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Need to Determine Codes to be used TRIAL INTERVENTION DISCONTINUED or PRODUCT DISCONTINUED
Need to look Up code for MEDDRA SKIN REDNESS
ae.xpt
xx.xpt
| 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 |
|---|
| 1 | A123 | AE |
| A2001 | 1 | POUNDING HEADACHE | HEADACHE | Headache | Nervous system disorders | SEVERE | N | DOSE NOT CHANGED |
| DEFINITELY NOT RELATED |
| RECOVERED/RESOLVED |
|
|
|
|
|
| Y | PRODUCT EXPOSURE | 2021-01-21 | 2021-01-21 | 16 | 16 |
|---|
| 2 | A123 | AE | VAPE-Z01 | A2008 | 1 | SKIN REDNESS | SKIN REDNESS | Skin Redness |
| MODERATE | N | DOSE NOT CHANGED | DEVICE REPLACED | PROBABLY RELATED | RELATED | RECOVERED/RESOLVED |
|
|
|
|
|
| N | PRODUCT EXPOSURE | 2021-02-16 | 2021-02-21 | 8 | 13 |
|---|
| 3 | A123 | AE |
| A3009 | 1 | INFLUENZA | INFLUENZA | Influenza | Infections and infestations | SEVERE | Y | TRIAL INTERVENTION DISCONTINUED |
| PROBABLY NOT RELATED |
| RECOVERING/RESOLVING |
|
|
| Y | Y |
| Y | PRODUCT EXPOSURE | 2021-06-21 | 2021-06-26 | 13 | 18 |
|---|
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