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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 where collected using free-text. This CRF was designed to allow the sponsor to use either AEENRF or AEENRTPT to represent an event that was ongoing. This SDTM dataset used MHENRTPT. More information can be found in the section Use of Relative Timing Variables (Copy)
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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 ongoing events. . More information can be found in SDTMIG 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 eventsSection 4.4.7, Use of Relative Timing Variables.
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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, 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 |
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| N | PRODUCT EXPOSURE | 20052006-10-13T13:05 | 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 |
| Y | PRODUCT EXPOSURE | 20052006-1002-2126 |
| 912 |
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