| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | AESEQ | AETERM | AEMODIFY | AEDECOD | AEBODSYS | AESEV | AESER | AEACN | AEREL | AEOUT | AESCONG | AESDISAB | AESDTH | AESHOSP | AESLIFE | AESMIE | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY | AEENRF |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_AE_AE_001 | ABC123 | AE | 123101 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | NOT APPLICABLE | DEFINITELY NOT RELATED | RECOVERED/RESOLVED | SCREENING | 2005-10-12 | 2005-10-12 | -1 | -1 | ||||||||
| IG33_AE_AE_001 | ABC123 | AE | 123101 | 2 | BACK PAIN FOR 6 HOURS | BACK PAIN | Back pain | Musculoskeletal and connective tissue disorders | MODERATE | N | DOSE REDUCED | PROBABLY RELATED | RECOVERED/RESOLVED | TREATMENT | 2005-10-13T13:05 | 2005-10-13T19:00 | 1 | 1 | ||||||||
| IG33_AE_AE_001 | ABC123 | AE | 123101 | 3 | PULMONARY EMBOLISM | Pulmonary embolism | Vascular disorders | MODERATE | Y | DOSE REDUCED | PROBABLY NOT RELATED | RECOVERING/RESOLVING | Y | Y | TREATMENT | 2005-10-21 | 9 | AFTER |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | AESEQ | AETERM | AEDECOD | AEPRESP | AEBODSYS | AESEV | AESER | AEACN | AEREL | AEOUT | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_AE_AE_002 | ABC123 | AE | 123101 | 1 | NAUSEA | Nausea | Y | Gastrointestinal disorders | SEVERE | N | DOSE REDUCED | RELATED | RECOVERED/RESOLVED | TREATMENT | 2005-10-12 | 2005-10-13 | 2 | 3 | |
| IG33_AE_AE_002 | ABC123 | AE | 123101 | 2 | VOMITING | Vomiting | Y | Gastrointestinal disorders | MODERATE | N | DOSE REDUCED | RELATED | RECOVERED/RESOLVED | TREATMENT | 2005-10-13T13:00 | 2005-10-13T19:00 | 3 | 3 | |
| IG33_AE_AE_002 | ABC123 | AE | 123101 | 3 | HEADACHE | Headache | Nervous system disorders | MILD | N | DOSE NOT CHANGED | POSSIBLY RELATED | RECOVERED/RESOLVED | TREATMENT | 2005-10-21 | 2005-10-21 | 11 | 11 |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | AESEQ | AETERM | AEDECOD | AEPRESP | AEBODSYS | AESER | AEACN | AEREL | AEDTC | AESTDTC | AEENDTC | AEDY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_AE_AE_003 | ABC123 | AE | 123101 | 1 | NAUSEA | Nausea | Y | Gastrointestinal disorders | 2005-10-29 | 19 | ||||||
| IG33_AE_AE_003 | ABC123 | AE | 123101 | 2 | VOMITING | Vomiting | Y | Gastrointestinal disorders | 2005-10-29 | 19 |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | AESEQ | AEGRPID | AETERM | AEBODSYS | AESEV | AESER | AEACN | AEREL | AESTDTC | AEENDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_AE_AE_004 | ABC123 | AE | 123101 | 1 | NAUSEA | Gastrointestinal disorders | MODERATE | N | DOSE NOT CHANGED | RELATED | 2005-10-13 | 2005-10-14 | ||
| IG33_AE_AE_004 | ABC123 | AE | 123101 | 2 | 1 | VOMITING | Gastrointestinal disorders | MILD | N | DOSE NOT CHANGED | POSSIBLY RELATED | 2005-10-14 | 2005-10-16 | |
| IG33_AE_AE_004 | ABC123 | AE | 123101 | 3 | 1 | VOMITING | Gastrointestinal disorders | SEVERE | N | DOSE NOT CHANGED | POSSIBLY RELATED | 2005-10-16 | 2005-10-17 | |
| IG33_AE_AE_004 | ABC123 | AE | 123101 | 4 | 1 | VOMITING | Gastrointestinal disorders | MILD | N | DOSE NOT CHANGED | POSSIBLY RELATED | 2005-10-17 | 2005-10-20 | |
| IG33_AE_AE_004 | ABC123 | AE | 123101 | 5 | 2 | DIARRHEA | Gastrointestinal disorders | SEVERE | N | DOSE NOT CHANGED | POSSIBLY RELATED | 2005-10-16 | 2005-10-17 | |
| IG33_AE_AE_004 | ABC123 | AE | 123101 | 6 | 2 | DIARRHEA | Gastrointestinal disorders | MODERATE | N | DOSE NOT CHANGED | POSSIBLY RELATED | 2005-10-17 | 2005-10-21 |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | AESEQ | AETERM | AESTDTC | AEENDTC | AEDECOD | AEBODSYS | AEOUT | AESER | AESDTH |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DD_AE_002 | ABC123 | AE | ABC12301001 | 6 | SUDDEN CARDIAC DEATH | 2011-01-10 | 2011-01-10 | SUDDEN CARDIAC DEATH | CARDIOVASCULAR SYSTEM | FATAL | Y | Y |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | AESEQ | AETERM | AESTDTC | AEENDTC | AEDECOD | AESOC | AESEV | AESER | AEACN | AEREL | AEOUT | AESCAN | AESCONG | AESDISAB | AESDTH | AESHOSP | AESLIFE | AESOD | AESMIE |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_DS_AE_004 | ABC123 | AE | 123102 | 1 | Heart Failure | 2003-09-29 | 2003-09-29 | HEART FAILURE | CARDIOVASCULAR SYSTEM | SEVERE | Y | NOT APPLICABLE | DEFINITELY NOT RELATED | FATAL | N | N | N | Y | N | N | N | N |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | 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 |
| Copyright @ www.statschoice.com |
| EXAMPLE_NUM | ROW_DESCRIPTION | STUDYID | DOMAIN | USUBJID | FOCID | AESEQ | AESPID | AETERM | AEDECOD | AEBODSYS | AELOC | AELAT | AESEV | AESER | AEACN | AEREL | AEOUT | AESTDTC | AEENDTC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IG33_OE_AE_004 | XYZ | AE | XYZ-100-0001 | 5 | 1 | Headaches | Headache | Nervous system disorders | MILD | N | DOSE NOT CHANGED | NOT RELATED | RECOVERED/RESOLVED | 2011-05-02 | 2011-05-06 | ||||
| IG33_OE_AE_004 | XYZ | AE | XYZ-100-0001 | OD | 6 | 2 | Worsening Dry Eyes | Dry eye | Eye disorders | EYE | RIGHT | MODERATE | N | DOSE NOT CHANGED | NOT RELATED | RECOVERED/RESOLVED | 2011-05-03 | 2011-05-05 | |
| IG33_OE_AE_004 | XYZ | AE | XYZ-100-0001 | OS | 7 | 2 | Worsening Dry Eyes | Dry eye | Eye disorders | EYE | LEFT | MODERATE | N | DOSE NOT CHANGED | NOT RELATED | RECOVERED/RESOLVED | 2011-05-03 | 2011-05-04 |