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IG33_FA_AE_002 IG33_FA_AE_005 IG33_FA_AE_008 IG33_FA_CE_001 IG33_FA_CE_004 IG33_FA_FA_001 IG33_FA_FA_002 IG33_FA_FA_003 IG33_FA_FA_004 IG33_FA_FA_005 IG33_FA_FA_006 IG33_FA_FA_007 IG33_FA_FA_008 IG33_FA_RELREC_001 IG33_FA_RELREC_002 IG33_FA_RELREC_008 IG33_FA_SUPPCE_004 IG33_FA_SUPPFA_004
Example STUDYID DOMAIN USUBJID AESEQ AESPID AETERM AEBODSYS AELOC AELAT AESEV AESER AEACN AESTDTC O
IG33_FA_AE_002 XYZ AE XYZ-789 47869 5 Injection site rash General disorders and administration site conditions ARM LEFT MILD N NOT APPLICABLE 2007-05-10
Example STUDYID DOMAIN USUBJID AESEQ AETERM AEDECOD AEPRESP AEBODSYS AESEV AEACN EPOCH AESTDTC AEENDTC
IG33_FA_AE_005 QRS AE 1234 1 Headache Headache Y Nervous system disorders MILD NONE TREATMENT 2005-09-30
IG33_FA_AE_005 QRS AE 1234 2 Nausea Nausea Y Gastrointestinal disorders MODERATE NONE TREATMENT 2005-10-08 2005-10-09
Example DOMAIN USUBJID AESEQ AETERM AEDECOD AESEV AESTDTC AEENDTC
IG33_FA_AE_008 AE 123 1 Morning queasiness Nausea MODERATE 2006-02-01 2006-02-23
IG33_FA_AE_008 AE 123 2 Watery stools Diarrhea MILD 2006-02-012006-02-15
Example STUDYID DOMAIN USUBJID CESEQ CESPID CETERM CEDECOD CESTDTC
IG33_FA_CE_001 ABC CE ABC-123 1 90567 Migraine Migraine 2007-05-16T10:30
Example STUDYID DOMAIN USUBJID CESEQ CESPID CETERM CELOC CEOUT CECONTRT CESTDTC
IG33_FA_CE_004 ABC CE ABC -US-701-002 1 1 Fracture ARM NORMAL HEALING Y 2006-07-03
IG33_FA_CE_004 ABC CE ABC -US-701-002 2 2 Fracture LEG COMPLICATIONS N 2006-10-15
Example STUDYID DOMAIN USUBJID FASEQ FASPID FATESTCD FATEST FAOBJ FACAT FAORRES FASTRESC FADTC FATPT FAELTM FATPTREF
IG33_FA_FA_001 ABC FA ABC-123 1 90567 SEV Severity/Intensity Migraine MIGRAINE SYMPTOMS SEVERE SEVERE 2007-05-16 5M PRE-DOSE -PT5M DOSING
IG33_FA_FA_001 ABC FA ABC-123 2 90567 OCCUR Occurrence Sensitivity To Light MIGRAINE SYMPTOMS Y Y 2007-05-16 5M PRE-DOSE -PT5M DOSING
IG33_FA_FA_001 ABC FA ABC-123 3 90567 OCCUR Occurrence Sensitivity To Sound MIGRAINE SYMPTOMS N N 2007-05-16 5M PRE-DOSE -PT5M DOSING
IG33_FA_FA_001 ABC FA ABC-123 4 90567 OCCUR Occurrence Nausea MIGRAINE SYMPTOMS Y Y 2007-05-16 5M PRE-DOSE -PT5M DOSING
IG33_FA_FA_001 ABC FA ABC-123 6 90567 OCCUR Occurrence Aura MIGRAINE SYMPTOMS Y Y 2007-05-16 5M PRE-DOSE -PT5M DOSING
IG33_FA_FA_001 ABC FA ABC-123 7 90567 SEV Severity/Intensity Migraine MIGRAINE SYMPTOMS MODERATE MODERATE 2007-05-16 30M POST-DOSE PT30M DOSING
IG33_FA_FA_001 ABC FA ABC-123 8 90567 OCCUR Occurrence Sensitivity To Light MIGRAINE SYMPTOMS Y Y 2007-05-16 30M POST-DOSE PT30M DOSING
IG33_FA_FA_001 ABC FA ABC-123 9 90567 OCCUR Occurrence Sensitivity To Sound MIGRAINE SYMPTOMS N N 2007-05-16 30M POST-DOSE PT30M DOSING
IG33_FA_FA_001 ABC FA ABC-123 10 90567 OCCUR Occurrence Nausea MIGRAINE SYMPTOMS N N 2007-05-16 30M POST-DOSE PT30M DOSING
IG33_FA_FA_001 ABC FA ABC-123 12 90567 OCCUR Occurrence Aura MIGRAINE SYMPTOMS Y Y 2007-05-16 30M POST-DOSE PT30M DOSING
IG33_FA_FA_001 ABC FA ABC-123 13 90567 SEV Severity/Intensity Migraine MIGRAINE SYMPTOMS MILD MILD 2007-05-16 90M POST-DOSE PT90M DOSING
IG33_FA_FA_001 ABC FA ABC-123 14 90567 OCCUR Occurrence Sensitivity To Light MIGRAINE SYMPTOMS N N 2007-05-16 90M POST-DOSE PT90M DOSING
IG33_FA_FA_001 ABC FA ABC-123 15 90567 OCCUR Occurrence Sensitivity To Sound MIGRAINE SYMPTOMS N N 2007-05-16 90M POST-DOSE PT90M DOSING
IG33_FA_FA_001 ABC FA ABC-123 16 90567 OCCUR Occurrence Nausea MIGRAINE SYMPTOMS N N 2007-05-16 90M POST-DOSE PT90M DOSING
IG33_FA_FA_001 ABC FA ABC-123 18 90567 OCCUR Occurrence Aura MIGRAINE SYMPTOMS N N 2007-05-16 90M POST-DOSE PT90M DOSING
Example STUDYID DOMAIN USUBJID FASEQ FASPID FATESTCD FATEST FAOBJ FAORRES FAORRESU FASTRESC FASTRESU VISITNUM EPOCH FADTC
IG33_FA_FA_002 XYZ FA XYZ-789 123451 5 DIAM Diameter Injection Site Rash 2.5 IN 2.5 IN 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123452 5 COUNT Count Macules 26 to 100 26 to 100 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123453 5 COUNT Count Papules 1 to 25 1 to 25 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123454 5 COUNT Count Vesicles 0 0 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123455 5 COUNT Count Pustules 0 0 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123456 5 COUNT Count Scabs 0 0 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123457 5 COUNT Count Scars 0 0 3 TREATMENT 2007-05-12
IG33_FA_FA_002 XYZ FA XYZ-789 123459 5 DIAM Diameter Injection Site Rash 1 IN 1 IN 4 TREATMENT 2007-05-19
IG33_FA_FA_002 XYZ FA XYZ-789 123460 5 COUNT Count Macules 1 to 25 1 to 25 4 TREATMENT 2007-05-19
IG33_FA_FA_002 XYZ FA XYZ-789 123461 5 COUNT Count Papules 1 to 25 1 to 25 4 TREATMENT 2007-05-19
IG33_FA_FA_002 XYZ FA XYZ-789 123462 5 COUNT Count Vesicles 0 0 4 TREATMENT 2007-05-19
IG33_FA_FA_002 XYZ FA XYZ-789 123463 5 COUNT Count Pustules 0 0 4 TREATMENT 2007-05-19
IG33_FA_FA_002 XYZ FA XYZ-789 123464 5 COUNT Count Scabs 0 0 4 TREATMENT 2007-05-19
IG33_FA_FA_002 XYZ FA XYZ-789 123465 5 COUNT Count Scars 0 0 4 TREATMENT 2007-05-19
Example STUDYID DOMAIN USUBJID FASEQ FATESTCD FATEST FAOBJ FACAT FAORRES FASTRESC FADTC FAEVLINT
IG33_FA_FA_003 ABC FA ABC-123 1 SEV Severity/Intensity Joint Stiffness RHEUMATOID ARTHRITIS HISTORY SEVERE SEVERE 2006-08-13 -P6M
IG33_FA_FA_003 ABC FA ABC-123 2 SEV Severity/Intensity Inflammation RHEUMATOID ARTHRITIS HISTORY MODERATE MODERATE 2006-08-13 -P6M
IG33_FA_FA_003 ABC FA ABC-123 3 SEV Severity/Intensity Joint Swelling RHEUMATOID ARTHRITIS HISTORY MODERATE MODERATE 2006-08-13 -P6M
IG33_FA_FA_003 ABC FA ABC-123 4 SEV Severity/Intensity Arthralgia RHEUMATOID ARTHRITIS HISTORY MODERATE MODERATE 2006-08-13 -P6M
IG33_FA_FA_003 ABC FA ABC-123 5 SEV Severity/Intensity Malaise RHEUMATOID ARTHRITIS HISTORY MILD MILD 2006-08-13 -P6M
IG33_FA_FA_003 ABC FA ABC-123 6 DUR Duration Early Morning Stiffness RHEUMATOID ARTHRITIS HISTORY PT1H30M PT1H30M 2006-08-13 -P6M
Example STUDYID DOMAIN USUBJID FASEQ FASPID FATESTCD FATEST FAOBJ FACAT FAORRES FADTC
IG33_FA_FA_004 ABC FA ABC -US-701-002 1 798654 REAS Reason Bone Fracture BONE FRACTURE ASSESSMENT - HISTORY FALL 2006-04-10
IG33_FA_FA_004 ABC FA ABC -US-701-002 2 798654 OUT Outcome Bone Fracture BONE FRACTURE ASSESSMENT - HISTORY COMPLICATIONS 2006-04-10
IG33_FA_FA_004 ABC FA ABC -US-701-002 3 798654 OCCUR Occurrence Complications BONE FRACTURE ASSESSMENT Y 2006-04-10
IG33_FA_FA_004 ABC FA ABC -US-701-002 4 798654 OCCUR Occurrence Therapeutic Measure BONE FRACTURE ASSESSMENT Y 2006-04-10
Example STUDYID DOMAIN USUBJID FASEQ FATESTCD FATEST FAOBJ FAORRES FASTRESC FASTAT VISITNUM VISIT EPOCH FADTC
IG33_FA_FA_005 QRS FA 1234 1 OCCUR Occurrence Headache Y Y 2 VISIT 2 TREATMENT 2005-10-01
IG33_FA_FA_005 QRS FA 1234 2 OCCUR Occurrence Respiratory Infection N N 2 VISIT 2 TREATMENT 2005-10-01
IG33_FA_FA_005 QRS FA 1234 3 OCCUR Occurrence Nausea NOT DONE 2 VISIT 2 TREATMENT 2005-10-01
IG33_FA_FA_005 QRS FA 1234 4 OCCUR Occurrence Headache Y Y 3 VISIT 3 TREATMENT 2005-10-10
IG33_FA_FA_005 QRS FA 1234 5 OCCUR Occurrence Respiratory Infection N N 3 VISIT 3 TREATMENT 2005-10-10
IG33_FA_FA_005 QRS FA 1234 6 OCCUR Occurrence Nausea Y Y 3 VISIT 3 TREATMENT 2005-10-10
Example STUDYID DOMAIN USUBJID FASEQ FATESTCD FATEST FAOBJ FACAT FAORRES FAORRESU FASTRESC FASTRESU FASTAT VISITNUM VISIT FADTC
IG33_FA_FA_006 XYZ FA XYZ-701-002 1 VOL Volume Vomit GERD 250 mL 250 mL 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 2 NUMEPISD Number of Episodes Vomit GERD >10 >10 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 3 SEV Severity/Intensity Vomit GERD SEVERE SEVERE 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 4 NUMEPISD Number of Episodes Diarrhea GERD 2 2 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 5 SEV Severity/Intensity Diarrhea GERD SEVERE SEVERE 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 6 NUMEPISD Number of Episodes Nausea GERD 1 1 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 7 SEV Severity/Intensity Nausea GERD MODERATE MODERATE 1 VISIT 1 2006-02-02
IG33_FA_FA_006 XYZ FA XYZ-701-002 8 VOL Volume Vomit GERD 0 mL 0 mL 2 VISIT 2 2006-02-03
IG33_FA_FA_006 XYZ FA XYZ-701-002 9 NUMEPISD Number of Episodes Vomit GERD 0 0 2 VISIT 2 2006-02-03
IG33_FA_FA_006 XYZ FA XYZ-701-002 10 SEV Severity/Intensity Vomit GERD NONE NONE 2 VISIT 2 2006-02-03
IG33_FA_FA_006 XYZ FA XYZ-701-002 11 NUMEPISD Number of Episodes Diarrhea GERD 1 1 2 VISIT 2 2006-02-03
IG33_FA_FA_006 XYZ FA XYZ-701-002 12 SEV Severity/Intensity Diarrhea GERD SEVERE SEVERE 2 VISIT 2 2006-02-03
IG33_FA_FA_006 XYZ FA XYZ-701-002 13 NUMEPISD Number of Episodes Nausea GERD NOT DONE 2 VISIT 2 2006-02-03
IG33_FA_FA_006 XYZ FA XYZ-701-002 14 SEV Severity/Intensity Nausea GERD NOT DONE 2 VISIT 2 2006-02-03
Example STUDYID DOMAIN USUBJID FASEQ FATESTCD FATEST FAOBJ FACAT FAORRES FAORRESU FASTRESC FASTRESU FASTAT VISITNUM EPOCH FADTC
IG33_FA_FA_007 XYZ FA XYZ-701-002 1 OCCUR Occurrence Vomit GERD Y Y 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 2 VOL Volume Vomit GERD 250 mL 250 mL 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 3 NUMEPISD Number of Episodes Vomit GERD >10 >10 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 4 SEV Severity/Intensity Vomit GERD SEVERE SEVERE 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 5 OCCUR Occurrence Diarrhea GERD Y Y 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 6 NUMEPISD Number of Episodes Diarrhea GERD 2 2 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 7 SEV Severity/Intensity Diarrhea GERD SEVERE SEVERE 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 8 OCCUR Occurrence Nausea GERD Y Y 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 9 NUMEPISD Number of Episodes Nausea GERD 1 1 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 10 SEV Severity/Intensity Nausea GERD MODERATE MODERATE 1 SCREENING 2006-02-02
IG33_FA_FA_007 XYZ FA XYZ-701-002 11 OCCUR Occurrence Vomit GERD N N 2 TREATMENT 2006-02-03
IG33_FA_FA_007 XYZ FA XYZ-701-002 12 OCCUR Occurrence Diarrhea GERD Y Y 2 TREATMENT 2006-02-03
IG33_FA_FA_007 XYZ FA XYZ-701-002 13 NUMEPISD Number of Episodes Diarrhea GERD 1 1 2 TREATMENT 2006-02-03
IG33_FA_FA_007 XYZ FA XYZ-701-002 14 SEV Severity/Intensity Diarrhea GERD SEVERE SEVERE 2 TREATMENT 2006-02-03
IG33_FA_FA_007 XYZ FA XYZ-701-002 15 OCCUR Occurrence Nausea GERD NOT DONE 2 TREATMENT 2006-02-03
Example STUDYID DOMAIN USUBJID FASEQ FATESTCD FATEST FAOBJ FAORRES VISITNUM VISIT FADTC
IG33_FA_FA_008 XYZ FA XYZ-US-701-002 1 SEV Severity/Intensity Nausea MILD 2 VISIT 2 2006-02-02
IG33_FA_FA_008 XYZ FA XYZ-US-701-002 2 SEV Severity/Intensity Nausea MODERATE 3 VISIT 3 2006-02-09
IG33_FA_FA_008 XYZ FA XYZ-US-701-002 3 SEV Severity/Intensity Nausea MODERATE 4 VISIT 4 2006-02-16
IG33_FA_FA_008 XYZ FA XYZ-US-701-002 4 SEV Severity/Intensity Nausea MILD 5 VISIT 5 2006-02-23
IG33_FA_FA_008 XYZ FA XYZ-US-701-002 5 SEV Severity/Intensity Diarrhea MILD 2 VISIT 2 2006-02-02
IG33_FA_FA_008 XYZ FA XYZ-US-701-002 6 SEV Severity/Intensity Diarrhea MILD 3 VISIT 3 2006-02-09
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_FA_RELREC_001 ABC CE CESPID ONE 1
IG33_FA_RELREC_001 ABC FA FASPID MANY 1
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_FA_RELREC_002 XYZ AE AESPID ONE 23
IG33_FA_RELREC_002 XYZ FA FASPID MANY 23
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID
IG33_FA_RELREC_008 ABC AE XYZ-US-701-002 AESEQ 1 1
IG33_FA_RELREC_008 ABC FA XYZ-US-701-002 FASEQ 1 1
IG33_FA_RELREC_008 ABC FA XYZ-US-701-002 FASEQ 2 1
IG33_FA_RELREC_008 ABC FA XYZ-US-701-002 FASEQ 3 1
IG33_FA_RELREC_008 ABC FA XYZ-US-701-002 FASEQ 4 1
IG33_FA_RELREC_008 ABC AE XYZ-US-701-002 AESEQ 2 2
IG33_FA_RELREC_008 ABC FA XYZ-US-701-002 FASEQ 5 2
IG33_FA_RELREC_008 ABC FA XYZ-US-701-002 FASEQ 6 2
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
IG33_FA_SUPPCE_004 ABC CE ABC -US-701-002 CESPID 1 REAS Reason FALL CRF
IG33_FA_SUPPCE_004 ABC CE ABC -US-701-002 CESPID 2 REAS Reason OTHER TRAUMA CRF
IG33_FA_SUPPCE_004 ABC CE ABC -US-701-002 CESPID 2 OUT Outcome COMPLICATIONS CRF
Example STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL
IG33_FA_SUPPFA_004 ABC FA ABC -US-701-002 FASEQ 1 FATYP FA Type MOST RECENT CRF
IG33_FA_SUPPFA_004 ABC FA ABC -US-701-002 FASEQ 2 FATYP FA Type MOST RECENT CRF
IG33_FA_SUPPFA_004 ABC FA ABC -US-701-002 FASEQ 3 FATYP FA Type MOST RECENT CRF
IG33_FA_SUPPFA_004 ABC FA ABC -US-701-002 FASEQ 4 FATYP FA Type MOST RECENT CRF