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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSDTC | DSSTDTC |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DD_DS_002 | ABC123 | DS | ABC12301001 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | 2011-01-02 | 2011-01-02 | |
| IG33_DD_DS_002 | ABC123 | DS | ABC12301001 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | 2011-01-03 | 2011-01-03 | |
| IG33_DD_DS_002 | ABC123 | DS | ABC12301001 | 3 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | 2011-01-03 | 2011-01-03 | |
| IG33_DD_DS_002 | ABC123 | DS | ABC12301001 | 4 | SUDDEN CARDIAC DEATH | DEATH | DISPOSITION EVENT | 2011-01-10 | 2011-01-10 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | EPOCH | DSDTC | DSSTDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_001 | ABC123 | DS | 123101 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING | 2003-09-21 | 2003-09-21 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123101 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING | 2003-09-30 | 2003-09-30 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123101 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-29 | |
| IG33_DS_DS_001 | ABC123 | DS | 123101 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-31 | 2003-10-31 | |
| IG33_DS_DS_001 | ABC123 | DS | 123101 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-11-15 | 2003-11-15 | |
| IG33_DS_DS_001 | ABC123 | DS | 123102 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING | 2003-11-21 | 2003-11-21 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123102 | 2 | SUBJECT DENIED MRI PROCEDURE | PROTOCOL VIOLATION | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-11-22 | 2003-11-20 | |
| IG33_DS_DS_001 | ABC123 | DS | 123103 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING | 2003-09-15 | 2003-09-15 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123103 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING | 2003-09-30 | 2003-09-30 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123103 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-22 | |
| IG33_DS_DS_001 | ABC123 | DS | 123103 | 4 | SUBJECT MOVED | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-31 | 2003-10-31 | |
| IG33_DS_DS_001 | ABC123 | DS | 123104 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING | 2003-09-15 | 2003-09-15 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123104 | 3 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING | 2003-09-30 | 2003-09-30 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123104 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-09-30 | 2003-09-22 | |
| IG33_DS_DS_001 | ABC123 | DS | 123104 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-15 | 2003-10-15 | |
| IG33_DS_DS_001 | ABC123 | DS | 123104 | 5 | AUTOMOBILE ACCIDENT | DEATH | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-10-31 | 2003-10-29 | |
| IG33_DS_DS_001 | ABC123 | DS | 123105 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING | 2003-09-28 | 2003-09-28 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123105 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING | 2003-10-02 | 2003-10-02 | ||
| IG33_DS_DS_001 | ABC123 | DS | 123105 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-10-02 | 2003-10-02 | |
| IG33_DS_DS_001 | ABC123 | DS | 123105 | 4 | ANEMIA | ADVERSE EVENT | DISPOSITION EVENT | STUDY PARTICIPATION | TREATMENT | 2003-10-17 | 2003-10-17 | |
| IG33_DS_DS_001 | ABC123 | DS | 123105 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2003-11-02 | 2003-11-02 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | EPOCH | DSSTDTC |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_002 | ABC456 | DS | 456101 | 1 | COMPLETED | COMPLETED | DISPOSITION EVENT | FOLLOW-UP | 2003-09-21 | |
| IG33_DS_DS_002 | ABC456 | DS | 456102 | 1 | SUBJECT TAKING STUDY MED ERRATICALLY | PROTOCOL VIOLATION | DISPOSITION EVENT | TREATMENT | 2003-09-29 | |
| IG33_DS_DS_002 | ABC456 | DS | 456103 | 1 | LOST TO FOLLOW-UP | LOST TO FOLLOW-UP | DISPOSITION EVENT | TREATMENT | 2003-10-15 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | EPOCH | DSSTDTC |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_003 | ABC789 | DS | 789101 | 1 | COMPLETED | COMPLETED | DISPOSITION EVENT | TREATMENT | 2004-09-12 | |
| IG33_DS_DS_003 | ABC789 | DS | 789101 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | FOLLOW-UP | 2004-12-20 | |
| IG33_DS_DS_003 | ABC789 | DS | 789102 | 1 | SKIN RASH | ADVERSE EVENT | DISPOSITION EVENT | TREATMENT | 2004-09-30 | |
| IG33_DS_DS_003 | ABC789 | DS | 789102 | 2 | SUBJECT HAD SEVERE RASH | TREATMENT UNBLINDED | OTHER EVENT | TREATMENT | 2004-10-01 | |
| IG33_DS_DS_003 | ABC789 | DS | 789102 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | FOLLOW-UP | 2004-12-28 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | EPOCH | DSDTC | DSSTDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_004 | ABC123 | DS | 123102 | 1 | Heart Failure | DEATH | DISPOSITION EVENT | TREATMENT | 2003-09-29 | 2003-09-29 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | DSSTDTC | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_005 | XXX | DS | XXX-767-001 | 1 | PERSISTENT HIGH-LEVEL POSITIVE CULTURES, PER PROTOCOL, LEVOFLOXACIN REMOVAL RECOMMENDED | PHYSICIAN DECISION | DISPOSITION EVENT | LEVOFLOXACIN | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_005 | XXX | DS | XXX-767-001 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | ISONIAZID | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_005 | XXX | DS | XXX-767-001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-02-25 | TREATMENT 1 | |
| IG33_DS_DS_005 | XXX | DS | XXX-767-001 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | ISONIAZID | 2016-03-14 | TREATMENT 2 | |
| IG33_DS_DS_005 | XXX | DS | XXX-767-001 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-03-24 | TREATMENT 2 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | DSSTDTC | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_006 | XXX | DS | XXX-767-001 | 1 | PERSISTENT HIGH-LEVEL POSITIVE CULTURES, PER PROTOCOL, LEVOFLOXACIN REMOVAL RECOMMENDED | PHYSICIAN DECISION | DISPOSITION EVENT | LEVOFLOXACIN | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_006 | XXX | DS | XXX-767-001 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | ISONIAZID | 2016-03-14 | TREATMENT 2 | |
| IG33_DS_DS_006 | XXX | DS | XXX-767-001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-03-24 | TREATMENT 2 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | DSSTDTC | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_007 | XXX | DS | XXX-767-001 | 1 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY TREATMENT | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_007 | XXX | DS | XXX-767-001 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_007 | XXX | DS | XXX-767-001 | 3 | SKIN RASH | ADVERSE EVENT | DISPOSITION EVENT | STUDY TREATMENT | 2016-03-14 | TREATMENT 2 | |
| IG33_DS_DS_007 | XXX | DS | XXX-767-001 | 4 | SKIN RASH | ADVERSE EVENT | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-03-14 | TREATMENT 2 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | DSSTDTC | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_008 | XXX | DS | XXX-767-001 | 1 | COMPLETED | COMPLETED | DISPOSITION EVENT | BLINDED DRUG A | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_008 | XXX | DS | XXX-767-001 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | BLINDED DRUG B | 2016-02-15 | TREATMENT 1 | |
| IG33_DS_DS_008 | XXX | DS | XXX-767-001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-02-25 | TREATMENT 1 | |
| IG33_DS_DS_008 | XXX | DS | XXX-767-001 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | BLINDED DRUG A | 2016-03-14 | TREATMENT 2 | |
| IG33_DS_DS_008 | XXX | DS | XXX-767-001 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | BLINDED DRUG B | 2016-03-14 | TREATMENT 2 | |
| IG33_DS_DS_008 | XXX | DS | XXX-767-001 | 6 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-03-24 | TREATMENT 2 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | EPOCH | DSSTDTC |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_009 | XXX | DS | XXX-767-001 | 1 | INFORMED CONSENT FOR STUDY ENROLLMENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING | 2016-02-22 | |
| IG33_DS_DS_009 | XXX | DS | XXX-767-001 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING | 2016-02-26 | |
| IG33_DS_DS_009 | XXX | DS | XXX-767-001 | 3 | INFORMED CONSENT FOR AMENDMENT ONE OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | TREATMENT 1 | 2016-04-12 | |
| IG33_DS_DS_009 | XXX | DS | XXX-767-001 | 4 | INFORMED CONSENT FOR PHARMACOGENETIC RESEARCH OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | TREATMENT 2 | 2016-06-08 | |
| IG33_DS_DS_009 | XXX | DS | XXX-767-001 | 5 | INFORMED CONSENT FOR PK SUB-STUDY OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | TREATMENT 2 | 2016-06-23 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | DSSTDTC | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 1 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | 2016-02-13 | SCREENING | ||
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-02-13 | SCREENING | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | DRUG1 | 2016-03-13 | TREATMENT 1 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-03-14 | TREATMENT 1 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | DG1INDG | 2016-04-19 | TREATMENT 2 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 6 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-04-20 | TREATMENT 2 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-001 | 7 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-04-24 | FOLLOW-UP | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 1 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | 2016-02-20 | SCREENING | ||
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 2 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-02-20 | SCREENING | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | DRUG2 | 2016-03-23 | TREATMENT 1 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-03-24 | TREATMENT 1 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | DG2INDG | 2016-04-24 | TREATMENT 2 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 6 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-04-25 | TREATMENT 2 | |
| IG33_DS_DS_010 | XYZ | DS | XYZ-767-002 | 7 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2016-04-29 | FOLLOW-UP |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | DSSTDTC | TAETORD | EPOCH |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_DS_011 | DS10 | DS | 101 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | 2015-01-21 | 1 | SCREENING | ||
| IG33_DS_DS_011 | DS10 | DS | 101 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | 2015-02-01 | 1 | SCREENING | ||
| IG33_DS_DS_011 | DS10 | DS | 101 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | 2015-02-01 | 1 | SCREENING | |
| IG33_DS_DS_011 | DS10 | DS | 101 | 4 | Toxicity | ADVERSE EVENT | DISPOSITION EVENT | DRUG C | 2015-03-06 | 2 | TREATMENT | |
| IG33_DS_DS_011 | DS10 | DS | 101 | 5 | Disease progression | PROGRESSIVE DISEASE | DISPOSITION EVENT | DRUGS A & B | 2015-04-14 | 6 | TREATMENT | |
| IG33_DS_DS_011 | DS10 | DS | 101 | 6 | Disease progression | PROGRESSIVE DISEASE | DISPOSITION EVENT | STUDY PARTICIPATION | 2015-04-26 | 6 | TREATMENT | |
| IG33_DS_DS_011 | DS10 | DS | 101 | 7 | Death due to cancer | DEATH | DISPOSITION EVENT | STUDY PARTICIPATION | 2015-09-19 | 8 | FOLLOW-UP |