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The sponsor also collected information about whether the event was associated with a Device. This These subject's did not have any device related issues. See Tobacco Product Issues and Events 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 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, 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 | AE |
| ABC123-0001 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | NOT APPLICABLE |
| DEFINITELY NOT RELATED |
| RECOVERED/RESOLVED |
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| YSCREENING | PRODUCT EXPOSURE | 2006-10-1214 | 2006-10-1418-1 | xx | 2xx |
| | 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 |
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| PRODUCT EXPOSURE | 2006-10-13T13:05 | 2006-10-13T19:00 | 1xx1 | x |
| | 3 | ABC123 | AE |
| ABC123-0001 | 3 | PULMONARY EMBOLISM | Pulmonary embolism | Vascular disorders | MODERATE | Y | 0002 | 1 | INFLUENZA | Influenza | Influenza | Infections and
infestations | SEVERE | Y | DRUG WITHDRAWNDOSE REDUCED |
| PROBABLY NOT RELATED |
| RECOVERING/RESOLVING |
|
|
| Y | Y |
| Y | PRODUCT EXPOSURE | 2006-1002-2126 |
| 9xx |
| AFTER |
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