: The import data set has 64 observations and 11 variables.
NOTE: There were 64 observations read from the data set MYEXCEL.CODELISTS.
NOTE: The data set CDISCADM.CODELISTS has 64 observations and 11 variables.
NOTE: The import data set has 2 observations and 2 variables.
NOTE: There were 2 observations read from the data set MYEXCEL.COMPUTATION_METHOD.
NOTE: The data set CDISCADM.COMPUTATION_METHOD has 2 observations and 2 variables.
NOTE: The import data set has 1 observations and 9 variables.
NOTE: There were 1 observations read from the data set MYEXCEL.DEFINE_HEADER_METADATA.
NOTE: The data set CDISCADM.DEFINE_HEADER_METADATA has 1 observations and 9 variables.
NOTE: The import data set has 6 observations and 4 variables.
NOTE: There were 6 observations read from the data set MYEXCEL.EXTERNAL_LINKS.
NOTE: The data set CDISCADM.EXTERNAL_LINKS has 6 observations and 4 variables.
NOTE: The import data set has 11 observations and 11 variables.
NOTE: There were 11 observations read from the data set MYEXCEL.TOC_METADATA.
NOTE: The data set CDISCADM.TOC_METADATA has 11 observations and 11 variables.
NOTE: The import data set has 3 observations and 14 variables.
NOTE: There were 3 observations read from the data set MYEXCEL.VALUELEVEL_METADATA.
NOTE: The data set CDISCADM.VALUELEVEL_METADATA has 3 observations and 14 variables.
NOTE: The import data set has 128 observations and 16 variables.
NOTE: There were 128 observations read from the data set MYEXCEL.VARIABLE_METADATA.
NOTE: The data set CDISCADM.VARIABLE_METADATA has 128 observations and 16 variables.
NOTE: Libref MYEXCEL has been deassigned.
719
720 ods html5 (id=saspy_internal) close;ods listing;
721
# Display the contents of the the "ADM" library proc datasets lib=adm;
run;
quit;| Directory | |
|---|---|
| Libref | ADM |
| Engine | V9 |
| Physical Name | /folders/myfolders/cdisc_ucsd/adam |
| Filename | /folders/myfolders/cdisc_ucsd/adam |
| Inode Number | 1233 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 4KB |
| File Size (bytes) | 4096 |
| # | Name | Member Type | File Size | Last Modified |
|---|---|---|---|---|
| 1 | ANALYSIS_RESULTS | DATA | 128KB | 10/13/2019 22:10:29 |
| 2 | CODELISTS | DATA | 128KB | 10/13/2019 22:10:29 |
| 3 | COMPUTATION_METHOD | DATA | 128KB | 10/13/2019 22:10:29 |
| 4 | DEFINE_HEADER_METADATA | DATA | 128KB | 10/13/2019 22:10:29 |
| 5 | EXTERNAL_LINKS | DATA | 128KB | 10/13/2019 22:10:29 |
| 6 | TOC_METADATA | DATA | 128KB | 10/13/2019 22:10:29 |
| 7 | VALUELEVEL_METADATA | DATA | 128KB | 10/13/2019 22:10:29 |
| 8 | VARIABLE_METADATA | DATA | 128KB | 10/13/2019 22:10:29 |
proc contents data=adm.ANALYSIS_RESULTS;
run;The CONTENTS Procedure
| Data Set Name | ADM.ANALYSIS_RESULTS | Observations | 5 |
|---|---|---|---|
| Member Type | DATA | Variables | 11 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 461 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 142 |
| Obs in First Data Page | 5 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/analysis_results.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1247 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 7 | ANALYSISDATASET | Char | 5 | $5. | $5. | ANALYSISDATASET |
| 6 | ANALYSISVARIABLES | Char | 22 | $22. | $22. | ANALYSISVARIABLES |
| 1 | DISPLAYID | Char | 13 | $13. | $13. | DISPLAYID |
| 2 | DISPLAYNAME | Char | 47 | $47. | $47. | DISPLAYNAME |
| 9 | DOCUMENTATION | Char | 24 | $24. | $24. | DOCUMENTATION |
| 5 | PARAMLIST | Char | 41 | $41. | $41. | PARAMLIST |
| 11 | PROGRAM | Char | 1 | $1. | $1. | PROGRAM |
| 10 | PROGRAMMINGCODE | Char | 153 | $153. | $153. | PROGRAMMINGCODE |
| 4 | REASON | Char | 58 | $58. | $58. | REASON |
| 3 | RESULTID | Char | 43 | $43. | $43. | RESULTID |
| 8 | SELECTIONCRITERIA | Char | 54 | $54. | $54. | SELECTIONCRITERIA |
proc print data=adm.ANALYSIS_RESULTS;
run;| Obs | DISPLAYID | DISPLAYNAME | RESULTID | REASON | PARAMLIST | ANALYSISVARIABLES | ANALYSISDATASET | SELECTIONCRITERIA | DOCUMENTATION | PROGRAMMINGCODE | PROGRAM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Table_14.1.1 | Summary of Demographics (ITT Population) | Summary of Demographics | Comparisons of baseline characteristics by treatment group | AGE, AGEGR1, SEX, RACE | ADSL | Where ITTFL=‘Y’ | [r]SAP_Section_9.1.1[ | PROC FREQ DATA=ADSL; where ittfl=‘Y’; tables trt01pn * (agegr1 sex race) / cmh; | ||
| 2 | Table_14.2.1 | Responder Analysis by Visit | Responder Analysis by Visit | Efficacy endpoint pre-specified in SAP | XPPAIN/Pain Score | CRIT1FL | ADEF | Where ITTFL=‘Y’ and ABLFL ^= ‘Y’ and PARAMCD=‘XPPAIN’ | [r]SAP_Section_9.2.1[ | proc freq data = adef; by crit1 avisitn; where ittfl=‘y’; tables trtpn * crit1fl / chisq; run; | |
| 3 | Table_14.2.2 | Mean Pain Assessments and Changes from Baseline | Summary of Pain Relief | Efficacy endpoint pre-specified in SAP | XPPAIN/Pain Score | AVAL, CHG | ADEF | Where ITTFL=‘Y’ and ABLFL ^= ‘Y’ and PARAMCD=‘XPPAIN’ | [r]SAP_Section_9.2.1[ | proc glm data = adef; by avisitn avisit; class trtpn; model aval = trtpn base; run; | |
| 4 | Figure_14.2.1 | Time to Pain Relief Analysis by Treatment Group | Time to Pain Relief Kaplan Meier Analysis | Pre-specified in SAP | TTPNRELF/Time to First Pain Relief (Days) | AVAL | ADTTE | Where ITTFL=‘Y’ | [r]SAP_Section_9.2.2[ | proc lifetest data = adtte plots=s; where ittfl = ‘Y’ and paramcd = ‘TTPNRELF’; id usubjid; strata trtpn; time aval*cnsr (1 2 3); test trtpn; run; | |
| 5 | Figure_14.2.1 | Time to Pain Relief Analysis by Treatment Group | Time to Pain Relief Hazard Ratio Derivation | Pre-specified in SAP | TTPNRELF/Time to First Pain Relief (Days) | AVAL | ADTTE | Where ITTFL=‘Y’ | [r]SAP_Section_9.2.2[ | proc phreg data = adtte; model aval*cnsr(1, 2, 3) = trtpn; run; |
proc contents data=adm.CODELISTS;
run;The CONTENTS Procedure
| Data Set Name | ADM.CODELISTS | Observations | 64 |
|---|---|---|---|
| Member Type | DATA | Variables | 11 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 144 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 454 |
| Obs in First Data Page | 64 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/codelists.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1248 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 3 | CODEDVALUE | Char | 51 | $51. | $51. | CODEDVALUE |
| 6 | CODELISTDICTIONARY | Char | 6 | $6. | $6. | CODELISTDICTIONARY |
| 1 | CODELISTNAME | Char | 11 | $11. | $11. | CODELISTNAME |
| 7 | CODELISTVERSION | Char | 3 | $3. | $3. | CODELISTVERSION |
| 8 | H | Char | 1 | $1. | $1. | H |
| 9 | I | Char | 1 | $1. | $1. | I |
| 10 | J | Char | 1 | $1. | $1. | J |
| 11 | K | Char | 1 | $1. | $1. | K |
| 2 | RANK | Num | 8 | 15. | RANK | |
| 4 | TRANSLATED | Char | 51 | $51. | $51. | TRANSLATED |
| 5 | TYPE | Char | 7 | $7. | $7. | TYPE |
proc print data=adm.CODELISTS;
run;| Obs | CODELISTNAME | RANK | CODEDVALUE | TRANSLATED | TYPE | CODELISTDICTIONARY | CODELISTVERSION | H | I | J | K |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACN | 1 | DOSE INCREASED | DOSE INCREASED | TEXT | ||||||
| 2 | ACN | 2 | DOSE NOT CHANGED | DOSE NOT CHANGED | TEXT | ||||||
| 3 | ACN | 3 | DOSE REDUCED | DOSE REDUCED | TEXT | ||||||
| 4 | ACN | 4 | DRUG INTERRUPTED | DRUG INTERRUPTED | TEXT | ||||||
| 5 | ACN | 5 | DRUG WITHDRAWN | DRUG WITHDRAWN | TEXT | ||||||
| 6 | ACN | 6 | NOT APPLICABLE | NA | TEXT | ||||||
| 7 | ACN | 7 | UNKNOWN | U; Unknown | TEXT | ||||||
| 8 | AEBODSYS | 1 | TEXT | MedDRA | 7.0 | ||||||
| 9 | AEDECOD | 1 | TEXT | MedDRA | 7.0 | ||||||
| 10 | AEREL | 1 | NOT RELATED | NOT RELATED | TEXT | ||||||
| 11 | AEREL | 2 | POSSIBLY RELATED | POSSIBLY RELATED | TEXT | ||||||
| 12 | AEREL | 3 | PROBABLY RELATED | PROBABLY RELATED | TEXT | ||||||
| 13 | AESEV | 1 | MILD | Grade 1; 1 | TEXT | ||||||
| 14 | AESEV | 2 | MODERATE | Grade 2; 2 | TEXT | ||||||
| 15 | AESEV | 3 | SEVERE | Grade 3; 3 | TEXT | ||||||
| 16 | AGEU | 1 | YEARS | YEARS | TEXT | ||||||
| 17 | ARM | 1 | Analgezia HCL 30 mg | Analgezia HCL 30 mg | TEXT | ||||||
| 18 | ARM | 2 | Placebo | Placebo | TEXT | ||||||
| 19 | ARMCD | 1 | ALG123 | Analgezia HCL 30 mg | TEXT | ||||||
| 20 | ARMCD | 2 | PLACEBO | Placebo | TEXT | ||||||
| 21 | COUNTRY | 1 | USA | UNITED STATES | TEXT | ||||||
| 22 | ROLECODE | 1 | Grouping Qualifier | Grouping Qualifier | TEXT | ||||||
| 23 | ROLECODE | 2 | Identifier | Identifier | TEXT | ||||||
| 24 | ROLECODE | 3 | Record Qualifier | Record Qualifier | TEXT | ||||||
| 25 | ROLECODE | 4 | Rule | Rule | TEXT | ||||||
| 26 | ROLECODE | 5 | Result Qualifier | Result Qualifier | TEXT | ||||||
| 27 | ROLECODE | 6 | Synonym Qualifier | Synonym Qualifier | TEXT | ||||||
| 28 | ROLECODE | 7 | Timing | Timing | TEXT | ||||||
| 29 | ROLECODE | 8 | Topic | Topic | TEXT | ||||||
| 30 | SEX | 1 | F | FEMALE | TEXT | ||||||
| 31 | SEX | 2 | M | MALE | TEXT | ||||||
| 32 | SEX | 3 | U | UNKNOWN | TEXT | ||||||
| 33 | VISIT | 1 | Baseline | Baseline | TEXT | ||||||
| 34 | VISIT | 2 | 3 Months | Month 3 | TEXT | ||||||
| 35 | VISIT | 3 | 6 Months | Month 6 | TEXT | ||||||
| 36 | _0N1Y | 2 | Y | YES | TEXT | ||||||
| 37 | _0N1Y | 1 | N | NO | TEXT | ||||||
| 38 | TRT01PN | 2 | 1 | Analgezia HCL 30 mg | NUMERIC | ||||||
| 39 | TRT01PN | 1 | 0 | Placebo | NUMERIC | ||||||
| 40 | PAINSCORE | 1 | 1 | Mild | NUMERIC | ||||||
| 41 | PAINSCORE | 2 | 2 | Moderate | NUMERIC | ||||||
| 42 | PAINSCORE | 3 | 3 | Mild | NUMERIC | ||||||
| 43 | AVISITN | 1 | 0 | Baseline | NUMERIC | ||||||
| 44 | AVISITN | 2 | 1 | Month 3 | NUMERIC | ||||||
| 45 | AVISITN | 3 | 2 | Month 6 | NUMERIC | ||||||
| 46 | AERELN | 1 | 0 | NOT RELATED | NUMERIC | ||||||
| 47 | AERELN | 2 | 1 | POSSIBLY RELATED | NUMERIC | ||||||
| 48 | AERELN | 3 | 2 | PROBABLY RELATED | NUMERIC | ||||||
| 49 | AESEVN | 1 | 1 | Mild | NUMERIC | ||||||
| 50 | AESEVN | 2 | 2 | Moderate | NUMERIC | ||||||
| 51 | AESEVN | 3 | 3 | Severe | NUMERIC | ||||||
| 52 | RELGR1N | 1 | 1 | Not related | NUMERIC | ||||||
| 53 | RELGR1N | 1 | 2 | Related | NUMERIC | ||||||
| 54 | EVNTDESC | 1 | PAIN RELIEF | Pain relief | TEXT | ||||||
| 55 | EVNTDESC | 2 | PAIN WORSENING PRIOR TO RELIEF | Pain worsening prior to relief | TEXT | ||||||
| 56 | EVNTDESC | 3 | PAIN ADVERSE EVENT PRIOR TO RELIEF | Pain adverse event prior to relief | TEXT | ||||||
| 57 | EVNTDESC | 4 | COMPLETED STUDY PRIOR TO RELIEF | Completed study prior to relief | TEXT | ||||||
| 58 | RELGR1 | 1 | Not related | Not related | TEXT | ||||||
| 59 | RELGR1 | 2 | Related | Related | TEXT | ||||||
| 60 | CRIT1VALUES | 1 | Pain improvement from baseline of at least 2 points | Pain improvement from baseline of at least 2 points | TEXT | ||||||
| 61 | CENSOR | 1 | 0 | Pain relief | NUMERIC | ||||||
| 62 | CENSOR | 2 | 1 | Pain worsening prior to relief | NUMERIC | ||||||
| 63 | CENSOR | 3 | 2 | Pain adverse event prior to relief | NUMERIC | ||||||
| 64 | CENSOR | 4 | 3 | Completed study prior to relief | NUMERIC |
proc contents data=adm.COMPUTATION_METHOD;
run;The CONTENTS Procedure
| Data Set Name | ADM.COMPUTATION_METHOD | Observations | 2 |
|---|---|---|---|
| Member Type | DATA | Variables | 2 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 75 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 871 |
| Obs in First Data Page | 2 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/computation_method.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1249 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 2 | COMPUTATIONMETHOD | Char | 57 | $57. | $57. | COMPUTATIONMETHOD |
| 1 | COMPUTATIONMETHODOID | Char | 18 | $18. | $18. | COMPUTATIONMETHODOID |
proc print data=adm.COMPUTATION_METHOD;
run;| Obs | COMPUTATIONMETHODOID | COMPUTATIONMETHOD |
|---|---|---|
| 1 | CHANGEFROMBASELINE | AVAL-BASE |
| 2 | RESPONDER | IF (.Z<CHG<=-2) THEN CRIT1FL=‘Y’ ELSE CRIT1FL=‘N’ |
proc contents data=adm.DEFINE_HEADER_METADATA;
run;The CONTENTS Procedure
| Data Set Name | ADM.DEFINE_HEADER_METADATA | Observations | 1 |
|---|---|---|---|
| Member Type | DATA | Variables | 9 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 256 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 255 |
| Obs in First Data Page | 1 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/define_header_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1250 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 1 | FILEOID | Char | 6 | $6. | $6. | FILEOID |
| 5 | PROTOCOLNAME | Char | 6 | $6. | $6. | PROTOCOLNAME |
| 8 | SCHEMALOCATION | Char | 56 | $56. | $56. | SCHEMALOCATION |
| 6 | STANDARD | Char | 4 | $4. | $4. | STANDARD |
| 4 | STUDYDESCRIPTION | Char | 132 | $132. | $132. | STUDYDESCRIPTION |
| 3 | STUDYNAME | Char | 6 | $6. | $6. | STUDYNAME |
| 2 | STUDYOID | Num | 8 | BEST. | STUDYOID | |
| 9 | STYLESHEET | Char | 26 | $26. | $26. | STYLESHEET |
| 7 | VERSION | Num | 8 | BEST. | VERSION | |
proc print data=adm.DEFINE_HEADER_METADATA;
run;| Obs | FILEOID | STUDYOID | STUDYNAME | STUDYDESCRIPTION | PROTOCOLNAME | STANDARD | VERSION | SCHEMALOCATION | STYLESHEET |
|---|---|---|---|---|---|---|---|---|---|
| 1 | XYZ123 | 123 | XYZ123 | A PHASE IIB, DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED, PARALLEL GROUP TRIAL OF ANALGEZIA HCL FOR THE TREATMENT OF CHRONIC PAIN | XYZ123 | ADaM | 1.2 | http://www.cdisc.org/ns/odm/v1.2 util/adamres-draft2.xsd | define-v1-updated-html.xsl |
proc contents data=adm.EXTERNAL_LINKS;
run;The CONTENTS Procedure
| Data Set Name | ADM.EXTERNAL_LINKS | Observations | 6 |
|---|---|---|---|
| Member Type | DATA | Variables | 4 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 165 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 396 |
| Obs in First Data Page | 6 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/external_links.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1251 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 4 | D | Char | 1 | $1. | $1. | D |
| 1 | LeafID | Char | 17 | $17. | $17. | LeafID |
| 2 | LeafRelPath | Char | 130 | $130. | $130. | LeafRelPath |
| 3 | Title | Char | 17 | $17. | $17. | Title |
proc print data=adm.EXTERNAL_LINKS;
run;| Obs | LeafID | LeafRelPath | Title | D |
|---|---|---|---|---|
| 1 | SAP_Section_9.1.1 | ........\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr123123_csr.pdf#nameddest=SAP_SEC_9.1.1 | SAP Section 9.1.1 | |
| 2 | SAP_Section_9.2.1 | ........\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr123123_csr.pdf#nameddest=SAP_SEC_9.2.1 | SAP Section 9.2.1 | |
| 3 | SAP_Section_9.2.2 | ........\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr123123_csr.pdf#nameddest=SAP_SEC_9.2.2 | SAP Section 9.2.2 | |
| 4 | Table_14.1.1 | ........\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr123123_csr.pdf#page=302 | Table 14.1.1 | |
| 5 | Table_14.2.1 | ........\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr123123_csr.pdf#page=352 | Table 14.2.1 | |
| 6 | Figure_14.2.1 | ........\53-clin-stud-rep\535-rep-effic-safety-stud\5351-stud-rep-contr123123_csr.pdf#page=353 | Figure 14.2.1 |
proc contents data=adm.TOC_METADATA;
run;The CONTENTS Procedure
| Data Set Name | ADM.TOC_METADATA | Observations | 11 |
|---|---|---|---|
| Member Type | DATA | Variables | 11 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 178 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 367 |
| Obs in First Data Page | 11 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/toc_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1252 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 10 | ARCHIVELOCATIONID | Char | 7 | $7. | $7. | ARCHIVELOCATIONID |
| 9 | CLASS | Char | 4 | $4. | $4. | CLASS |
| 11 | DOCUMENTATION | Char | 34 | $34. | $34. | DOCUMENTATION |
| 8 | DOMAINKEYS | Char | 34 | $34. | $34. | DOMAINKEYS |
| 4 | ISREFERENCEDATA | Char | 2 | $2. | $2. | ISREFERENCEDATA |
| 6 | LABEL | Char | 37 | $37. | $37. | LABEL |
| 2 | NAME | Char | 5 | $5. | $5. | NAME |
| 1 | OID | Char | 5 | $5. | $5. | OID |
| 5 | PURPOSE | Char | 8 | $8. | $8. | PURPOSE |
| 3 | REPEATING | Char | 3 | $3. | $3. | REPEATING |
| 7 | STRUCTURE | Char | 39 | $39. | $39. | STRUCTURE |
proc print data=adm.TOC_METADATA;
run;| Obs | OID | NAME | REPEATING | ISREFERENCEDATA | PURPOSE | LABEL | STRUCTURE | DOMAINKEYS | CLASS | ARCHIVELOCATIONID | DOCUMENTATION |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADAE | ADAE | Yes | No | Analysis | Adverse Events Analysis Datasets | ADAE - One record per event per subject | STUDYID, USUBJID, AEDECOD, AESDT | ADAE | ./ADAE | Primarily derived from SDTM.AE |
| 2 | ADSL | ADSL | No | No | Analysis | Subject Level Analysis Dataset | ADSL - One record per subject | STUDYID, USUBJID | ADSL | ./ADSL | Derived from multiple SDTM domains |
| 3 | ADEF | ADEF | Yes | No | Analysis | Efficacy/Pain Scores Analysis Dataset | One record per subject per visit | STUDYID, USUBJID, PARAMCD, AVISITN | BDS | ./ADEF | Primarily derived from SDTM.XP |
| 4 | ADTTE | ADTTE | No | No | Analysis | Time-to-Pain Relief Analysis Dataset | One record per subject | STUDYID, USUBJID | BDS | ./ADTTE | Primarily derived from ADaM.ADAE |
| 5 | |||||||||||
| 6 | |||||||||||
| 7 | |||||||||||
| 8 | |||||||||||
| 9 | |||||||||||
| 10 | |||||||||||
| 11 |
proc contents data=adm.VALUELEVEL_METADATA;
run;The CONTENTS Procedure
| Data Set Name | ADM.VALUELEVEL_METADATA | Observations | 3 |
|---|---|---|---|
| Member Type | DATA | Variables | 14 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 105 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 623 |
| Obs in First Data Page | 3 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/valuelevel_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1253 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 11 | CODELISTNAME | Char | 11 | $11. | $11. | CODELISTNAME |
| 8 | COMMENT | Char | 27 | $27. | $27. | COMMENT |
| 10 | COMPUTATIONMETHODOID | Char | 9 | $9. | $9. | COMPUTATIONMETHODOID |
| 9 | DISPLAYFORMAT | Char | 4 | $4. | $4. | DISPLAYFORMAT |
| 5 | LABEL | Char | 10 | $10. | $10. | LABEL |
| 4 | LENGTH | Char | 2 | $2. | $2. | LENGTH |
| 12 | MANDATORY | Char | 2 | $2. | $2. | MANDATORY |
| 7 | ORIGIN | Char | 11 | $11. | $11. | ORIGIN |
| 13 | ROLE | Char | 1 | $1. | $1. | ROLE |
| 14 | ROLECODELIST | Char | 1 | $1. | $1. | ROLECODELIST |
| 6 | SIGNIFICANTDIGITS | Char | 1 | $1. | $1. | SIGNIFICANTDIGITS |
| 3 | TYPE | Char | 7 | $7. | $7. | TYPE |
| 1 | VALUELISTOID | Char | 13 | $13. | $13. | VALUELISTOID |
| 2 | VALUENAME | Char | 6 | $6. | $6. | VALUENAME |
proc print data=adm.VALUELEVEL_METADATA;
run;| Obs | VALUELISTOID | VALUENAME | TYPE | LENGTH | LABEL | SIGNIFICANTDIGITS | ORIGIN | COMMENT | DISPLAYFORMAT | COMPUTATIONMETHODOID | CODELISTNAME | MANDATORY | ROLE | ROLECODELIST |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | XPTESTCDVALUE | XPPAIN | integer | 8 | Pain Score | 1 | XP.XPSTRESN | 1. | PAINSCORE | No | ||||
| 2 | CRIT1VALUE | XPPAIN | char | 51 | Pain Score | Assignment per the codelist | $52. | CRIT1VALUES | No | |||||
| 3 | CRIT1FLVALUE | XPPAIN | char | 1 | Pain Score | $1. | RESPONDER | _0N1Y | No |
proc contents data=adm.VARIABLE_METADATA;
run;The CONTENTS Procedure
| Data Set Name | ADM.VARIABLE_METADATA | Observations | 128 |
|---|---|---|---|
| Member Type | DATA | Variables | 16 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:10:29 | Observation Length | 272 |
| Last Modified | 10/13/2019 22:10:29 | Deleted Observations | 0 |
| Protection | Compressed | NO | |
| Data Set Type | Sorted | NO | |
| Label | |||
| Data Representation | SOLARIS_X86_64, LINUX_X86_64, ALPHA_TRU64, LINUX_IA64 | ||
| Encoding | utf-8 Unicode (UTF-8) |
| Engine/Host Dependent Information | |
|---|---|
| Data Set Page Size | 65536 |
| Number of Data Set Pages | 1 |
| First Data Page | 1 |
| Max Obs per Page | 240 |
| Obs in First Data Page | 128 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/adam/variable_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1254 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 128KB |
| File Size (bytes) | 131072 |
| Alphabetic List of Variables and Attributes | ||||||
|---|---|---|---|---|---|---|
| # | Variable | Type | Len | Format | Informat | Label |
| 12 | CODELISTNAME | Char | 8 | $8. | $8. | CODELISTNAME |
| 9 | COMMENT | Char | 63 | $63. | $63. | COMMENT |
| 11 | COMPUTATIONMETHODOID | Char | 18 | $18. | $18. | COMPUTATIONMETHODOID |
| 10 | DISPLAYFORMAT | Char | 6 | $6. | $6. | DISPLAYFORMAT |
| 1 | DOMAIN | Char | 5 | $5. | $5. | DOMAIN |
| 6 | LABEL | Char | 37 | $37. | $37. | LABEL |
| 5 | LENGTH | Num | 8 | 15. | LENGTH | |
| 13 | MANDATORY | Char | 3 | $3. | $3. | MANDATORY |
| 8 | ORIGIN | Char | 56 | $56. | $56. | ORIGIN |
| 14 | ROLE | Char | 18 | $18. | $18. | ROLE |
| 15 | ROLECODELIST | Char | 8 | $8. | $8. | ROLECODELIST |
| 7 | SIGNIFICANTDIGITS | Char | 1 | $1. | $1. | SIGNIFICANTDIGITS |
| 4 | TYPE | Char | 7 | $7. | $7. | TYPE |
| 16 | VALUELISTOID | Char | 13 | $13. | $13. | VALUELISTOID |
| 3 | VARIABLE | Char | 8 | $8. | $8. | VARIABLE |
| 2 | VARNUM | Num | 8 | 15. | VARNUM | |
proc print data=adm.VARIABLE_METADATA (obs=101);
run;| Obs | DOMAIN | VARNUM | VARIABLE | TYPE | LENGTH | LABEL | SIGNIFICANTDIGITS | ORIGIN | COMMENT | DISPLAYFORMAT | COMPUTATIONMETHODOID | CODELISTNAME | MANDATORY | ROLE | ROLECODELIST | VALUELISTOID |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADSL | 1 | STUDYID | text | 15 | Study Identifier | DM | Yes | Identifier | ROLECODE | ||||||
| 2 | ADSL | 3 | USUBJID | text | 25 | Unique Subject Identifier | DM | Yes | Identifier | ROLECODE | ||||||
| 3 | ADSL | 4 | SUBJID | text | 7 | Subject Identifier for the Study | DM | Yes | Identifier | ROLECODE | ||||||
| 4 | ADSL | 7 | SITEID | text | 7 | Study Site Identifier | DM | Yes | Record Qualifier | ROLECODE | ||||||
| 5 | ADSL | 15 | COUNTRY | text | 3 | Country | Derived | COUNTRY | Yes | Record Qualifier | ROLECODE | |||||
| 6 | ADSL | 8 | BRTHDT | integer | 8 | Date of Birth | Derived | No | Record Qualifier | ROLECODE | ||||||
| 7 | ADSL | 9 | AGE | integer | 8 | Age | DM | 3.0 | Yes | Record Qualifier | ROLECODE | |||||
| 8 | ADSL | 10 | AGEU | text | 5 | Age Units | DM | AGEU | Yes | Variable Qualifier | ROLECODE | |||||
| 9 | ADSL | 10 | AGEGR1 | text | 40 | Pooled Age Group 1 | Derived | AGEGR1 | No | Record Qualifier | ROLECODE | |||||
| 10 | ADSL | 10 | AGEGR1N | integer | 8 | Pooled Age Group 1 (N) | Derived | AGEGR1N | No | Record Qualifier | ROLECODE | |||||
| 11 | ADSL | 11 | SEX | text | 1 | Sex | DM | SEX | Yes | Record Qualifier | ROLECODE | |||||
| 12 | ADSL | 12 | RACE | text | 40 | Race | DM | RACE | Yes | Record Qualifier | ROLECODE | |||||
| 13 | ADSL | 12 | RACEOTH | text | 40 | Race, Other, Specify | SUPPDM | No | Record Qualifier | ROLECODE | ||||||
| 14 | ADSL | 5 | RANDDT | integer | 8 | Date of Randomization | SUPPDM | No | Record Qualifier | ROLECODE | ||||||
| 15 | ADSL | 5 | TRTSDT | integer | 8 | Date of First Exposure to Treatment | Derived | Yes | Record Qualifier | ROLECODE | ||||||
| 16 | ADSL | 6 | TRTEDT | integer | 8 | Date of Last Exposure to Treatment | Derived | Yes | Record Qualifier | ROLECODE | ||||||
| 17 | ADSL | 13 | ARM | text | 40 | Description of Planned Arm | DM | ARM | Yes | Record Qualifier | ROLECODE | |||||
| 18 | ADSL | 13 | TRT01P | text | 40 | Planned Treatment for Period 01 | Derived | ARM | Yes | Record Qualifier | ROLECODE | |||||
| 19 | ADSL | 13 | TRT01A | text | 40 | Actual Treatment for Period 01 | Derived | ARM | Yes | Record Qualifier | ROLECODE | |||||
| 20 | ADSL | 13 | TRT01PN | integer | 8 | Planned Treatment for Period 01 (N) | Derived | ARMN | No | Record Qualifier | ROLECODE | |||||
| 21 | ADSL | 13 | TRT01AN | integer | 8 | Actual Treatment for Period 01 (N) | Derived | ARMN | No | Record Qualifier | ROLECODE | |||||
| 22 | ADSL | 15 | ITTFL | text | 1 | Intent-To-Treat Population Flag | Derived - randdt > . | _0N1Y | No | Record Qualifier | ROLECODE | |||||
| 23 | ADSL | 15 | SAFFL | text | 1 | Safety Population Flag | Derived - trtsdt > . | _0N1Y | No | Record Qualifier | ROLECODE | |||||
| 24 | ADSL | 15 | RESPFL | text | 1 | Efficacy Responder Flag | Derived - .z <= chg <= -2 | _0N1Y | No | Record Qualifier | ROLECODE | |||||
| 25 | ADEF | 1 | STUDYID | text | 15 | Study Identifier | ADSL.STUDYID | Yes | Identifier | ROLECODE | ||||||
| 26 | ADEF | 2 | USUBJID | text | 25 | Unique Subject Identifier | ADSL.USUBJID | Yes | Identifier | ROLECODE | ||||||
| 27 | ADEF | 7 | SITEID | text | 7 | Study Site Identifier | ADSL.SITEID | Yes | Record Qualifier | ROLECODE | ||||||
| 28 | ADEF | 15 | COUNTRY | text | 3 | Country | ADSL.COUNTRY | COUNTRY | Yes | Record Qualifier | ROLECODE | |||||
| 29 | ADEF | 5 | RANDDT | integer | 8 | Date of Randomization | ADSL.RANDDT | date9. | No | Record Qualifier | ROLECODE | |||||
| 30 | ADEF | 3 | AGE | integer | 8 | Age | ADSL.AGE | Yes | Identifier | ROLECODE | ||||||
| 31 | ADEF | 4 | AGEGR1N | integer | 8 | Pooled Age Group 1 (N) | ADSL.AGEGR1N | Yes | Identifier | ROLECODE | ||||||
| 32 | ADEF | 5 | AGEGR1 | text | 20 | Pooled Age Group 1 | ADSL.AGEGR1 | Yes | Topic | ROLECODE | ||||||
| 33 | ADEF | 6 | SEX | text | 1 | Sex | ADSL.SEX | Yes | Synonym Qualifier | ROLECODE | ||||||
| 34 | ADEF | 10 | TRTPN | integer | 8 | Planned Treatment (N) | ADSL.TRTPN | Yes | Timing | ROLECODE | ||||||
| 35 | ADEF | 11 | TRTP | text | 40 | Planned Treatment | ADSL.TRTP | No | Timing | ROLECODE | ||||||
| 36 | ADEF | 13 | PARAMCD | text | 8 | Parameter Code | Derived | Record Qualifier | ROLECODE | |||||||
| 37 | ADEF | 14 | PARAM | text | 40 | Parameter | Derived | Record Qualifier | ROLECODE | |||||||
| 38 | ADEF | 15 | AVISIT | text | 16 | Analysis Visit | Derived | VISIT | Record Qualifier | ROLECODE | ||||||
| 39 | ADEF | 16 | AVISITN | integer | 8 | Analysis Visit (N) | Derived | AVISITN | Record Qualifier | ROLECODE | ||||||
| 40 | ADEF | 17 | ABLFL | text | 1 | Baseline Record Flag | Derived | _0N1Y | Record Qualifier | ROLECODE | ||||||
| 41 | ADEF | 18 | XPSEQ | integer | 8 | Sequence Number | XP.XPSEQ | Record Qualifier | ROLECODE | |||||||
| 42 | ADEF | 19 | VISITNUM | integer | 8 | Visit Number | XP.VISITNUM | VISIT | Record Qualifier | ROLECODE | ||||||
| 43 | ADEF | 20 | ADT | integer | 8 | Analysis Date | Derived | date9. | Record Qualifier | ROLECODE | ||||||
| 44 | ADEF | 21 | ADY | integer | 8 | Analysis Relative Day | Derived | Record Qualifier | ROLECODE | |||||||
| 45 | ADEF | 22 | AVAL | integer | 8 | Analysis Value | XP.XPSTRESN | Record Qualifier | ROLECODE | XPTESTCDVALUE | ||||||
| 46 | ADEF | 23 | AVALC | text | 12 | Analysis Value (C) | XP.XPSTRES | Record Qualifier | ROLECODE | |||||||
| 47 | ADEF | 24 | BASE | integer | 8 | Baseline Value | Last non-missing valueof AVAL prior to first dose | Record Qualifier | ROLECODE | |||||||
| 48 | ADEF | 25 | CHG | integer | 8 | Change from Baseline | CHANGEFROMBASELINE | Record Qualifier | ROLECODE | |||||||
| 49 | ADEF | 27 | CRIT1FL | text | 1 | Criterion 1 Evaluation Result Flag | Click variable link for analysis parameter value level metadata | _0N1Y | Record Qualifier | ROLECODE | CRIT1FLVALUE | |||||
| 50 | ADEF | 28 | CRIT1 | text | 60 | Analysis Criterion 1 | Click variable link for analysis parameter value level metadata | Record Qualifier | ROLECODE | CRIT1VALUE | ||||||
| 51 | ADEF | 29 | ITTFL | text | 1 | Intent-to-Treat Flag | ADSL.ITTFL | _0N1Y | Record Qualifier | ROLECODE | ||||||
| 52 | ADAE | 1 | STUDYID | text | 15 | Study Identifier | ADSL.STUDYID | Yes | Identifier | ROLECODE | ||||||
| 53 | ADAE | 2 | USUBJID | text | 25 | Unique Subject Identifier | ADSL.USUBJID | Yes | Identifier | ROLECODE | ||||||
| 54 | ADAE | 3 | SITEID | text | 7 | Study Site Identifier | ADSL.SITEID | Yes | Record Qualifier | ROLECODE | ||||||
| 55 | ADAE | 4 | COUNTRY | text | 3 | Country | ADSL.COUNTRY | COUNTRY | Yes | Record Qualifier | ROLECODE | |||||
| 56 | ADAE | 5 | AESEQ | integer | 8 | Sequence Number | Derived | Yes | Identifier | ROLECODE | ||||||
| 57 | ADAE | 6 | AGE | integer | 8 | Unique Subject Identifier | ADSL | Yes | Identifier | ROLECODE | ||||||
| 58 | ADAE | 7 | AGEGR1N | integer | 8 | Pooled Age Group 1 (N) | ADSL | Yes | Identifier | ROLECODE | ||||||
| 59 | ADAE | 8 | AGEGR1 | text | 20 | Pooled Age Group 1 | ADSL | Yes | Topic | ROLECODE | ||||||
| 60 | ADAE | 9 | SEX | text | 1 | Sex | ADSL | Yes | Synonym Qualifier | ROLECODE | ||||||
| 61 | ADAE | 10 | TRTAN | integer | 8 | Actual Treatment (N) | ADSL | Yes | Timing | ROLECODE | ||||||
| 62 | ADAE | 11 | TRTA | text | 40 | Actual Treatment | ADSL | No | Timing | ROLECODE | ||||||
| 63 | ADAE | 12 | AETERM | text | 200 | Reported Term for the Adverse Event | AETERM | Yes | Topic | ROLECODE | ||||||
| 64 | ADAE | 13 | AEDECOD | text | 200 | Dictionary-Derived Term | AEDECOD | MedDRA | Yes | Synonym Qualifier | ROLECODE | |||||
| 65 | ADAE | 14 | AEBODSYS | text | 200 | Body System or Organ Class | AEBODSYS | MedDRA | Yes | Record Qualifier | ROLECODE | |||||
| 66 | ADAE | 15 | AESDT | integer | 8 | Start Date/Time of Adverse Events | AE.AESTDTC | Yes | Timing | ROLECODE | ||||||
| 67 | ADAE | 16 | AEEDT | integer | 8 | End Date/Time of Adverse Events | AE.AEENDTC | Yes | Timing | ROLECODE | ||||||
| 68 | ADAE | 17 | AESDY | integer | 8 | Study Day of Start of Adverse Event | Derived - AESTDTC - TRTSDT | No | Timing | ROLECODE | ||||||
| 69 | ADAE | 18 | AEEDY | integer | 8 | Study Day of End of Adverse Event | Derived - AEENDTC - TRTSDT | No | Timing | ROLECODE | ||||||
| 70 | ADAE | 16 | AESEV | text | 40 | Severity/Intensity | AESEV | No | Record Qualifier | ROLECODE | ||||||
| 71 | ADAE | 17 | AESEVN | integer | 8 | Severity/Intensity (N) | 0 | Derived | 1 | AESEVN | No | Record Qualifier | ROLECODE | |||
| 72 | ADAE | 18 | AESER | text | 40 | Serious Event | AESER | No | Record Qualifier | ROLECODE | ||||||
| 73 | ADAE | 19 | AEACN | text | 40 | Action Taken with Study Treatment | AEACN | No | Record Qualifier | ROLECODE | ||||||
| 74 | ADAE | 20 | AEREL | text | 40 | Causality | AEREL | No | Record Qualifier | ROLECODE | ||||||
| 75 | ADAE | 21 | AERELN | integer | 8 | Causality (N) | 0 | Derived | 1 | AERELN | No | Record Qualifier | ROLECODE | |||
| 76 | ADAE | 22 | CQ01NAM | text | 200 | CQ 01 Name | Derived - index(AEDECOD, ‘PAIN’)>0 or AEDECOD=‘HEADACHE’ | if non-null then PAIN EVENT | No | Record Qualifier | ROLECODE | |||||
| 77 | ADAE | 23 | RELGR1 | text | 10 | Pooled Causality Group 1 | Derived - AERELN | RELGR1 | No | Record Qualifier | ROLECODE | |||||
| 78 | ADAE | 24 | RELGR1N | integer | 8 | Pooled Causality Group 1 (N) | Derived | RELGR1N | No | Record Qualifier | ROLECODE | |||||
| 79 | ADAE | 25 | TRTEMFL | text | 1 | Treatment Emergent Flag | Derived - astdt >= trtsdt | EVNTDESC | No | Record Qualifier | ROLECODE | |||||
| 80 | ADAE | 15 | SAFFL | text | 1 | Safety Population Flag | ADSL | _0N1Y | No | Record Qualifier | ROLECODE | |||||
| 81 | ADTTE | 1 | STUDYID | text | 15 | Study Identifier | ADSL | Yes | Identifier | ROLECODE | ||||||
| 82 | ADTTE | 2 | USUBJID | text | 25 | Domain Abbreviation | ADSL | Yes | Identifier | ROLECODE | ||||||
| 83 | ADTTE | 7 | SITEID | text | 7 | Study Site Identifier | ADSL | Yes | Record Qualifier | ROLECODE | ||||||
| 84 | ADTTE | 15 | COUNTRY | text | 3 | Country | ADSL | COUNTRY | Yes | Record Qualifier | ROLECODE | |||||
| 85 | ADTTE | 3 | AGE | integer | 8 | Unique Subject Identifier | ADSL | Yes | Identifier | ROLECODE | ||||||
| 86 | ADTTE | 4 | AGEGR1N | integer | 8 | Pooled Age Group 1 (N) | ADSL | Yes | Identifier | ROLECODE | ||||||
| 87 | ADTTE | 5 | AGEGR1 | text | 20 | Pooled Age Group 1 | ADSL | Yes | Topic | ROLECODE | ||||||
| 88 | ADTTE | 6 | SEX | text | 1 | Sex | ADSL | Yes | Synonym Qualifier | ROLECODE | ||||||
| 89 | ADTTE | 10 | TRTPN | integer | 8 | Planned Treatment (N) | ADSL | Yes | Timing | ROLECODE | ||||||
| 90 | ADTTE | 11 | TRTP | text | 40 | Planned Treatment | ADSL | No | Timing | ROLECODE | ||||||
| 91 | ADTTE | 13 | PARAMCD | text | 8 | Parameter Code | Derived | No | Record Qualifier | ROLECODE | XPTESTCD | |||||
| 92 | ADTTE | 14 | PARAM | text | 40 | Parameter | Derived | No | Record Qualifier | ROLECODE | ||||||
| 93 | ADTTE | 20 | ADT | integer | 8 | Analysis Date | Derived | No | Record Qualifier | ROLECODE | ||||||
| 94 | ADTTE | 22 | AVAL | integer | 8 | Analysis Value | Data From XP | No | Record Qualifier | ROLECODE | ||||||
| 95 | ADTTE | 23 | STARTDT | integer | 8 | Time to Event Origin Date for Subject | ADSL.RANDDT | No | Record Qualifier | ROLECODE | ||||||
| 96 | ADTTE | 24 | CNSR | integer | 8 | Censor | Derived | CENSOR | Yes | Record Qualifier | ROLECODE | |||||
| 97 | ADTTE | 25 | EVNTDESC | text | 40 | Event or Censoring Description | Derived | EVNTDESC | Yes | Record Qualifier | ROLECODE | |||||
| 98 | ADTTE | 26 | SRCDOM | text | 6 | Source Domain | Derived | No | Record Qualifier | ROLECODE | ||||||
| 99 | ADTTE | 27 | SRCVAR | text | 8 | Source Variable | Derived | No | Record Qualifier | ROLECODE | ||||||
| 100 | ADTTE | 28 | SRCSEQ | integer | 8 | Source Sequence Number | Derived | No | Record Qualifier | ROLECODE | ||||||
| 101 | ADTTE | 29 | ITTFL | text | 1 | Intent-to-Treat Flag | ADSL.ITTFL |