Online training class for Clinical R programming batch starts on Monday, 30Jun2025.
Click here for details.
Online training class for Clinical R programming batch starts on Monday, 30Jun2025.
Click here for details.
| Example | 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 |
| Example | 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 |
| Example | 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 |
| Example | 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 |