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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EPOCH | EXSTDTC | EXENDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_EX_010 | XYZ | EX | XYZ-767-001 | 1 | Drug 1 | 500 | mg | TREATMENT 1 | 2016-02-14 | 2016-03-13 | |
| IG33_DS_EX_010 | XYZ | EX | XYZ-767-001 | 2 | Drug 1 | 500 | mg | TREATMENT 2 | 2016-03-14 | 2016-04-19 | |
| IG33_DS_EX_010 | XYZ | EX | XYZ-767-001 | 3 | Investigational Drug | 1000 | mg | TREATMENT 2 | 2016-03-14 | 2016-04-19 | |
| IG33_DS_EX_010 | XYZ | EX | XYZ-767-002 | 1 | Drug 2 | 500 | mg | TREATMENT 1 | 2016-02-21 | 2016-03-23 | |
| IG33_DS_EX_010 | XYZ | EX | XYZ-767-002 | 2 | Drug 2 | 500 | mg | TREATMENT 2 | 2016-03-24 | 2016-04-24 | |
| IG33_DS_EX_010 | XYZ | EX | XYZ-767-002 | 3 | Investigational Drug | 1000 | mg | TREATMENT 2 | 2016-03-24 | 2016-04-24 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXLNKID | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_001 | ABC | EX | ABC1001 | 1 | A2-20110114 | DRUG X | 1000 | mg | TABLET, EXTENDED RELEASE | QD | ORAL | TREATMENT | 2011-01-14 | 2011-01-28 | 1 | 15 | |
| IG33_EC_EX_001 | ABC | EX | ABC2001 | 1 | A2-20110114 | DRUG Z | 500 | mg | TABLET | QD | ORAL | TREATMENT | 2011-01-14 | 2011-01-23 | 1 | 10 | |
| IG33_EC_EX_001 | ABC | EX | ABC2001 | 2 | A2-20110125 | DRUG Z | 500 | mg | TABLET | QD | ORAL | TREATMENT | 2011-01-25 | 2011-01-28 | 12 | 15 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXSPID | EXLNKID | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOC | VISITNUM | VISIT | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_002 | ABC | EX | ABC3001 | 1 | V3 | DRUG X | 3 | mg/kg | INJECTION | ONCE | SUBCUTANEOUS | ABDOMEN | 3 | VISIT 3 | TREATMENT | 2009-05-10 | 2009-05-10 | 21 | 21 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_003 | ABC | EX | ABC4001 | 1 | DRUG X | 20 | mg | TABLET | QD | ORAL | TREATMENT | 2011-01-14 | 2011-01-20 | 1 | 7 | |
| IG33_EC_EX_003 | ABC | EX | ABC4001 | 2 | DRUG X | 10 | mg | TABLET | QD | ORAL | TREATMENT | 2011-01-21 | 2011-01-21 | 8 | 8 | |
| IG33_EC_EX_003 | ABC | EX | ABC4001 | 3 | DRUG X | 30 | mg | TABLET | QD | ORAL | TREATMENT | 2011-01-22 | 2011-01-22 | 9 | 9 | |
| IG33_EC_EX_003 | ABC | EX | ABC4001 | 4 | DRUG X | 20 | mg | TABLET | QD | ORAL | TREATMENT | 2011-01-23 | 2011-01-28 | 10 | 15 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXLNKID | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY | EXTPT | EXTPTNUM |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_005 | ABC | EX | ABC5001 | 1 | 20120101-20120108-AM | DRUG X | 10 | mg | TABLET | QD | ORAL | TREATMENT | 2012-01-01 | 2012-01-08 | 1 | 8 | AM | 1 | |
| IG33_EC_EX_005 | ABC | EX | ABC5001 | 2 | 20120101-20120108-PM | DRUG X | 10 | mg | TABLET | QD | ORAL | TREATMENT | 2012-01-01 | 2012-01-08 | 1 | 8 | PM | 2 | |
| IG33_EC_EX_005 | ABC | EX | ABC5002 | 1 | 20120201-20120208-AM | DRUG X | 10 | mg | TABLET | QD | ORAL | TREATMENT | 2012-02-01 | 2012-02-08 | 1 | 8 | AM | 1 | |
| IG33_EC_EX_005 | ABC | EX | ABC5002 | 2 | 20120201-20120208-PM | PLACEBO | 0 | mg | TABLET | QD | ORAL | TREATMENT | 2012-02-01 | 2012-02-08 | 1 | 8 | PM | 2 | |
| IG33_EC_EX_005 | ABC | EX | ABC5003 | 1 | 20120301-20120308-AM | PLACEBO | 0 | mg | TABLET | QD | ORAL | TREATMENT | 2012-03-01 | 2012-03-08 | 1 | 8 | AM | 1 | |
| IG33_EC_EX_005 | ABC | EX | ABC5003 | 2 | 20120301-20120308-PM | PLACEBO | 0 | mg | TABLET | QD | ORAL | TREATMENT | 2012-03-01 | 2012-03-08 | 1 | 8 | PM | 2 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY | EXTPT | EXELTM | EXTPTREF |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 1 | DRUG A | 20 | mg | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-01T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 2 | PLACEBO | 0 | mg | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-01T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 3 | DRUG A | 20 | mg | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-02T07:30 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 4 | PLACEBO | 0 | mg | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-02T07:30 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 5 | DRUG A | 20 | mg | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-03T07:32 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 6 | PLACEBO | 0 | mg | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-03T07:32 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 7 | PLACEBO | 0 | mg | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-09T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 8 | DRUG B | 30 | mg | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-09T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 9 | PLACEBO | 0 | mg | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-10T07:30 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 10 | DRUG B | 30 | mg | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-10T07:30 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 11 | PLACEBO | 0 | mg | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-11T07:34 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789001 | 12 | DRUG B | 30 | mg | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-11T07:34 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 1 | PLACEBO | 0 | mg | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-03T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 2 | DRUG B | 30 | mg | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-03T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 3 | PLACEBO | 0 | mg | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-04T07:24 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 4 | DRUG B | 30 | mg | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-04T07:24 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 5 | PLACEBO | 0 | mg | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-05T07:24 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 6 | DRUG B | 30 | mg | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-05T07:24 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 7 | DRUG A | 20 | mg | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-11T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 8 | PLACEBO | 0 | mg | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-11T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 9 | DRUG A | 20 | mg | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-12T07:43 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 10 | PLACEBO | 0 | mg | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-12T07:43 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 11 | DRUG A | 20 | mg | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-13T07:38 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | ||
| IG33_EC_EX_006 | 56789 | EX | 56789003 | 12 | PLACEBO | 0 | mg | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-13T07:38 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXLNKID | EXLNKGRP | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXADJ | VISITNUM | VISIT | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_007 | ABC123 | EX | ABC123-0201 | 1 | 20090213T1000 | V1 | DRUG Z | 9.9 | mg/kg | SOLUTION | CONTINUOUS | INTRAVENOUS | 1 | VISIT 1 | TREATMENT | 2009-02-13T10:00 | 2009-02-13T10:00 | 1 | 1 | ||
| IG33_EC_EX_007 | ABC123 | EX | ABC123-0201 | 2 | 20090220T1100 | V2 | DRUG Z | 2.6 | mg/kg | SOLUTION | CONTINUOUS | INTRAVENOUS | Injection site reaction | 2 | VISIT 2 | TREATMENT | 2009-02-20T11:00 | 2009-02-20T11:00 | 8 | 8 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EPOCH | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EX_008 | ABC | EX | ABC7001 | 1 | DRUG X | 100 | mg | TABLET | QD | ORAL | TREATMENT | 2012-01-13 | 2012-01-14 | 1 | 2 | |
| IG33_EC_EX_008 | ABC | EX | ABC7001 | 2 | DRUG X | 200 | mg | TABLET | QD | ORAL | TREATMENT | 2012-01-16 | 2012-01-16 | 4 | 4 | |
| IG33_EC_EX_008 | ABC | EX | ABC7001 | 3 | DRUG X | 100 | mg | TABLET | QD | ORAL | TREATMENT | 2012-01-17 | 2012-01-20 | 5 | 8 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXADJ | EPOCH | EXSTDTC | EXENDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EX_EX_001 | 37841 | EX | 37841001 | 1 | DRUG A | 20 | mg | TABLET | QD | ORAL | TREATMENT | 2002-07-01 | 2002-10-01 | ||
| IG33_EX_EX_001 | 37841 | EX | 37841002 | 1 | DRUG A | 20 | mg | TABLET | QD | ORAL | TREATMENT | 2002-04-02 | 2002-04-21 | ||
| IG33_EX_EX_001 | 37841 | EX | 37841002 | 2 | DRUG A | 15 | mg | TABLET | QD | ORAL | Reduced due to toxicity | TREATMENT | 2002-04-22 | 2002-07-01 | |
| IG33_EX_EX_001 | 37841 | EX | 37841003 | 1 | DRUG A | 20 | mg | TABLET | QD | ORAL | TREATMENT | 2002-05-09 | 2002-06-01 | ||
| IG33_EX_EX_001 | 37841 | EX | 37841003 | 2 | DRUG A | 25 | mg | TABLET | QD | ORAL | Increased due to suboptimal efficacy | TREATMENT | 2002-06-02 | 2002-07-01 | |
| IG33_EX_EX_001 | 37841 | EX | 37841003 | 3 | DRUG A | 30 | mg | TABLET | QD | ORAL | Increased due to suboptimal efficacy | TREATMENT | 2002-07-02 | 2002-08-01 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | EXSPID | EXTRT | EXDOSE | EXDOSEU | EXROUTE | EXLOC |
|---|---|---|---|---|---|---|---|---|---|---|
| IG33_SR_EX_002 | CC-001 | EX | 101 | 1 | Dog Epi IgG | 0 | mg | CUTANEOUS | FOREARM | |
| IG33_SR_EX_002 | CC-001 | EX | 101 | 2 | Dog Epi IgG | 0.1 | mg | CUTANEOUS | FOREARM | |
| IG33_SR_EX_002 | CC-001 | EX | 101 | 3 | Dog Epi IgG | 0.5 | mg | CUTANEOUS | FOREARM | |
| IG33_SR_EX_002 | CC-001 | EX | 101 | 4 | Dog Epi IgG | 1 | mg | CUTANEOUS | FOREARM | |
| IG33_SR_EX_002 | CC-001 | EX | 101 | 5 | Dog Epi IgG | 1.5 | mg | CUTANEOUS | FOREARM | |
| IG33_SR_EX_002 | CC-001 | EX | 101 | 6 | Dog Epi IgG | 2 | mg | CUTANEOUS | FOREARM |