The AE domain includes clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms.
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Outstanding Issues - The standard SDTM uses the term study treatment for several variables ( AEREL, AEACN. Should this be changes to study product (or another term).
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This is an example of a CRF used to collect all adverse experiences that occurred after informed consent is obtained. Adverse experiences were collect using free-text.
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This SDTM dataset illustrates data collected on the example AE CRF above, AEs were coded using MedDRA, and the sponsor’s 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 study treatmentproduct 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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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 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 treatmentproduct. | 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 | 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 |
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1 | ABC123 | AE123101 |
| ABC123-0001 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | NOT APPLICABLE |
| DEFINITELY NOT RELATED |
| RECOVERED/RESOLVED | SCREENING |
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| Y | PRODUCT EXPOSURE | 20062005-10-12142005 | 2006-10-1218-1 | 2 | -15 |
| 2 | ABC123 | AE123101 |
| 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 | TREATMENT |
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| N | PRODUCT EXPOSURE | 20062005-10-13T13:05 | 20052006-10-13T19:00 | 1 | 1 |
| 3 | ABC123 | AE | 123101 | 3 | PULMONARY EMBOLISM | Pulmonary embolism | Vascular disorders | MODERATE | Y |
| ABC123-0002 | 1 | INFLUENZA | Influenza | Influenza | Infections and infestations | SEVERE | Y | PRODUCT WITHDRAWNDOSE REDUCED |
| PROBABLY NOT RELATED |
| RECOVERING/RESOLVING |
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| Y | Y | TREATMENT | 2005-10-21 |
| Y | PRODUCT EXPOSURE | 2006-02-26 |
| 129 |
| AFTER |
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