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IG33_EC_EC_001 IG33_EC_EC_002 IG33_EC_EC_003 IG33_EC_EC_005 IG33_EC_EC_006 IG33_EC_EC_007 IG33_EC_EC_008 IG33_EC_EX_001 IG33_EC_EX_002 IG33_EC_EX_003 IG33_EC_EX_005 IG33_EC_EX_006 IG33_EC_EX_007 IG33_EC_EX_008 IG33_EC_FA_007 IG33_EC_RELREC_001 IG33_EC_RELREC_002 IG33_EC_RELREC_005 IG33_EC_RELREC_007 IG33_EC_SUPPEC_001 IG33_EC_SUPPEC_007
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example 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
Example STUDYID DOMAIN USUBJID FASEQ FALNKID FATESTCD FATEST FAOBJ FAORRES FAORRESU FASTRESC FASTRESN FASTRESU VISITNUM VISIT EPOCH
IG33_EC_FA_007 ABC123 FA ABC123-0201 1 20090213T1000 DOSEALT Dose in Alternative Unit DRUG Z 522.5 mg 522.5 522.5 mg 1 VISIT 1 TREATMENT
IG33_EC_FA_007 ABC123 FA ABC123-0201 2 20090220T1100 DOSEALT Dose in Alternative Unit DRUG Z 144.2 mg 144.2 144.2 mg 2 VISIT 2 TREATMENT
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_EC_RELREC_001 ABC EC ECLNKID ONE 1
IG33_EC_RELREC_001 ABC EX EXLNKID ONE 1
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_EC_RELREC_002 ABC EC ECLNKID MANY 1
IG33_EC_RELREC_002 ABC EX EXLNKID ONE 1
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_EC_RELREC_005 ABC EC ECLNKID ONE 1
IG33_EC_RELREC_005 ABC EX EXLNKID ONE 1
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_EC_RELREC_007 ABC123 EC ECLNKID ONE 1
IG33_EC_RELREC_007 ABC123 EX EXLNKID ONE 1
IG33_EC_RELREC_007 ABC123 EC ECLNKGRP MANY 2
IG33_EC_RELREC_007 ABC123 EX EXLNKGRP ONE 2
IG33_EC_RELREC_007 ABC123 EX EXLNKID ONE 3
IG33_EC_RELREC_007 ABC123 FA FALNKID ONE 3
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
IG33_EC_SUPPEC_001 ABC EC ABC2001 ECSEQ 2 ECREASOC Reason for Occur Value PATIENT MISTAKE CRF
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
IG33_EC_SUPPEC_007 ABC EC ABC123-0201 ECSEQ 6 ECREASOC Reason for Occur Value PERSONAL REASON CRF