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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115461862 | 11546186 | 2 | F | 201507 | 20160701 | 20150924 | 20160705 | EXP | FR-JNJFOC-20150910460 | JANSSEN | 23.00 | YR | A | M | Y | 0.00000 | 20160705 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115461862 | 11546186 | 1 | PS | HALDOL | HALOPERIDOL | 1 | Oral | N | 15923 | 15 | MG | UNSPECIFIED | |||||||
| 115461862 | 11546186 | 2 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 0 | 250 | MG | TABLET | BID | |||||||
| 115461862 | 11546186 | 3 | C | LEPTICUR | TROPATEPINE HYDROCHLORIDE | 1 | Oral | 0 | 10 | MG | TABLET | QD | |||||||
| 115461862 | 11546186 | 4 | C | LOXAPAC | LOXAPINE SUCCINATE | 1 | Oral | 0 | 50 | MG | TABLET | TID | |||||||
| 115461862 | 11546186 | 5 | C | VALIUM | DIAZEPAM | 1 | Oral | 0 | 10 | MG | TABLET | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115461862 | 11546186 | 1 | Schizophrenia |
| 115461862 | 11546186 | 2 | Post-traumatic epilepsy |
| 115461862 | 11546186 | 3 | Product used for unknown indication |
| 115461862 | 11546186 | 4 | Product used for unknown indication |
| 115461862 | 11546186 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115461862 | 11546186 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115461862 | 11546186 | Abnormal behaviour | |
| 115461862 | 11546186 | Aggression | |
| 115461862 | 11546186 | Insomnia | |
| 115461862 | 11546186 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 115461862 | 11546186 | 1 | 201505 | 20150724 | 0 |