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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125818092 | 12581809 | 2 | F | 20160404 | 20160718 | 20160722 | 20160725 | EXP | IT-009507513-1607ITA008429 | MERCK | 25.00 | YR | F | Y | 0.00000 | 20160725 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125818092 | 12581809 | 1 | PS | MIRTAZAPINE. | MIRTAZAPINE | 1 | Oral | TOTAL: 20 DOSE UNIT | Y | U | 20415 | 20 | DF | TABLET | 1X | ||||
| 125818092 | 12581809 | 2 | SS | SAMYR | ADEMETIONINE | 1 | Oral | 400 MG, TOTAL: 1 DOSE UNIT | Y | U | 0 | 400 | MG | TABLET | 1X | ||||
| 125818092 | 12581809 | 3 | SS | ZOLPIDEM | ZOLPIDEMOLPIDEM TARTRATE | 1 | Oral | TOTAL: 20 DOSE UNITS | Y | U | 0 | 20 | DF | 1X | |||||
| 125818092 | 12581809 | 4 | SS | SERTRALINE HYDROCHLORIDE. | SERTRALINE HYDROCHLORIDE | 1 | Oral | TOTAL: 25 DOSE UNITS | Y | U | 0 | 25 | DF | 1X | |||||
| 125818092 | 12581809 | 5 | SS | ESCITALOPRAM | ESCITALOPRAM OXALATE | 1 | Oral | TOTAL: 10 DROPS, FORMULATION: DROPS | Y | U | 0 | 10 | DF | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125818092 | 12581809 | 1 | Depression |
| 125818092 | 12581809 | 2 | Depression |
| 125818092 | 12581809 | 3 | Depression |
| 125818092 | 12581809 | 4 | Depression |
| 125818092 | 12581809 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125818092 | 12581809 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125818092 | 12581809 | Drug abuse | |
| 125818092 | 12581809 | 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 |
|---|---|---|---|---|---|---|
| 125818092 | 12581809 | 1 | 20160404 | 20160404 | 0 | |
| 125818092 | 12581809 | 2 | 20160404 | 20160404 | 0 | |
| 125818092 | 12581809 | 3 | 20160404 | 20160404 | 0 | |
| 125818092 | 12581809 | 4 | 20160404 | 20160404 | 0 | |
| 125818092 | 12581809 | 5 | 20160404 | 20160404 | 0 |