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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECLNKID | ECTRT | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECDOSFRQ | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_001 | ABC | EC | ABC1001 | 1 | A2-20110114 | BOTTLE A | Y | Y | 2 | TABLET | QD | TREATMENT | 2011-01-14 | 2011-01-28 | 1 | 15 | |
| IG33_EC_EC_001 | ABC | EC | ABC2001 | 1 | A2-20110114 | BOTTLE A | Y | Y | 2 | TABLET | QD | TREATMENT | 2011-01-14 | 2011-01-23 | 1 | 10 | |
| IG33_EC_EC_001 | ABC | EC | ABC2001 | 2 | A0-20110124 | BOTTLE A | Y | N | TABLET | QD | TREATMENT | 2011-01-24 | 2011-01-24 | 11 | 11 | ||
| IG33_EC_EC_001 | ABC | EC | ABC2001 | 3 | A2-20110125 | BOTTLE A | Y | Y | 2 | TABLET | QD | TREATMENT | 2011-01-25 | 2011-01-28 | 12 | 15 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECSPID | ECLNKID | ECTRT | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECDOSFRM | ECDOSFRQ | ECROUTE | ECLOC | ECLAT | VISITNUM | VISIT | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_002 | ABC | EC | ABC3001 | 1 | INJ1 | V3 | DRUG X | Y | Y | 5 | mL | INJECTION | ONCE | SUBCUTANEOUS | ABDOMEN | LEFT | 3 | VISIT 3 | TREATMENT | 2009-05-10 | 2009-05-10 | 21 | 21 | |
| IG33_EC_EC_002 | ABC | EC | ABC3001 | 2 | INJ2 | V3 | DRUG X | Y | Y | 5 | mL | INJECTION | ONCE | SUBCUTANEOUS | ABDOMEN | CENTER | 3 | VISIT 3 | TREATMENT | 2009-05-10 | 2009-05-10 | 21 | 21 | |
| IG33_EC_EC_002 | ABC | EC | ABC3001 | 3 | INJ3 | V3 | DRUG X | Y | Y | 5 | mL | INJECTION | ONCE | SUBCUTANEOUS | ABDOMEN | RIGHT | 3 | VISIT 3 | TREATMENT | 2009-05-10 | 2009-05-10 | 21 | 21 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECDOSFRQ | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_003 | ABC | EC | ABC4001 | 1 | BOTTLE A | Y | Y | 1 | TABLET | QD | TREATMENT | 2011-01-14 | 2011-01-28 | 1 | 15 | |
| IG33_EC_EC_003 | ABC | EC | ABC4001 | 2 | BOTTLE C | Y | Y | 1 | TABLET | QD | TREATMENT | 2011-01-14 | 2011-01-28 | 1 | 15 | |
| IG33_EC_EC_003 | ABC | EC | ABC4001 | 3 | BOTTLE B | Y | Y | 1 | TABLET | QD | TREATMENT | 2011-01-14 | 2011-01-20 | 1 | 7 | |
| IG33_EC_EC_003 | ABC | EC | ABC4001 | 4 | BOTTLE B | Y | N | TABLET | QD | TREATMENT | 2011-01-21 | 2011-01-21 | 8 | 8 | ||
| IG33_EC_EC_003 | ABC | EC | ABC4001 | 5 | BOTTLE B | Y | Y | 2 | TABLET | QD | TREATMENT | 2011-01-22 | 2011-01-22 | 9 | 9 | |
| IG33_EC_EC_003 | ABC | EC | ABC4001 | 6 | BOTTLE B | Y | Y | 1 | TABLET | QD | TREATMENT | 2011-01-23 | 2011-01-28 | 10 | 15 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECLNKID | ECTRT | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECDOSFRQ | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY | ECTPT | ECTPTNUM |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_005 | ABC | EC | ABC5001 | 1 | 20120101-20120108-AM | BOTTLE A | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-01-01 | 2012-01-08 | 1 | 8 | AM | 1 | |
| IG33_EC_EC_005 | ABC | EC | ABC5001 | 2 | 20120101-20120108-PM | BOTTLE B | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-01-01 | 2012-01-08 | 1 | 8 | PM | 2 | |
| IG33_EC_EC_005 | ABC | EC | ABC5002 | 1 | 20120201-20120208-AM | BOTTLE A | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-02-01 | 2012-02-08 | 1 | 8 | AM | 1 | |
| IG33_EC_EC_005 | ABC | EC | ABC5002 | 2 | 20120201-20120208-PM | BOTTLE B | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-02-01 | 2012-02-08 | 1 | 8 | PM | 2 | |
| IG33_EC_EC_005 | ABC | EC | ABC5003 | 1 | 20120301-20120308-AM | BOTTLE A | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-03-01 | 2012-03-08 | 1 | 8 | AM | 1 | |
| IG33_EC_EC_005 | ABC | EC | ABC5003 | 2 | 20120301-20120308-PM | BOTTLE B | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-03-01 | 2012-03-08 | 1 | 8 | PM | 2 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECDOSFRM | ECDOSFRQ | ECROUTE | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY | ECTPT | ECELTM | ECTPTREF |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 1 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-01T07:30 | 2002-07-01T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 2 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-01T07:30 | 2002-07-01T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 3 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-02T07:30 | 2002-07-02T07:30 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 4 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-02T07:30 | 2002-07-02T07:30 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 5 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-03T07:32 | 2002-07-03T07:32 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 6 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-03T07:32 | 2002-07-03T07:32 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 7 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-09T07:30 | 2002-07-09T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 8 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-09T07:30 | 2002-07-09T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 9 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-10T07:30 | 2002-07-10T07:30 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 10 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-10T07:30 | 2002-07-10T07:30 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 11 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-11T07:34 | 2002-07-11T07:34 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789001 | 12 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-11T07:34 | 2002-07-11T07:34 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 1 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-03T07:30 | 2002-07-03T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 2 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-03T07:30 | 2002-07-03T07:30 | 1 | 1 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 3 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-04T07:24 | 2002-07-04T07:24 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 4 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-04T07:24 | 2002-07-04T07:24 | 2 | 2 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 5 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 1 | 2002-07-05T07:24 | 2002-07-05T07:24 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 6 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 1 | 2002-07-05T07:24 | 2002-07-05T07:24 | 3 | 3 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 7 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-11T07:30 | 2002-07-11T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 8 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-11T07:30 | 2002-07-11T07:30 | 9 | 9 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 9 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-12T07:43 | 2002-07-12T07:43 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 10 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-12T07:43 | 2002-07-12T07:43 | 10 | 10 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 11 | BOTTLE 1 | Y | Y | 1 | CAPSULE | CAPSULE | QD | ORAL | TREATMENT 2 | 2002-07-13T07:38 | 2002-07-13T07:38 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST | |
| IG33_EC_EC_006 | 56789 | EC | 56789003 | 12 | BOTTLE 2 | Y | Y | 1 | TABLET, COATED | TABLET, COATED | QD | ORAL | TREATMENT 2 | 2002-07-13T07:38 | 2002-07-13T07:38 | 11 | 11 | 30 MINUTES PRIOR | -PT30M | STD BREAKFAST |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECLNKID | ECLNKGRP | ECTRT | ECMOOD | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECPSTRG | ECPSTRGU | ECADJ | VISITNUM | VISIT | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_007 | ABC123 | EC | ABC123-0201 | 1 | V1 | DRUG Z | SCHEDULED | 10 | mg/kg | 1 | VISIT 1 | TREATMENT | 2009-02-13 | 2009-02-13 | 1 | 1 | |||||||
| IG33_EC_EC_007 | ABC123 | EC | ABC123-0201 | 2 | 20090213 T1000 | V1 | DRUG Z | PERFORMED | Y | Y | 99 | mL | 5.5 | mg/mL | 1 | VISIT 1 | TREATMENT | 2009-02-13T10:00 | 2009-02-13T10:45 | 1 | 1 | ||
| IG33_EC_EC_007 | ABC123 | EC | ABC123-0201 | 3 | V2 | DRUG Z | SCHEDULED | 7.5 | mg/kg | Dose limiting toxicity | 2 | VISIT 2 | TREATMENT | 2009-02-20 | 2009-02-20 | 8 | 8 | ||||||
| IG33_EC_EC_007 | ABC123 | EC | ABC123-0201 | 4 | 20090220 T1100 | V2 | DRUG Z | PERFORMED | Y | Y | 35 | mL | 4.12 | mg/mL | 2 | VISIT 2 | TREATMENT | 2009-02-20T11:00 | 2009-02-20T11:20 | 8 | 8 | ||
| IG33_EC_EC_007 | ABC123 | EC | ABC123-0201 | 5 | V3 | DRUG Z | SCHEDULED | 7.5 | mg/kg | 3 | VISIT 3 | TREATMENT | 2009-02-27 | 2009-02-27 | 15 | 15 | |||||||
| IG33_EC_EC_007 | ABC123 | EC | ABC123-0201 | 6 | 20090227 | V3 | DRUG Z | PERFORMED | Y | N | mL | 4.12 | mg/mL | 3 | VISIT 3 | TREATMENT | 2009-02-27 | 2009-02-27 | 15 | 15 |
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| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECCAT | ECPRESP | ECOCCUR | ECDOSE | ECDOSU | ECDOSFRQ | EPOCH | ECSTDTC | ECENDTC | ECSTDY | ECENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_EC_EC_008 | ABC | EC | ABC7001 | 1 | BOTTLE A | FIRST TO LAST DOSE INTERVAL | Y | Y | 1 | TABLET | QD | TREATMENT | 2012-01-13 | 2012-01-20 | 1 | 8 | |
| IG33_EC_EC_008 | ABC | EC | ABC7001 | 2 | BOTTLE A | EXCEPTION DOSE | Y | N | TABLET | QD | TREATMENT | 2012-01-15 | 2012-01-15 | 3 | 3 | ||
| IG33_EC_EC_008 | ABC | EC | ABC7001 | 3 | BOTTLE A | EXCEPTION DOSE | Y | Y | 2 | TABLET | QD | TREATMENT | 2012-01-16 | 2012-01-16 | 4 | 4 |