This example illustrates data from an AE CRF that collected AE terms as free text. AEs were coded using MedDRA, and the sponsor’s procedures include the possibility of modifying the reported term to aid in coding. The CRF was structured so that seriousness category variables (e.g., AESDTH, AESHOSP) were checked only when AESER is answered “Y.” In this study, the study reference period started at the start of study treatment. Three AEs were reported for this subject.
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| Rows 1-2: | Show examples of modifying the reported term for coding purposes, with the modified term in AEMODIFY. These adverse events were not serious, so the seriousness criteria variables are null. Note that for the event in row 2, AESTDY = "1". Day 1 was the day treatment started; the AE start and end times, as well as dates, were collected to allow comparison of the AE timing to the start of treatment. | | Row 3: | Shows an example of the overall seriousness question AESER answered with "Y" and the relevant corresponding seriousness category variables (AESHOSP and AESLIFE) answered "Y". The other seriousness category variables are left blank. This row also shows AEENRF being populated because the AE was marked as “Continuing” as of the end of the study reference period for the subject (see Section 4.4.7, Use of Relative Timing Variables). | |
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| Row | 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 |
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| 1 | ABC123 | AE | 123101 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | NOT APPLICABLE | DEFINITELY NOT RELATED | RECOVERED/RESOLVED |
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| SCREENING | 2005-10-12 | 2005-10-12 | -1 | -1 |
| | 2 | 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 |
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| TREATMENT | 2005-10-13T13:05 | 2005-10-13T19:00 | 1 | 1 |
| | 3 | ABC123 | AE | 123101 | 3 | PULMONARY EMBOLISM |
| Pulmonary embolism | Vascular disorders | MODERATE | Y | DOSE REDUCED | PROBABLY NOT RELATED | RECOVERING/RESOLVING |
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| Y | Y |
| TREATMENT | 2005-10-21 |
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