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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127024581 | 12702458 | 1 | I | 2016 | 20160708 | 20160831 | 20160831 | PER | US-JNJFOC-20160707997 | JANSSEN | 45.90 | YR | A | F | Y | 78.02000 | KG | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127024581 | 12702458 | 1 | PS | TOPAMAX | TOPIRAMATE | 1 | Oral | N | 20505 | 20 | MG | TABLETS | QD | ||||||
| 127024581 | 12702458 | 2 | C | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 127024581 | 12702458 | 3 | C | KLONOPIN | CLONAZEPAM | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 127024581 | 12702458 | 4 | C | KLONOPIN | CLONAZEPAM | 1 | Unknown | 0 | 20 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127024581 | 12702458 | 1 | Migraine prophylaxis |
| 127024581 | 12702458 | 2 | Anxiety |
| 127024581 | 12702458 | 3 | Hypersomnia |
| 127024581 | 12702458 | 4 | Anxiety |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127024581 | 12702458 | Communication disorder | |
| 127024581 | 12702458 | Coordination abnormal | |
| 127024581 | 12702458 | Disturbance in attention | |
| 127024581 | 12702458 | Fall | |
| 127024581 | 12702458 | Memory impairment | |
| 127024581 | 12702458 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 127024581 | 12702458 | 1 | 201606 | 0 |