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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127885851 | 12788585 | 1 | I | 20160711 | 20160916 | 20160928 | 20160928 | EXP | IT-MINISAL02-374743 | IT-TEVA-695729ACC | TEVA | 63.00 | YR | M | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127885851 | 12788585 | 1 | PS | ZOLPIDEM TARTRATE. | ZOLPIDEM TARTRATE | 1 | Oral | 10 MG AS NECESSARY | Y | 75479 | 10 | MG | |||||||
| 127885851 | 12788585 | 2 | C | AKINETON | BIPERIDEN HYDROCHLORIDE | 1 | Oral | 1 DF | U | 0 | 1 | DF | |||||||
| 127885851 | 12788585 | 3 | C | RISPERIDONE. | RISPERIDONE | 1 | Oral | 1 MG | U | 0 | 1 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127885851 | 12788585 | 1 | Insomnia |
| 127885851 | 12788585 | 2 | Psychotic disorder |
| 127885851 | 12788585 | 3 | Psychotic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127885851 | 12788585 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127885851 | 12788585 | Drug abuse | |
| 127885851 | 12788585 | Sopor |
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 |
|---|---|---|---|---|---|---|
| 127885851 | 12788585 | 1 | 20120828 | 20160711 | 0 |