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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126856561 | 12685656 | 1 | I | 20160507 | 20160812 | 20160825 | 20160825 | EXP | IT-MINISAL02-371144 | IT-TEVA-686445ACC | TEVA | 20.18 | YR | F | Y | 0.00000 | 20160825 | PH | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126856561 | 12685656 | 1 | PS | SERTRALINE HYDROCHLORIDE. | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MILLIGRAM DAILY; | Y | 77663 | 50 | MG | |||||||
| 126856561 | 12685656 | 2 | SS | HALDOL | HALOPERIDOL | 1 | Oral | 2 MILLIGRAM DAILY; | Y | 0 | 2 | MG | |||||||
| 126856561 | 12685656 | 3 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | U | 0 | 10 | GTT |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126856561 | 12685656 | 1 | Psychotic disorder |
| 126856561 | 12685656 | 2 | Psychotic disorder |
| 126856561 | 12685656 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126856561 | 12685656 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126856561 | 12685656 | Confusional state | |
| 126856561 | 12685656 | Extrapyramidal disorder | |
| 126856561 | 12685656 | Joint stiffness | |
| 126856561 | 12685656 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 126856561 | 12685656 | 1 | 20160506 | 20160510 | 0 | |
| 126856561 | 12685656 | 2 | 20160506 | 20160510 | 0 |