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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127024611 | 12702461 | 1 | I | 20160712 | 20160714 | 20160831 | 20160831 | PER | US-JNJFOC-20160712696 | JANSSEN | 39.69 | YR | A | M | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127024611 | 12702461 | 1 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 0 | 75 | MG | TABLETS | |||||||
| 127024611 | 12702461 | 2 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 0 | 100 | MG | TABLETS | |||||||
| 127024611 | 12702461 | 3 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 0 | 50 | MG | TABLETS | |||||||
| 127024611 | 12702461 | 4 | SS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 0 | 50 | MG | TABLETS | |||||||
| 127024611 | 12702461 | 5 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 20505 | 100 | MG | TABLETS | |||||||
| 127024611 | 12702461 | 6 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 127024611 | 12702461 | 7 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Unknown | 0 | 25 | MG | UNSPECIFIED | ||||||||
| 127024611 | 12702461 | 8 | C | IMITREX | SUMATRIPTAN SUCCINATE | 1 | Unknown | 0 | 4 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127024611 | 12702461 | 1 | Cluster headache |
| 127024611 | 12702461 | 2 | Cluster headache |
| 127024611 | 12702461 | 3 | Cluster headache |
| 127024611 | 12702461 | 4 | Cluster headache |
| 127024611 | 12702461 | 5 | Cluster headache |
| 127024611 | 12702461 | 6 | Headache |
| 127024611 | 12702461 | 7 | Sleep disorder |
| 127024611 | 12702461 | 8 | Headache |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127024611 | 12702461 | Anhidrosis | |
| 127024611 | 12702461 | Body temperature increased | |
| 127024611 | 12702461 | Chills | |
| 127024611 | 12702461 | Dizziness | |
| 127024611 | 12702461 | Feeling abnormal | |
| 127024611 | 12702461 | Headache | |
| 127024611 | 12702461 | Heat exhaustion | |
| 127024611 | 12702461 | Insomnia | |
| 127024611 | 12702461 | Paraesthesia | |
| 127024611 | 12702461 | Sedation | |
| 127024611 | 12702461 | Self-medication | |
| 127024611 | 12702461 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 127024611 | 12702461 | 1 | 20160709 | 201607 | 0 | |
| 127024611 | 12702461 | 2 | 20160705 | 20160707 | 0 | |
| 127024611 | 12702461 | 3 | 20160711 | 20160712 | 0 | |
| 127024611 | 12702461 | 4 | 2013 | 0 | ||
| 127024611 | 12702461 | 5 | 2013 | 0 |