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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | SITEID | INVNAM | BRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DM_DM_001 | ABC123 | DM | ABC12301001 | 01001 | 2006-01-12 | 2006-03-10 | 2006-01-12 | 2006-03-10 | 2006-01-03 | 2006-04-01 | 01 | JOHNSON, M | 1948-12-13 | 57 | YEARS | M | WHITE | HISPANIC OR LATINO | A | Drug A | A | Drug A | USA | |||
| IG33_DM_DM_001 | ABC123 | DM | ABC12301002 | 01002 | 2006-01-15 | 2006-02-28 | 2006-01-15 | 2006-02-28 | 2006-01-04 | 2006-03-26 | 01 | JOHNSON, M | 1955-03-22 | 50 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | P | Placebo | P | Placebo | USA | |||
| IG33_DM_DM_001 | ABC123 | DM | ABC12301003 | 01003 | 2006-01-16 | 2006-03-19 | 2006-01-16 | 2006-03-19 | 2006-01-02 | 2006-03-19 | 01 | JOHNSON, M | 1938-01-19 | 68 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | P | Placebo | P | Placebo | USA | |||
| IG33_DM_DM_001 | ABC123 | DM | ABC12301004 | 01004 | 2006-01-07 | 2006-01-08 | 01 | JOHNSON, M | 1941-07-02 | M | ASIAN | NOT HISPANIC OR LATINO | SCREEN FAILURE | USA | ||||||||||||
| IG33_DM_DM_001 | ABC123 | DM | ABC12302001 | 02001 | 2006-02-02 | 2006-03-31 | 2006-02-02 | 2006-03-31 | 2006-01-15 | 2006-04-12 | 02 | GONZALEZ, E | 1950-06-23 | 55 | YEARS | F | AMERICAN INDIAN OR ALASKA NATIVE | NOT HISPANIC OR LATINO | P | Placebo | P | Placebo | USA | |||
| IG33_DM_DM_001 | ABC123 | DM | ABC12302002 | 02002 | 2006-02-03 | 2006-04-05 | 2006-02-03 | 2006-04-05 | 2006-01-10 | 2006-04-25 | 02 | GONZALEZ, E | 1956-05-05 | 49 | YEARS | F | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS | NOT HISPANIC OR LATINO | A | Drug A | A | Drug A | USA |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | RACE | ETHNIC |
|---|---|---|---|---|---|---|
| IG33_DM_DM_002 | ABC | DM | 001 | ASIAN | NOT HISPANIC OR LATINO | |
| IG33_DM_DM_002 | ABC | DM | 002 | WHITE | HISPANIC OR LATINO |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | RACE |
|---|---|---|---|---|---|
| IG33_DM_DM_003 | ABC | DM | 001 | OTHER | |
| IG33_DM_DM_003 | ABC | DM | 002 | MULTIPLE | |
| IG33_DM_DM_003 | ABC | DM | 003 | ||
| IG33_DM_DM_003 | ABC | DM | 004 | ASIAN |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | RACE |
|---|---|---|---|---|---|
| IG33_DM_DM_004 | ABC | DM | 001 | ASIAN | |
| IG33_DM_DM_004 | ABC | DM | 002 | ASIAN |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | RACE |
|---|---|---|---|---|---|
| IG33_DM_DM_005 | ABC | DM | 001 | ASIAN | |
| IG33_DM_DM_005 | ABC | DM | 002 | WHITE |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DM_DM_006 | ABC | DM | 001 | A | Drug A | A | Drug A | |||
| IG33_DM_DM_006 | ABC | DM | 002 | B | Drug B | B | Drug B | |||
| IG33_DM_DM_006 | ABC | DM | 003 | SCREEN FAILURE | ||||||
| IG33_DM_DM_006 | ABC | DM | 004 | NOT ASSIGNED | ||||||
| IG33_DM_DM_006 | ABC | DM | 005 | A | Drug A | ASSIGNED, NOT TREATED |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DM_DM_007 | DEF | DM | 001 | AA | A-OPEN A | AA | A-OPEN A | |||
| IG33_DM_DM_007 | DEF | DM | 002 | A | A | A | A | |||
| IG33_DM_DM_007 | DEF | DM | 003 | AR | A-RESCUE | BR | B-RESCUE |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DM_SUPPDM_001 | ABC | DM | 001 | RACEOTH | Race, Other | BRAZILIAN | CRF | ||||
| IG33_DM_SUPPDM_001 | ABC | DM | 002 | RACE1 | Race 1 | BLACK OR AFRICAN AMERICAN | CRF | ||||
| IG33_DM_SUPPDM_001 | ABC | DM | 002 | RACE2 | Race 2 | AMERICAN INDIAN OR ALASKA NATIVE | CRF | ||||
| IG33_DM_SUPPDM_001 | ABC | DM | 002 | RACE3 | Race 3 | OTHER | CRF | ||||
| IG33_DM_SUPPDM_001 | ABC | DM | 002 | RACEOTH | Race, Other | ABORIGINE | CRF |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DM_SUPPDM_002 | ABC | DM | 001 | RACEOR | Original Race | NON-JAPANESE | CRF | ||||
| IG33_DM_SUPPDM_002 | ABC | DM | 002 | RACEOR | Original Race | JAPANESE | CRF |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DM_SUPPDM_003 | ABC | DM | 001 | RACEOR | Original Race | JAPANESE | CRF | ||||
| IG33_DM_SUPPDM_003 | ABC | DM | 002 | RACEOR | Original Race | SWEDISH | CRF |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | SUBJID | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | SITEID | INVNAM | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DM_010 | XYZ | DM | XYZ-767-001 | 001 | 2016-02-14 | 2016-04-19 | 2016-02-02 | 2016-04-24 | 01 | ADAMS, M | DG1INDG | Drug-1+Investigation-Drug | DG1INDG | Drug-1+Investigation-Drug | |||
| IG33_DS_DM_010 | XYZ | DM | XYZ-767-002 | 002 | 2016-02-21 | 2016-04-24 | 2016-02-04 | 2016-04-29 | 01 | ADAMS, M | DG2INDG | Drug-2+Investigation-Drug | DG2INDG | Drug-2+Investigation-Drug |
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| EXAMPLE_NUM | ROW_DESCRIPTION | USUBJID | SUBJID | RFSTDTC | RFENDTC | SITEID | INVNAM | BIRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_SE_DM_001 | 789 | 001 | 2006-06-03 | 2006-06-17 | 01 | SMITH, J | 1948-12-13 | 57 | YEARS | M | WHITE | HISPANIC OR LATINO | IO | IV-ORAL | IO | IV-ORAL | USA | |||
| IG33_SE_DM_001 | 790 | 002 | 2006-06-03 | 2006-06-17 | 01 | SMITH, J | 1955-03-22 | 51 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | OI | ORAL-IV | IO | IV-ORAL | USA | |||
| IG33_SE_DM_001 | 791 | 003 | 2006-06-03 | 2006-06-07 | 01 | SMITH, J | 1956-07-17 | 49 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | IO | IV-ORAL | IO | IV-ORAL | USA |
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| EXAMPLE_NUM | ROW_DESCRIPTION | USUBJID | SUBJID | RFSTDTC | RFENDTC | SITEID | INVNAM | BIRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_SE_DM_002 | 123 | 012 | 2006-06-03 | 2006-06-10 | 01 | JONES, D | 1943-12-08 | 62 | YEARS | M | ASIAN | HISPANIC OR LATINO | A | A | A | A | USA | |||
| IG33_SE_DM_002 | 456 | 103 | 2006-05-03 | 2006-07-30 | 01 | JONES, D | 1950-05-15 | 55 | YEARS | F | WHITE | NOT HISPANIC OR LATINO | AR | A-Rescue | UNPLANNED TREATMENT | Drug B dispensed for part of Drug A element | USA |