%let path=/folders/myfolders/cdisc_ucsd;
libname dtm "&path/sdtm";<!DOCTYPE html PUBLIC “-//W3C//DTD HTML 4.01//EN” “http://www.w3.org/TR/html4/strict.dtd”>
44 ods listing close;ods html5 (id=saspy_internal) file=stdout options(bitmap_mode='inline') device=svg style=HTMLBlue; ods
44 ! graphics on / outputfmt=png;
NOTE: Writing HTML5(SASPY_INTERNAL) Body file: STDOUT
45
46 %let path=/folders/myfolders/cdisc_ucsd;
47
48 libname dtm "&path/sdtm";
NOTE: Libref DTM was successfully assigned as follows:
Engine: V9
Physical Name: /folders/myfolders/cdisc_ucsd/sdtm
49
50 ods html5 (id=saspy_internal) close;ods listing;
51
%macro import_sdtm_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 dtm.&&sheet&i;
set myexcel."&&sheet&i"n;
run;
%end;
libname myexcel clear;
%mend import_sdtm_xls;<!DOCTYPE html PUBLIC “-//W3C//DTD HTML 4.01//EN” “http://www.w3.org/TR/html4/strict.dtd”>
865 ods listing close;ods html5 (id=saspy_internal) file=stdout options(bitmap_mode='inline') device=svg style=HTMLBlue; ods
865! graphics on / outputfmt=png;
NOTE: Writing HTML5(SASPY_INTERNAL) Body file: STDOUT
866
867 %macro import_sdtm_xls(excel);
868 options nostimer;
869 libname myexcel xlsx "&excel";
870
871 proc sql noprint;
872 select memname into :sheet1-
873 from dictionary.tables
874 where libname="MYEXCEL";
875 quit;
876
877 %do i=1 %to &sqlobs;
878 data dtm.&&sheet&i;
879 set myexcel."&&sheet&i"n;
880 run;
881 %end;
882
883 libname myexcel clear;
884
885 %mend import_sdtm_xls;
886
887 ods html5 (id=saspy_internal) close;ods listing;
888
%import_sdtm_xls(&path/sdtm_metadata.xlsx); <!DOCTYPE html PUBLIC “-//W3C//DTD HTML 4.01//EN” “http://www.w3.org/TR/html4/strict.dtd”>
890 ods listing close;ods html5 (id=saspy_internal) file=stdout options(bitmap_mode='inline') device=svg style=HTMLBlue; ods
890! graphics on / outputfmt=png;
NOTE: Writing HTML5(SASPY_INTERNAL) Body file: STDOUT
891
892 %import_sdtm_xls(&path/sdtm_metadata.xlsx);
NOTE: Libref MYEXCEL was successfully assigned as follows:
Engine: XLSX
Physical Name: /folders/myfolders/cdisc_ucsd/sdtm_metadata.xlsx
NOTE: The import data set has 138 observations and 11 variables.
NOTE: There were 138 observations read from the data set MYEXCEL.CODELISTS.
NOTE: The data set DTM.CODELISTS has 138 observations and 11 variables.
NOTE: The import data set has 1 observations and 2 variables.
NOTE: There were 1 observations read from the data set MYEXCEL.COMPUTATION_METHOD.
NOTE: The data set DTM.COMPUTATION_METHOD has 1 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 DTM.DEFINE_HEADER_METADATA has 1 observations and 9 variables.
NOTE: The import data set has 11 observations and 10 variables.
NOTE: There were 11 observations read from the data set MYEXCEL.TOC_METADATA.
NOTE: The data set DTM.TOC_METADATA has 11 observations and 10 variables.
NOTE: The import data set has 10 observations and 15 variables.
NOTE: There were 10 observations read from the data set MYEXCEL.VALUELEVEL_METADATA.
NOTE: The data set DTM.VALUELEVEL_METADATA has 10 observations and 15 variables.
NOTE: The import data set has 127 observations and 16 variables.
NOTE: There were 127 observations read from the data set MYEXCEL.VARIABLE_METADATA.
NOTE: The data set DTM.VARIABLE_METADATA has 127 observations and 16 variables.
NOTE: Libref MYEXCEL has been deassigned.
893
894 ods html5 (id=saspy_internal) close;ods listing;
895
proc datasets lib=dtm;
run;
quit;
| Directory | |
|---|---|
| Libref | DTM |
| Engine | V9 |
| Physical Name | /folders/myfolders/cdisc_ucsd/sdtm |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm |
| Inode Number | 1227 |
| Access Permission | rwxrwx— |
| Owner Name | root |
| File Size | 4KB |
| File Size (bytes) | 4096 |
| # | Name | Member Type | File Size | Last Modified |
|---|---|---|---|---|
| 1 | CODELISTS | DATA | 128KB | 10/13/2019 22:44:14 |
| 2 | COMPUTATION_METHOD | DATA | 128KB | 10/13/2019 22:44:14 |
| 3 | DEFINE_HEADER_METADATA | DATA | 128KB | 10/13/2019 22:44:14 |
| 4 | TOC_METADATA | DATA | 128KB | 10/13/2019 22:44:14 |
| 5 | VALUELEVEL_METADATA | DATA | 128KB | 10/13/2019 22:44:14 |
| 6 | VARIABLE_METADATA | DATA | 128KB | 10/13/2019 22:44:14 |
proc contents data=dtm.codelists;
run;The CONTENTS Procedure
| Data Set Name | DTM.CODELISTS | Observations | 138 |
|---|---|---|---|
| Member Type | DATA | Variables | 11 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:44:14 | Observation Length | 160 |
| Last Modified | 10/13/2019 22:44:14 | 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 | 409 |
| Obs in First Data Page | 138 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm/codelists.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1922 |
| 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 | 36 | $36. | $36. | CODEDVALUE |
| 6 | CODELISTDICTIONARY | Char | 6 | $6. | $6. | CODELISTDICTIONARY |
| 1 | CODELISTNAME | Char | 8 | $8. | $8. | CODELISTNAME |
| 7 | CODELISTVERSION | Char | 3 | $3. | $3. | CODELISTVERSION |
| 2 | RANK | Num | 8 | BEST. | RANK | |
| 4 | TRANSLATED | Char | 46 | $46. | $46. | TRANSLATED |
| 5 | TYPE | Char | 4 | $4. | $4. | TYPE |
| 8 | sourcedataset | Char | 11 | $11. | $11. | sourcedataset |
| 11 | sourcetype | Char | 9 | $9. | $9. | sourcetype |
| 10 | sourcevalue | Char | 16 | $16. | $16. | sourcevalue |
| 9 | sourcevariable | Char | 8 | $8. | $8. | sourcevariable |
proc print data=dtm.codelists;
run;| Obs | CODELISTNAME | RANK | CODEDVALUE | TRANSLATED | TYPE | CODELISTDICTIONARY | CODELISTVERSION | sourcedataset | sourcevariable | sourcevalue | sourcetype |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACN | 1 | DOSE INCREASED | DOSE INCREASED | TEXT | adverse | aeaction | 3 | number | ||
| 2 | ACN | 2 | DOSE NOT CHANGED | DOSE NOT CHANGED | TEXT | adverse | aeaction | 4 | number | ||
| 3 | ACN | 3 | DOSE REDUCED | DOSE REDUCED | TEXT | adverse | aeaction | 2 | number | ||
| 4 | ACN | 4 | DRUG INTERRUPTED | DRUG INTERRUPTED | TEXT | adverse | aeaction | 1 | number | ||
| 5 | ACN | 5 | DRUG WITHDRAWN | DRUG WITHDRAWN | TEXT | adverse | aeaction | number | |||
| 6 | ACN | 6 | NOT APPLICABLE | NA | TEXT | adverse | aeaction | number | |||
| 7 | ACN | 7 | UNKNOWN | U; Unknown | TEXT | adverse | aeaction | 5 | number | ||
| 8 | AEBODSYS | 1 | TEXT | MedDRA | 7.0 | ||||||
| 9 | AEDECOD | 1 | TEXT | MedDRA | 7.0 | ||||||
| 10 | AEREL | 1 | NOT RELATED | NOT RELATED | TEXT | adverse | aerel | 1 | number | ||
| 11 | AEREL | 2 | POSSIBLY RELATED | POSSIBLY RELATED | TEXT | adverse | aerel | 2 | number | ||
| 12 | AEREL | 3 | PROBABLY RELATED | PROBABLY RELATED | TEXT | adverse | aerel | 3 | number | ||
| 13 | NAEREL | 1 | 1 | NOT RELATED | TEXT | adverse | aerel | NOT RELATED | character | ||
| 14 | NAEREL | 2 | 2 | POSSIBLY RELATED | TEXT | adverse | aerel | POSSIBLY RELATED | character | ||
| 15 | NAEREL | 3 | 3 | PROBABLY RELATED | TEXT | adverse | aerel | PROBABLY RELATED | character | ||
| 16 | AESEV | 1 | MILD | Grade 1; 1 | TEXT | adverse | aesev | 1 | number | ||
| 17 | AESEV | 2 | MODERATE | Grade 2; 2 | TEXT | adverse | aesev | 2 | number | ||
| 18 | AESEV | 3 | SEVERE | Grade 3; 3 | TEXT | adverse | aesev | 3 | number | ||
| 19 | AGEU | 1 | YEARS | YEARS | TEXT | NONE | |||||
| 20 | ARM | 1 | Analgezia HCL 30 mg | Analgezia HCL 30 mg | TEXT | demographic | trt | 1 | number | ||
| 21 | ARM | 2 | Placebo | Placebo | TEXT | demographic | trt | 0 | number | ||
| 22 | ARMCD | 1 | ALG123 | Analgezia HCL 30 mg | TEXT | demographic | trt | 1 | number | ||
| 23 | ARMCD | 2 | PLACEBO | Placebo | TEXT | demographic | trt | 0 | number | ||
| 24 | COUNTRY | 1 | USA | UNITED STATES | TEXT | NONE | |||||
| 25 | FRM | 1 | TABLET, COATED | TABLET, COATED | TEXT | ||||||
| 26 | IECAT | 1 | INCLUSION | INCLUSION | TEXT | ||||||
| 27 | IECAT | 2 | EXCLUSION | EXCLUSION | TEXT | ||||||
| 28 | LBCAT | 1 | CHEMISTRY | CHEMISTRY | TEXT | labs | labcat | CHEMISTRY | character | ||
| 29 | LBCAT | 2 | HEMATOLOGY | HEMATOLOGY | TEXT | labs | labcat | HEMATOLOGY | character | ||
| 30 | LBNRIND | 1 | HIGH | HIGH | TEXT | ||||||
| 31 | LBNRIND | 2 | LOW | LOW | TEXT | ||||||
| 32 | LBNRIND | 3 | NORMAL | NORMAL | TEXT | ||||||
| 33 | LBTEST | 1 | Alanine Aminotransferase; SGPT | Alanine Aminotransferase; SGPT | TEXT | labs | labtest | ALT (SGPT) | character | ||
| 34 | LBTEST | 2 | Albumin; Microalbumin | Albumin; Microalbumin | TEXT | labs | labtest | ALBUMIN | character | ||
| 35 | LBTEST | 3 | Alkaline Phosphatase | Alkaline Phosphatase | TEXT | labs | labtest | ALK. PHOS. | character | ||
| 36 | LBTEST | 4 | Aspartate Aminotransferase; SGOT | Aspartate Aminotransferase; SGOT | TEXT | labs | labtest | AST (SGOT) | character | ||
| 37 | LBTEST | 5 | Bilirubin; Total Bilirubin | Bilirubin; Total Bilirubin | TEXT | labs | labtest | TOTAL BILI | character | ||
| 38 | LBTEST | 6 | Direct Bilirubin | Direct Bilirubin | TEXT | labs | labtest | DIRECT BILI | character | ||
| 39 | LBTEST | 7 | Gamma Glutamyl Transferase | Gamma Glutamyl Transferase | TEXT | labs | labtest | GGTP | character | ||
| 40 | LBTEST | 8 | Hematocrit | Hematocrit | TEXT | labs | labtest | HEMATOCRIT | character | ||
| 41 | LBTEST | 9 | Hemoglobin | Hemoglobin | TEXT | labs | labtest | HEMOGLOBIN | character | ||
| 42 | LBTEST | 10 | Protein | Protein | TEXT | labs | labtest | TOTAL PROT | character | ||
| 43 | LBTESTCD | 1 | ALB | Albumin; Microalbumin | TEXT | labs | labtest | ALBUMIN | character | ||
| 44 | LBTESTCD | 2 | ALP | Alkaline Phosphatase | TEXT | labs | labtest | ALK. PHOS. | character | ||
| 45 | LBTESTCD | 3 | ALT | Alanine Aminotransferase; SGPT | TEXT | labs | labtest | ALT (SGPT) | character | ||
| 46 | LBTESTCD | 4 | AST | Aspartate Aminotransferase; SGOT | TEXT | labs | labtest | AST (SGOT) | character | ||
| 47 | LBTESTCD | 5 | BILDIR | Direct Bilirubin | TEXT | labs | labtest | DIRECT BILI | character | ||
| 48 | LBTESTCD | 6 | BILI | Bilirubin; Total Bilirubin | TEXT | labs | labtest | TOTAL BILI | character | ||
| 49 | LBTESTCD | 7 | GGT | Gamma Glutamyl Transferase | TEXT | labs | labtest | GGTP | character | ||
| 50 | LBTESTCD | 8 | HCT | Hematocrit | TEXT | labs | labtest | HEMATOCRIT | character | ||
| 51 | LBTESTCD | 9 | HGB | Hemoglobin | TEXT | labs | labtest | HEMOGLOBIN | character | ||
| 52 | LBTESTCD | 10 | PROT | Protein | TEXT | labs | labtest | TOTAL PROT | character | ||
| 53 | NY | 1 | N | No | TEXT | adverse | serious | NO | character | ||
| 54 | NY | 2 | NA | NA | TEXT | adverse | serious | character | |||
| 55 | NY | 3 | U | U; Unknown | TEXT | adverse | serious | character | |||
| 56 | NY | 4 | Y | Yes | TEXT | adverse | serious | character | |||
| 57 | RACE | 1 | BLACK OR AFRICAN AMERICAN | BLACK OR AFRICAN AMERICAN | TEXT | demographic | race | 2 | number | ||
| 58 | RACE | 2 | OTHER | OTHER | TEXT | demographic | race | 3 | number | ||
| 59 | RACE | 3 | WHITE | WHITE | TEXT | demographic | race | 1 | number | ||
| 60 | ROLECODE | 1 | Grouping Qualifier | Grouping Qualifier | TEXT | ||||||
| 61 | ROLECODE | 2 | Identifier | Identifier | TEXT | ||||||
| 62 | ROLECODE | 3 | Record Qualifier | Record Qualifier | TEXT | ||||||
| 63 | ROLECODE | 4 | Rule | Rule | TEXT | ||||||
| 64 | ROLECODE | 5 | Result Qualifier | Result Qualifier | TEXT | ||||||
| 65 | ROLECODE | 6 | Synonym Qualifier | Synonym Qualifier | TEXT | ||||||
| 66 | ROLECODE | 7 | Timing | Timing | TEXT | ||||||
| 67 | ROLECODE | 8 | Topic | Topic | TEXT | ||||||
| 68 | SEX | 1 | F | FEMALE | TEXT | demographic | gender | 2 | number | ||
| 69 | SEX | 2 | M | MALE | TEXT | demographic | gender | 1 | number | ||
| 70 | SEX | 3 | U | UNKNOWN | TEXT | demographic | gender | . | number | ||
| 71 | TSPARM | 1 | Added on to Existing Treatments | Added on to Existing Treatments | TEXT | ||||||
| 72 | TSPARM | 2 | Planned Maximum Age of Subjects | Planned Maximum Age of Subjects | TEXT | ||||||
| 73 | TSPARM | 3 | Planned Minimum Age of Subjects | Planned Minimum Age of Subjects | TEXT | ||||||
| 74 | TSPARM | 4 | Age Group | Age Group | TEXT | ||||||
| 75 | TSPARM | 5 | Age Unit | Age Unit | TEXT | ||||||
| 76 | TSPARM | 6 | Dose per Administration | Dose per Administration | TEXT | ||||||
| 77 | TSPARM | 7 | Trial Length | Trial Length | TEXT | ||||||
| 78 | TSPARM | 8 | Planned Number of Subjects | Planned Number of Subjects | TEXT | ||||||
| 79 | TSPARM | 9 | Trial is Randomized | Trial is Randomized | TEXT | ||||||
| 80 | TSPARM | 10 | Route of Administration | Route of Administration | TEXT | ||||||
| 81 | TSPARM | 11 | Sex of Participants | Sex of Participants | TEXT | ||||||
| 82 | TSPARM | 12 | Study Stop Rules | Study Stop Rules | TEXT | ||||||
| 83 | TSPARM | 13 | Trial Blinding Schema | Trial Blinding Schema | TEXT | ||||||
| 84 | TSPARM | 14 | Control Type | Control Type | TEXT | ||||||
| 85 | TSPARM | 15 | Diagnosis Group | Diagnosis Group | TEXT | ||||||
| 86 | TSPARM | 16 | Trial Indication Type | Trial Indication Type | TEXT | ||||||
| 87 | TSPARM | 17 | Trial Title | Trial Title | TEXT | ||||||
| 88 | TSPARM | 18 | Trial Phase Classification | Trial Phase Classification | TEXT | ||||||
| 89 | TSPARM | 19 | Trial Type | Trial Type | TEXT | ||||||
| 90 | TSPARM | 20 | Current Therapy or Treatment | Current Therapy or Treatment | TEXT | ||||||
| 91 | TSPARM | 21 | Trial Primary Objective | Trial Primary Objective | TEXT | ||||||
| 92 | TSPARM | 22 | Trial Secondary Objective | Trial Secondary Objective | TEXT | ||||||
| 93 | TSPARM | 23 | Clinical Study Sponsor | Clinical Study Sponsor; Study Sponsor; Sponsor | TEXT | ||||||
| 94 | TSPARM | 24 | Comparative Treatment Name | Comparative Treatment Name | TEXT | ||||||
| 95 | TSPARM | 25 | Dose Units | Dose Units | TEXT | ||||||
| 96 | TSPARM | 26 | Dosing Frequency | Dosing Frequency | TEXT | ||||||
| 97 | TSPARM | 27 | Trial Indication | Trial Indication | TEXT | ||||||
| 98 | TSPARM | 28 | Investigational Therapy or Treatment | Investigational Therapy or Treatment | TEXT | ||||||
| 99 | TSPARM | 29 | Ratio for Randomization | Ratio for Randomization | TEXT | ||||||
| 100 | TSPARM | 30 | Stratification for Randomization | Stratification for Randomization | TEXT | ||||||
| 101 | TSPARMCD | 1 | ADDON | Added on to Existing Treatments | TEXT | ||||||
| 102 | TSPARMCD | 2 | AGEMAX | Planned Maximum Age of Subjects | TEXT | ||||||
| 103 | TSPARMCD | 3 | AGEMIN | Planned Minimum Age of Subjects | TEXT | ||||||
| 104 | TSPARMCD | 4 | AGESPAN | Age Span | TEXT | ||||||
| 105 | TSPARMCD | 5 | AGEU | Age Unit | TEXT | ||||||
| 106 | TSPARMCD | 6 | DOSE | Dose per Administration | TEXT | ||||||
| 107 | TSPARMCD | 7 | LENGTH | Trial Length | TEXT | ||||||
| 108 | TSPARMCD | 8 | PLANSUB | Planned Number of Subjects | TEXT | ||||||
| 109 | TSPARMCD | 9 | RANDOM | Trial is Randomized | TEXT | ||||||
| 110 | TSPARMCD | 10 | ROUTE | Route of Administration | TEXT | ||||||
| 111 | TSPARMCD | 11 | SEXPOP | Sex of Participants | TEXT | ||||||
| 112 | TSPARMCD | 12 | STOPRULE | Study Stop Rules | TEXT | ||||||
| 113 | TSPARMCD | 13 | TBLIND | Trial Blinding Schema | TEXT | ||||||
| 114 | TSPARMCD | 14 | TCNTRL | Control Type | TEXT | ||||||
| 115 | TSPARMCD | 15 | TDIGRP | Diagnosis Group | TEXT | ||||||
| 116 | TSPARMCD | 16 | TINDTP | Trial Indication Type | TEXT | ||||||
| 117 | TSPARMCD | 17 | TITLE | Trial Title | TEXT | ||||||
| 118 | TSPARMCD | 18 | TPHASE | Trial Phase Classification | TEXT | ||||||
| 119 | TSPARMCD | 19 | TTYPE | Trial Type | TEXT | ||||||
| 120 | TSPARMCD | 20 | CURTRT | Current Therapy or Treatment | TEXT | ||||||
| 121 | TSPARMCD | 21 | OBJPRIM | Trial Primary Objective | TEXT | ||||||
| 122 | TSPARMCD | 22 | OBJSEC | Trial Secondary Objective | TEXT | ||||||
| 123 | TSPARMCD | 23 | SPONSOR | Clinical Study Sponsor; Study Sponsor; Sponsor | TEXT | ||||||
| 124 | TSPARMCD | 24 | COMPTRT | Comparative Treatment Name | TEXT | ||||||
| 125 | TSPARMCD | 25 | DOSU | Dose Units | TEXT | ||||||
| 126 | TSPARMCD | 26 | DOSFRQ | Dosing Frequency | TEXT | ||||||
| 127 | TSPARMCD | 27 | INDIC | Trial Indication | TEXT | ||||||
| 128 | TSPARMCD | 28 | TRT | Investigational Therapy or Treatment | TEXT | ||||||
| 129 | TSPARMCD | 29 | RANDRAT | Ratio for Randomization | TEXT | ||||||
| 130 | TSPARM | 30 | RANDSTR | Stratification for Randomization | TEXT | ||||||
| 131 | UNIT | 1 | % | Percentage | TEXT | labs | colunits | % | character | ||
| 132 | UNIT | 2 | g/dL | Gram per Deciliter | TEXT | labs | colunits | g/dL | character | ||
| 133 | UNIT | 3 | IU/L | International Unit per Liter | TEXT | labs | colunits | IU/L | character | ||
| 134 | UNIT | 4 | mg/dL | Milligram per Deciliter | TEXT | labs | colunits | mg/dL | character | ||
| 135 | UNIT | 5 | mg | Milligram | TEXT | ||||||
| 136 | VISIT | 1 | Baseline | Baseline | TEXT | labs | month | 0 | number | ||
| 137 | VISIT | 2 | 3 Months | Month 3 | TEXT | labs | month | 1 | number | ||
| 138 | VISIT | 3 | 6 Months | Month 6 | TEXT | labs | month | 2 | number |
proc contents data=dtm.computation_method;
run;The CONTENTS Procedure
| Data Set Name | DTM.COMPUTATION_METHOD | Observations | 1 |
|---|---|---|---|
| Member Type | DATA | Variables | 2 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:44:14 | Observation Length | 101 |
| Last Modified | 10/13/2019 22:44:14 | 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 | 647 |
| Obs in First Data Page | 1 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm/computation_method.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1924 |
| 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 | 87 | $87. | $87. | COMPUTATIONMETHOD |
| 1 | COMPUTATIONMETHODOID | Char | 14 | $14. | $14. | COMPUTATIONMETHODOID |
proc print data=dtm.computation_method;
run;| Obs | COMPUTATIONMETHODOID | COMPUTATIONMETHOD |
|---|---|---|
| 1 | AGECALCULATION | floor ((intck(‘month’, dob, firstdose) - (day(firstdose) < day(dob))) / 12) |
proc contents data=dtm.DEFINE_HEADER_METADATA;
run;The CONTENTS Procedure
| Data Set Name | DTM.DEFINE_HEADER_METADATA | Observations | 1 |
|---|---|---|---|
| Member Type | DATA | Variables | 9 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:44:15 | Observation Length | 232 |
| Last Modified | 10/13/2019 22:44:15 | 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 | 282 |
| Obs in First Data Page | 1 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm/define_header_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1925 |
| 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 | 48 | $48. | $48. | 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 | 15 | $15. | $15. | STYLESHEET |
| 7 | VERSION | Char | 5 | $5. | $5. | VERSION |
proc print data=dtm.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 | SDTM | 3.1.2 | http://www.cdisc.org/ns/odm/v1.2 define1-0-0.xsd | define1-0-0.xsl |
proc contents data=dtm.TOC_METADATA;
run;The CONTENTS Procedure
| Data Set Name | DTM.TOC_METADATA | Observations | 11 |
|---|---|---|---|
| Member Type | DATA | Variables | 10 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:44:15 | Observation Length | 193 |
| Last Modified | 10/13/2019 22:44:15 | 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 | 339 |
| Obs in First Data Page | 11 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm/toc_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1926 |
| 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 | 8 | $8. | $8. | ARCHIVELOCATIONID |
| 9 | CLASS | Char | 22 | $22. | $22. | CLASS |
| 8 | DOMAINKEYS | Char | 48 | $48. | $48. | DOMAINKEYS |
| 4 | ISREFERENCEDATA | Char | 3 | $3. | $3. | ISREFERENCEDATA |
| 6 | LABEL | Char | 34 | $34. | $34. | LABEL |
| 2 | NAME | Char | 6 | $6. | $6. | NAME |
| 1 | OID | Char | 6 | $6. | $6. | OID |
| 5 | PURPOSE | Char | 12 | $12. | $12. | PURPOSE |
| 3 | REPEATING | Char | 3 | $3. | $3. | REPEATING |
| 7 | STRUCTURE | Char | 51 | $51. | $51. | STRUCTURE |
proc PRINT data=dtm.TOC_METADATA;
run;| Obs | OID | NAME | REPEATING | ISREFERENCEDATA | PURPOSE | LABEL | STRUCTURE | DOMAINKEYS | CLASS | ARCHIVELOCATIONID |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AE | AE | Yes | No | Tabulation | Adverse Events | Events - One record per event per subject | STUDYID, USUBJID, AEDECOD, AESTDTC | Events | ./ae |
| 2 | DM | DM | No | No | Tabulation | Demographics | Special Purpose - One record per event per subject | STUDYID, USUBJID | Special Purpose | ./dm |
| 3 | EX | EX | Yes | No | Tabulation | Exposure | One record per constant dosing interval per subject | STUDYID, USUBJID, EXTRT, EXSTDTC | Interventions | ./ex |
| 4 | LB | LB | Yes | No | Tabulation | Laboratory Tests | Findings - One record per lab test per subject | STUDYID, USUBJID, LBCAT, LBTESTCD, VISITNUM | Findings | ./lb |
| 5 | XP | XP | Yes | No | Tabulation | Pain Scores | One record per subject per visit | STUDYID, USUBJID, XPTESTCD, VISITNUM | Findings | ./xp |
| 6 | TA | TA | Yes | Yes | Tabulation | Trial Arms | One record per planned Element per Arm | STUDYID, ARMCD, TAETORD | Trial Design | ./ta |
| 7 | TE | TE | Yes | Yes | Tabulation | Trial Elements | One record per planned Element | STUDYID, ETCD | Trial Design | ./te |
| 8 | TI | TI | Yes | Yes | Tabulation | Trial Inclusion/Exclusion Criteria | One record per I/E criterion | STUDYID, IETESTCD | Trial Design | ./ti |
| 9 | TS | TS | Yes | Yes | Tabulation | Trial Summary | One record per trial summary parameter value | STUDYID, TSSEQ | Trial Design | ./ts |
| 10 | TV | TV | Yes | Yes | Tabulation | Trial Visits | One record per planned Visit per Arm | STUDYID, VISITNUM, ARMCD | Trial Design | ./tv |
| 11 | SUPPDM | SUPPDM | Yes | No | Tabulation | DM - Supplemental Qualifiers | Supplemental Qualifier - One record per qualifier | STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM | Supplemental Qualifier | ./suppdm |
proc contents data=dtm.VALUELEVEL_METADATA;
run;The CONTENTS Procedure
| Data Set Name | DTM.VALUELEVEL_METADATA | Observations | 10 |
|---|---|---|---|
| Member Type | DATA | Variables | 15 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:44:15 | Observation Length | 96 |
| Last Modified | 10/13/2019 22:44:15 | 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 | 681 |
| Obs in First Data Page | 10 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm/valuelevel_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1927 |
| 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 | 1 | $1. | $1. | CODELISTNAME |
| 8 | COMMENT | Char | 1 | $1. | $1. | COMMENT |
| 10 | COMPUTATIONMETHODOID | Char | 1 | $1. | $1. | COMPUTATIONMETHODOID |
| 9 | DISPLAYFORMAT | Char | 3 | $3. | $3. | DISPLAYFORMAT |
| 5 | LABEL | Char | 32 | $32. | $32. | LABEL |
| 4 | LENGTH | Num | 8 | BEST. | LENGTH | |
| 12 | MANDATORY | Char | 2 | $2. | $2. | MANDATORY |
| 15 | O | Char | 1 | $1. | $1. | O |
| 7 | ORIGIN | Char | 18 | $18. | $18. | 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 | 5 | $5. | $5. | TYPE |
| 1 | VALUELISTOID | Char | 13 | $13. | $13. | VALUELISTOID |
| 2 | VALUENAME | Char | 6 | $6. | $6. | VALUENAME |
proc PRINT data=dtm.VALUELEVEL_METADATA;
run;| Obs | VALUELISTOID | VALUENAME | TYPE | LENGTH | LABEL | SIGNIFICANTDIGITS | ORIGIN | COMMENT | DISPLAYFORMAT | COMPUTATIONMETHODOID | CODELISTNAME | MANDATORY | ROLE | ROLECODELIST | O |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LBTESTCDVALUE | ALB | float | 8 | Albumin; Microalbumin | 1 | Central laboratory | 4.2 | No | ||||||
| 2 | LBTESTCDVALUE | ALP | float | 8 | Alkaline Phosphatase | Central laboratory | 3. | No | |||||||
| 3 | LBTESTCDVALUE | ALT | float | 8 | Alanine Aminotransferase; SGPT | Central laboratory | 3. | No | |||||||
| 4 | LBTESTCDVALUE | AST | float | 8 | Aspartate Aminotransferase; SGOT | Central laboratory | 3. | No | |||||||
| 5 | LBTESTCDVALUE | BILDIR | float | 8 | Direct Bilirubin | 1 | Central laboratory | 4.2 | No | ||||||
| 6 | LBTESTCDVALUE | BILI | float | 8 | Bilirubin; Total Bilirubin | 1 | Central laboratory | 4.2 | No | ||||||
| 7 | LBTESTCDVALUE | GGT | float | 8 | Gamma Glutamyl Transferase | Central laboratory | 3. | No | |||||||
| 8 | LBTESTCDVALUE | HCT | float | 8 | Hematocrit | Central laboratory | 3. | No | |||||||
| 9 | LBTESTCDVALUE | HGB | float | 8 | Hemoglobin | 1 | Central laboratory | 5.2 | No | ||||||
| 10 | LBTESTCDVALUE | PROT | float | 8 | Protein | 1 | Central laboratory | 4.2 | No |
proc contents data=dtm.VARIABLE_METADATA;
run;The CONTENTS Procedure
| Data Set Name | DTM.VARIABLE_METADATA | Observations | 127 |
|---|---|---|---|
| Member Type | DATA | Variables | 16 |
| Engine | V9 | Indexes | 0 |
| Created | 10/13/2019 22:44:15 | Observation Length | 184 |
| Last Modified | 10/13/2019 22:44:15 | 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 | 355 |
| Obs in First Data Page | 127 |
| Number of Data Set Repairs | 0 |
| Filename | /folders/myfolders/cdisc_ucsd/sdtm/variable_metadata.sas7bdat |
| Release Created | 9.0401M6 |
| Host Created | Linux |
| Inode Number | 1928 |
| 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 | 1 | $1. | $1. | COMMENT |
| 11 | COMPUTATIONMETHODOID | Char | 14 | $14. | $14. | COMPUTATIONMETHODOID |
| 10 | DISPLAYFORMAT | Char | 3 | $3. | $3. | DISPLAYFORMAT |
| 1 | DOMAIN | Char | 6 | $6. | $6. | DOMAIN |
| 6 | LABEL | Char | 40 | $40. | $40. | LABEL |
| 5 | LENGTH | Num | 8 | 15. | LENGTH | |
| 13 | MANDATORY | Char | 3 | $3. | $3. | MANDATORY |
| 8 | ORIGIN | Char | 38 | $38. | $38. | 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=dtm.VARIABLE_METADATA;
run;| Obs | DOMAIN | VARNUM | VARIABLE | TYPE | LENGTH | LABEL | SIGNIFICANTDIGITS | ORIGIN | COMMENT | DISPLAYFORMAT | COMPUTATIONMETHODOID | CODELISTNAME | MANDATORY | ROLE | ROLECODELIST | VALUELISTOID |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AE | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 2 | AE | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 3 | AE | 3 | USUBJID | text | 25 | Unique Subject Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 4 | AE | 4 | AESEQ | integer | 8 | Sequence Number | Derived | Yes | Identifier | ROLECODE | ||||||
| 5 | AE | 5 | AETERM | text | 200 | Reported Term for the Adverse Event | CRF page 6 - AETEXT | Yes | Topic | ROLECODE | ||||||
| 6 | AE | 6 | AEDECOD | text | 200 | Dictionary-Derived Term | Derived from CDM | AEDECOD | Yes | Synonym Qualifier | ROLECODE | |||||
| 7 | AE | 7 | AEBODSYS | text | 200 | Body System or Organ Class | Derived from CDM | AEBODSYS | No | Record Qualifier | ROLECODE | |||||
| 8 | AE | 8 | AESEV | text | 40 | Severity/Intensity | CRF page 6 - AESEV | AESEV | No | Record Qualifier | ROLECODE | |||||
| 9 | AE | 9 | AESER | text | 40 | Serious Event | CRF page 6 - SERIOUS | NY | No | Record Qualifier | ROLECODE | |||||
| 10 | AE | 10 | AEACN | text | 40 | Action Taken with Study Treatment | CRF page 6 - AEACTION | ACN | No | Record Qualifier | ROLECODE | |||||
| 11 | AE | 11 | AEREL | text | 40 | Causality | CRF page 6 - AEREL | AEREL | No | Record Qualifier | ROLECODE | |||||
| 12 | AE | 12 | AESTDTC | date | 16 | Start Date/Time of Adverse Event | CRF page 6 - AESTART | No | Timing | ROLECODE | ||||||
| 13 | AE | 13 | AEENDTC | date | 16 | End Date/Time of Adverse Event | CRF page 6 - AEEND | No | Timing | ROLECODE | ||||||
| 14 | AE | 14 | AESTDY | integer | 8 | Study Day of Start of Adverse Event | Derived from AESTDTC | No | Timing | ROLECODE | ||||||
| 15 | AE | 15 | AEENDY | integer | 8 | Study Day of End of Adverse Event | Derived from AEENDTC | No | Timing | ROLECODE | ||||||
| 16 | DM | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 17 | DM | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 18 | DM | 3 | USUBJID | text | 25 | Unique Subject Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 19 | DM | 4 | SUBJID | text | 7 | Subject Identifier for the Study | CRF page 1 - UNIQUEID | Yes | Identifier | ROLECODE | ||||||
| 20 | DM | 5 | RFSTDTC | date | 16 | Subject Reference Start Date/Time | CRF page 1, first dose date | No | Record Qualifier | ROLECODE | ||||||
| 21 | DM | 6 | RFENDTC | date | 16 | Subject Reference End Date/Time | Derived, last dose date | No | Record Qualifier | ROLECODE | ||||||
| 22 | DM | 7 | SITEID | text | 7 | Study Site Identifier | CRF page 1 | Yes | Record Qualifier | ROLECODE | ||||||
| 23 | DM | 8 | BRTHDTC | date | 16 | Date/Time of Birth | CRF page 1 - DOB | No | Record Qualifier | ROLECODE | ||||||
| 24 | DM | 9 | AGE | integer | 8 | Age | Derived | 3.0 | AGECALCULATION | No | Record Qualifier | ROLECODE | ||||
| 25 | DM | 10 | AGEU | text | 5 | Age Units | Derived | AGEU | No | Variable Qualifier | ROLECODE | |||||
| 26 | DM | 11 | SEX | text | 2 | Sex | CRF page 1 - SEX | SEX | Yes | Record Qualifier | ROLECODE | |||||
| 27 | DM | 12 | RACE | text | 40 | Race | CRF page 1 - RACE | RACE | No | Record Qualifier | ROLECODE | |||||
| 28 | DM | 13 | ARMCD | text | 8 | Planned Arm Code | IVRS data | ARMCD | Yes | Record Qualifier | ROLECODE | |||||
| 29 | DM | 14 | ARM | text | 40 | Description of Planned Arm | IVRS data | ARM | Yes | Synonym Qualifier | ROLECODE | |||||
| 30 | DM | 15 | COUNTRY | text | 3 | Country | Derived | COUNTRY | Yes | Record Qualifier | ROLECODE | |||||
| 31 | EX | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 32 | EX | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 33 | EX | 3 | USUBJID | text | 25 | Unique Subject Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 34 | EX | 4 | EXSEQ | integer | 8 | Sequence Number | Derived, record count by patient | Yes | Identifier | ROLECODE | ||||||
| 35 | EX | 5 | EXTRT | text | 40 | Name of Actual Treatment | Derived - ARM | Yes | Topic | ROLECODE | ||||||
| 36 | EX | 6 | EXDOSE | integer | 8 | Dose per Administration | CRF Page 4 - DAILYDOSE | No | Record Qualifier | ROLECODE | ||||||
| 37 | EX | 7 | EXDOSU | text | 40 | Dose Units | Derived - mg | UNIT | No | Variable Qualifier | ROLECODE | |||||
| 38 | EX | 8 | EXDOSFRM | text | 40 | Dose Form | Derived - ‘TABLET, COATED’ | FRM | No | Record Qualifier | ROLECODE | |||||
| 39 | EX | 9 | EXDOSTOT | integer | 8 | Total Daily Dose | CRF Page 4 - DAILYDOSE | No | Record Qualifier | ROLECODE | ||||||
| 40 | EX | 10 | EXSTDTC | date | 16 | Start Date/Time of Treatment | CRF Page 4 - STARTYY, STARTMM, STARTDD | No | Timing | ROLECODE | ||||||
| 41 | EX | 11 | EXENDTC | date | 16 | End Date/Time of Treatment | CRF Page 4 - ENDYY, ENDMM, ENDDD | No | Timing | ROLECODE | ||||||
| 42 | EX | 12 | EXSTDY | integer | 8 | Study Day of Start of Treatment | Derived from EXSTDTC | No | Timing | ROLECODE | ||||||
| 43 | EX | 13 | EXENDY | integer | 8 | Study Day of End of Treatment | Derived from EXENDTC | No | Timing | ROLECODE | ||||||
| 44 | SUPPDM | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | ||||||||
| 45 | SUPPDM | 2 | RDOMAIN | text | 2 | Related Domain Abbreviation | Derived | Yes | ||||||||
| 46 | SUPPDM | 3 | USUBJID | text | 25 | Unique Subject Identifier | Derived | Yes | ||||||||
| 47 | SUPPDM | 4 | IDVAR | text | 8 | Identifying Variable | Derived | No | ||||||||
| 48 | SUPPDM | 5 | IDVARVAL | text | 200 | Identifying Variable Value | Derived | No | ||||||||
| 49 | SUPPDM | 6 | QNAM | text | 8 | Qualifier Variable Name | Derived | Yes | ||||||||
| 50 | SUPPDM | 7 | QLABEL | text | 40 | Qualifier Variable Label | Derived | Yes | ||||||||
| 51 | SUPPDM | 8 | QVAL | text | 200 | Data Value | CRF Page 1 | Yes | ||||||||
| 52 | SUPPDM | 9 | QORIG | text | 8 | Origin | Derived | Yes | ||||||||
| 53 | SUPPDM | 10 | QEVAL | text | 8 | Evaluator | Derived | No | ||||||||
| 54 | LB | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 55 | LB | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 56 | LB | 3 | USUBJID | text | 25 | Unique Subject Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 57 | LB | 4 | LBSEQ | integer | 8 | Sequence Number | Derived | Yes | Identifier | ROLECODE | ||||||
| 58 | LB | 5 | LBTESTCD | text | 8 | Lab Test or Examination Short Name | Derived | LBTESTCD | Yes | Topic | ROLECODE | LBTESTCDVALUE | ||||
| 59 | LB | 6 | LBTEST | text | 40 | Lab Test or Examination Name | Derived | LBTEST | Yes | Synonym Qualifier | ROLECODE | |||||
| 60 | LB | 7 | LBCAT | text | 200 | Category for Lab Test | Derived | LBCAT | No | Grouping Qualifier | ROLECODE | |||||
| 61 | LB | 8 | LBORRES | text | 200 | Result or Finding in Original Units | Central laboratory | No | Result Qualifier | ROLECODE | ||||||
| 62 | LB | 9 | LBORRESU | text | 200 | Original Units | Central laboratory | UNIT | No | Variable Qualifier | ROLECODE | |||||
| 63 | LB | 10 | LBORNRLO | text | 200 | Reference Range Lower Limit in Orig Unit | Central laboratory | No | Variable Qualifier | ROLECODE | ||||||
| 64 | LB | 11 | LBORNRHI | text | 200 | Reference Range Upper Limit in Orig Unit | Central laboratory | No | Variable Qualifier | ROLECODE | ||||||
| 65 | LB | 12 | LBSTRESC | text | 200 | Character Result/Finding in Std Format | Derived | No | Result Qualifier | ROLECODE | ||||||
| 66 | LB | 13 | LBSTRESN | float | 8 | Numeric Result/Finding in Standard Units | Derived | No | Result Qualifier | ROLECODE | ||||||
| 67 | LB | 14 | LBSTRESU | text | 200 | Standard Units | Derived | UNIT | No | Variable Qualifier | ROLECODE | |||||
| 68 | LB | 15 | LBSTNRLO | float | 8 | Reference Range Lower Limit-Std Units | Derived | No | Variable Qualifier | ROLECODE | ||||||
| 69 | LB | 16 | LBSTNRHI | float | 8 | Reference Range Upper Limit-Std Units | Derived | No | Variable Qualifier | ROLECODE | ||||||
| 70 | LB | 17 | LBNRIND | text | 40 | Reference Range Indicator | Derived | LBNRIND | No | Variable Qualifier | ROLECODE | |||||
| 71 | LB | 18 | LBBLFL | text | 2 | Baseline Flag | Derived | NY | No | Record Qualifier | ROLECODE | |||||
| 72 | LB | 19 | VISITNUM | integer | 8 | Visit Number | Derived | No | Timing | ROLECODE | ||||||
| 73 | LB | 20 | VISIT | text | 200 | Visit Name | Central laboratory | VISIT | No | Timing | ROLECODE | |||||
| 74 | LB | 21 | LBDTC | date | 16 | Date/Time of Specimen Collection | Central laboratory | No | Timing | ROLECODE | ||||||
| 75 | LB | 22 | LBDY | integer | 8 | Study Day of Specimen Collection | Derived | No | Timing | ROLECODE | ||||||
| 76 | TA | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 77 | TA | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 78 | TA | 3 | ARMCD | text | 8 | Planned Arm Code | Derived | ARMCD | Yes | Topic | ROLECODE | |||||
| 79 | TA | 4 | ARM | text | 40 | Description of Planned Arm | Derived | ARM | Yes | Synonym Qualifier | ROLECODE | |||||
| 80 | TA | 5 | TAETORD | integer | 8 | Order of Element within Arm | Derived | Yes | Identifier | ROLECODE | ||||||
| 81 | TA | 6 | ETCD | text | 8 | Element Code | Derived | Yes | Record Qualifier | ROLECODE | ||||||
| 82 | TA | 7 | ELEMENT | text | 40 | Description of Element | Derived | No | Synonym Qualifier | ROLECODE | ||||||
| 83 | TA | 8 | TABRANCH | text | 200 | Branch | Derived | No | Rule | ROLECODE | ||||||
| 84 | TA | 9 | TATRANS | text | 200 | Transition Rule | Derived | No | Rule | ROLECODE | ||||||
| 85 | TA | 10 | EPOCH | text | 200 | Epoch | Derived | No | Timing | ROLECODE | ||||||
| 86 | TE | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 87 | TE | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 88 | TE | 3 | ETCD | text | 8 | Element Code | Derived | Yes | Topic | ROLECODE | ||||||
| 89 | TE | 4 | ELEMENT | text | 40 | Description of Element | Derived | Yes | Synonym Qualifier | ROLECODE | ||||||
| 90 | TE | 5 | TESTRL | text | 200 | Rule for Start of Element | Derived | Yes | Rule | ROLECODE | ||||||
| 91 | TE | 6 | TEENRL | text | 200 | Rule for End of Element | Derived | No | Rule | ROLECODE | ||||||
| 92 | TE | 7 | TEDUR | text | 40 | Planned Duration of Element | Derived | No | Timing | ROLECODE | ||||||
| 93 | TI | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 94 | TI | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 95 | TI | 3 | IETESTCD | text | 8 | Incl/Excl Criterion Short Name | Derived | Yes | Topic | ROLECODE | ||||||
| 96 | TI | 4 | IETEST | text | 200 | Inclusion/Exclusion Criterion | Derived | Yes | Synonym Qualifier | ROLECODE | ||||||
| 97 | TI | 5 | IECAT | text | 200 | Inclusion/Exclusion Category | Derived | IECAT | Yes | Grouping Qualifier | ROLECODE | |||||
| 98 | TI | 6 | IESCAT | text | 200 | Inclusion/Exclusion Subcategory | Derived | No | Grouping Qualifier | ROLECODE | ||||||
| 99 | TI | 7 | TIRL | text | 200 | Inclusion/Exclusion Criterion Rule | Derived | No | Rule | ROLECODE | ||||||
| 100 | TI | 8 | TIVERS | text | 200 | Protocol Criteria Versions | Derived | No | Record Qualifier | ROLECODE | ||||||
| 101 | TS | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 102 | TS | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 103 | TS | 3 | TSSEQ | integer | 8 | Sequence Number | Derived | Yes | Identifier | ROLECODE | ||||||
| 104 | TS | 4 | TSGRPID | text | 40 | Group ID | Derived | No | Identifier | ROLECODE | ||||||
| 105 | TS | 5 | TSPARMCD | text | 8 | Trial Summary Parameter Short Name | Derived | TSPARMCD | Yes | Topic | ROLECODE | |||||
| 106 | TS | 6 | TSPARM | text | 200 | Trial Summary Parameter | Derived | TSPARM | Yes | Synonym Qualifier | ROLECODE | |||||
| 107 | TS | 7 | TSVAL | text | 200 | Parameter Value | Derived | Yes | Result Qualifier | ROLECODE | ||||||
| 108 | TV | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 109 | TV | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 110 | TV | 3 | VISITNUM | integer | 8 | Visit Number | Derived | Yes | Topic | ROLECODE | ||||||
| 111 | TV | 4 | VISIT | text | 200 | Visit Name | Derived | No | Synonym Qualifier | ROLECODE | ||||||
| 112 | TV | 5 | ARMCD | text | 8 | Planned Arm Code | Derived | ARMCD | No | Record Qualifier | ROLECODE | |||||
| 113 | TV | 6 | ARM | text | 40 | Description of Planned Arm | Derived | ARM | No | Synonym Qualifier | ROLECODE | |||||
| 114 | TV | 7 | TVSTRL | text | 200 | Visit Start Rule | Derived | Yes | Rule | ROLECODE | ||||||
| 115 | TV | 8 | TVENRL | text | 200 | Visit End Rule | Derived | No | Rule | ROLECODE | ||||||
| 116 | XP | 1 | STUDYID | text | 15 | Study Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 117 | XP | 2 | DOMAIN | text | 2 | Domain Abbreviation | Derived | Yes | Identifier | ROLECODE | ||||||
| 118 | XP | 3 | USUBJID | text | 25 | Unique Subject Identifier | Derived | Yes | Identifier | ROLECODE | ||||||
| 119 | XP | 4 | XPSEQ | integer | 8 | Sequence Number | Derived | Yes | Identifier | ROLECODE | ||||||
| 120 | XP | 5 | XPTESTCD | text | 8 | Pain Test Short Name | Derived | XPTESTCD | Yes | Topic | ROLECODE | |||||
| 121 | XP | 6 | XPTEST | text | 40 | Pain Test Name | Derived | XPTEST | Yes | Synonym Qualifier | ROLECODE | |||||
| 122 | XP | 7 | XPORRES | text | 200 | Result or Finding in Original Units | CRF Page 5 | No | Result Qualifier | ROLECODE | ||||||
| 123 | XP | 8 | VISITNUM | integer | 8 | Visit Number | Derived | No | Timing | ROLECODE | ||||||
| 124 | XP | 9 | VISIT | text | 200 | Visit Name | CRF Page 5 | VISIT | No | Timing | ROLECODE | |||||
| 125 | XP | 10 | XPDTC | date | 16 | Date/Time of Collection | CRF Page 5 | No | Timing | ROLECODE | ||||||
| 126 | XP | 11 | XPDY | integer | 8 | Study Day of Collection | Derived | No | Timing | ROLECODE | ||||||
| 127 | XP | 12 | XPSTRESN | integer | 8 | Result or Finding in Original Units | CRF Page 5 | 3.0 | No | Record Qualifier | ROLECODE |