Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126343751 | 12634375 | 1 | I | 20150923 | 20151026 | 20160808 | 20160808 | EXP | FR-AFSSAPS-RE20151189 | FR-GLAXOSMITHKLINE-FR2015GSK153235 | GLAXOSMITHKLINE | 17.38 | YR | F | Y | 49.00000 | KG | 20160808 | OT | FR | FR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126343751 | 12634375 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | UNK | Y | 20241 | TABLET | ||||||||
| 126343751 | 12634375 | 2 | SS | DEPAKINE CHRONO | VALPROATE SODIUM | 1 | Oral | UNK | Y | N | 0 | PROLONGED-RELEASE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126343751 | 12634375 | 1 | Juvenile myoclonic epilepsy |
| 126343751 | 12634375 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126343751 | 12634375 | HO |
| 126343751 | 12634375 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126343751 | 12634375 | Drug eruption | |
| 126343751 | 12634375 | Incorrect dose administered | |
| 126343751 | 12634375 | Lymphadenopathy | |
| 126343751 | 12634375 | Pyrexia | |
| 126343751 | 12634375 | Rash morbilliform | |
| 126343751 | 12634375 | Toxic skin eruption |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126343751 | 12634375 | 1 | 201509 | 20151006 | 0 | |
| 126343751 | 12634375 | 2 | 201510 | 0 |