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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102488948 | 10248894 | 8 | F | 20150619 | 20140620 | 20150630 | EXP | US-JNJFOC-20140612508 | JANSSEN | 0.00 | M | Y | 0.00000 | 20150630 | N | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102488948 | 10248894 | 1 | SS | TOPAMAX | TOPIRAMATE | 1 | Transplacental | PARENT DOSING | N | 0 | 100 | MG | TABLETS | BID | |||||
| 102488948 | 10248894 | 2 | SS | TOPAMAX | TOPIRAMATE | 1 | Transplacental | PARENT DOSING | N | 0 | 100 | MG | TABLETS | BID | |||||
| 102488948 | 10248894 | 3 | PS | TOPAMAX | TOPIRAMATE | 1 | Transplacental | PARENT DOSING | N | 20505 | 100 | MG | TABLETS | BID | |||||
| 102488948 | 10248894 | 4 | SS | AXERT | ALMOTRIPTAN MALATE | 1 | Transplacental | D | 0 | UNSPECIFIED | |||||||||
| 102488948 | 10248894 | 5 | SS | PHENERGAN | PROMETHAZINE HYDROCHLORIDE | 1 | Transplacental | D | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102488948 | 10248894 | 1 | Seizure |
| 102488948 | 10248894 | 2 | Migraine |
| 102488948 | 10248894 | 3 | Generalised tonic-clonic seizure |
| 102488948 | 10248894 | 4 | Generalised tonic-clonic seizure |
| 102488948 | 10248894 | 5 | Nausea |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102488948 | 10248894 | CA |
| 102488948 | 10248894 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102488948 | 10248894 | Cleft lip and palate | |
| 102488948 | 10248894 | Foetal exposure during pregnancy | |
| 102488948 | 10248894 | Otitis media | |
| 102488948 | 10248894 | Velopharyngeal incompetence |
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 |
|---|---|---|---|---|---|---|
| 102488948 | 10248894 | 1 | 200409 | 201011 | 0 | |
| 102488948 | 10248894 | 2 | 200409 | 201011 | 0 | |
| 102488948 | 10248894 | 3 | 200409 | 201011 | 0 |