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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127825661 | 12782566 | 1 | I | 20160814 | 0 | 20160926 | 20160926 | DIR | US-FDA-351539 | FDA-CTU | 26.00 | YR | F | N | 72.00000 | KG | 20160926 | N | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127825661 | 12782566 | 1 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | Y | D | 0 | 4 | DF | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127825661 | 12782566 | 1 | Migraine prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127825661 | 12782566 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127825661 | 12782566 | Abdominal discomfort | |
| 127825661 | 12782566 | Activities of daily living impaired | |
| 127825661 | 12782566 | Anxiety | |
| 127825661 | 12782566 | Chest pain | |
| 127825661 | 12782566 | Claustrophobia | |
| 127825661 | 12782566 | Conversion disorder | |
| 127825661 | 12782566 | Crying | |
| 127825661 | 12782566 | Depersonalisation/derealisation disorder | |
| 127825661 | 12782566 | Disturbance in attention | |
| 127825661 | 12782566 | Fear of death | |
| 127825661 | 12782566 | Hyperhidrosis | |
| 127825661 | 12782566 | Influenza like illness | |
| 127825661 | 12782566 | Insomnia | |
| 127825661 | 12782566 | Nausea | |
| 127825661 | 12782566 | Palpitations | |
| 127825661 | 12782566 | Panic attack | |
| 127825661 | 12782566 | Paraesthesia | |
| 127825661 | 12782566 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127825661 | 12782566 | 1 | 20160401 | 20160818 | 0 |