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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300072 | 12530007 | 2 | F | 20160621 | 20160706 | 20160706 | EXP | IT-CIPLA LTD.-2011IT00057 | CIPLA | RINALDUZZI S, CIPRIANI AM, ACCORNERO N. TOPIRAMATE AND VISUAL LOSS IN A PATIENT CARRYING A LEBER HEREDITARY OPTIC NEUROPATHY MUTATION. NEUROL SCI. 2012;33:419 TO 421 | 0.00 | Y | 0.00000 | 20160706 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125300072 | 12530007 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 150 MG, BID | N | U | 76343 | 150 | MG | ||||||
| 125300072 | 12530007 | 2 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 800 MG, BID | N | U | 0 | 800 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125300072 | 12530007 | 1 | Temporal lobe epilepsy |
| 125300072 | 12530007 | 2 | Temporal lobe epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125300072 | 12530007 | OT |
| 125300072 | 12530007 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125300072 | 12530007 | Hepatic enzyme increased | |
| 125300072 | 12530007 | Hereditary optic atrophy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |