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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127024711 | 12702471 | 1 | I | 2016 | 20160610 | 20160831 | 20160831 | PER | US-JNJFOC-20160620388 | JANSSEN | 65.82 | YR | E | F | Y | 0.00000 | 20160831 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127024711 | 12702471 | 1 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | Y | N | 20505 | 100 | MG | TABLETS | QD | |||||
| 127024711 | 12702471 | 2 | SS | BACLOFEN. | BACLOFEN | 1 | Oral | Y | 0 | 10 | MG | UNSPECIFIED | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127024711 | 12702471 | 1 | Neuralgia |
| 127024711 | 12702471 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127024711 | 12702471 | Nervousness | |
| 127024711 | 12702471 | Off label use | |
| 127024711 | 12702471 | Product use issue | |
| 127024711 | 12702471 | Rash | |
| 127024711 | 12702471 | Spinal osteoarthritis |
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 |
|---|---|---|---|---|---|---|
| 127024711 | 12702471 | 1 | 20160229 | 20160526 | 0 | |
| 127024711 | 12702471 | 2 | 20160229 | 20160526 | 0 |