AEs were coded using MedDRA, and the applicant’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 product exposure. Three AEs were reported for this subject. This SDTM dataset used AEENRF to represent ongoing events. Expected variables (e.g., AELLT, AELLTCD, AEPT, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLCTCD, AEBDSYCD, AESOC, AESOCCD) are not included to save space.
The applicant also collected information about whether the event was associated with a device. These subjects did not have any device-related issues. See Section 3.3.3.4, Tobacco Product Events and Malfunctions, for an example of device-related events.
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| Rowcaps |
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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 product was started; the AE start and end times, as well as dates, were collected to allow comparison of the AE timing to the start of product. | | 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. | |
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| Row | STUDYID | DOMAIN | SPDEVID | USUBJID | AESEQ | AETERM | AEMODIFY | AEDECOD | AEBODSYS | AESEV | AESER | AEACN | AEACNDEV | AEREL | AERLDEV | AEOUT | AESCONG | AESDISAB | AESDTH | AESHOSP | AESLIFE | AESMIE | AECONTRT | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY | AEENRF |
|---|
| 1 | ABC123 | AE |
| ABC123-0001 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | NOT APPLICABLE |
| DEFINITELY NOT RELATED |
| RECOVERED/RESOLVED |
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| Y | PRODUCT EXPOSURE | 2006-10-14 | 2006-10-18 | 2 | 5 |
| | 2 | ABC123 | AE |
| ABC123-0001 | 2 | BACK PAIN FOR 6 HOURS | BACK PAIN | Back pain | Musculoskeletal and connective tissue disorders | MODERATE | N | DOSE REDUCED |
| PROBABLY RELATED |
| RECOVERED/RESOLVED |
|
|
|
|
|
| N | PRODUCT EXPOSURE | 2006-10-13T13:05 | 2006-10-13T19:00 | 1 | 1 |
| | 3 | ABC123 | AE |
| ABC123-0002 | 1 | INFLUENZA | Influenza | Influenza | Infections and infestations | SEVERE | Y | PRODUCT WITHDRAWN |
| PROBABLY NOT RELATED |
| RECOVERING/RESOLVING |
|
|
| Y | Y |
| Y | PRODUCT EXPOSURE | 2006-02-26 |
| 12 |
| AFTER |
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|