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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119060975 | 11906097 | 5 | F | 201511 | 20160808 | 20160111 | 20160822 | EXP | IT-APOTEX-2015AP015695 | APOTEX | 27.09 | YR | F | Y | 0.00000 | 20160822 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119060975 | 11906097 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Oral | UNK | Y | 77733 | TABLET | ||||||||
| 119060975 | 11906097 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | U | U | 0 | DISPERSIBLE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119060975 | 11906097 | 1 | Partial seizures |
| 119060975 | 11906097 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119060975 | 11906097 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119060975 | 11906097 | Drug ineffective | |
| 119060975 | 11906097 | Epilepsy | |
| 119060975 | 11906097 | Product substitution issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |