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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124814314 | 12481431 | 4 | F | 20160518 | 20160801 | 20160620 | 20160811 | EXP | ES-TAKEDA-2016TUS010367 | TAKEDA | 67.00 | YR | F | Y | 0.00000 | 20160811 | MD | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124814314 | 12481431 | 1 | PS | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Unknown | 20 MG, QD | Y | 204447 | 20 | MG | TABLET | QD | |||||
| 124814314 | 12481431 | 2 | SS | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Unknown | 10 MG, QD | Y | 204447 | 10 | MG | TABLET | QD | |||||
| 124814314 | 12481431 | 3 | SS | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Unknown | 240 MG, UNK | Y | 204447 | 240 | MG | TABLET | ||||||
| 124814314 | 12481431 | 4 | SS | BRINTELLIX | VORTIOXETINE HYDROBROMIDE | 1 | Unknown | 10 MG, QD | Y | 204447 | 10 | MG | TABLET | QD | |||||
| 124814314 | 12481431 | 5 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 5 MG, QD | U | 0 | 5 | MG | QD | ||||||
| 124814314 | 12481431 | 6 | SS | OLANZAPINE. | OLANZAPINE | 1 | Unknown | 70 MG, UNK | U | 0 | 70 | MG | |||||||
| 124814314 | 12481431 | 7 | SS | LITHIUM. | LITHIUM | 1 | Unknown | 8 G, UNK | U | 0 | 8 | G | |||||||
| 124814314 | 12481431 | 8 | C | ALPRAZOLAM. | ALPRAZOLAM | 1 | Unknown | 0.5 MG, Q8HR | U | 0 | .5 | MG | Q8H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124814314 | 12481431 | 1 | Depression |
| 124814314 | 12481431 | 5 | Borderline mental impairment |
| 124814314 | 12481431 | 7 | Product used for unknown indication |
| 124814314 | 12481431 | 8 | Borderline mental impairment |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124814314 | 12481431 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124814314 | 12481431 | Coordination abnormal | |
| 124814314 | 12481431 | Dysarthria | |
| 124814314 | 12481431 | Gait disturbance | |
| 124814314 | 12481431 | Intentional overdose | |
| 124814314 | 12481431 | Sedation | |
| 124814314 | 12481431 | Sluggishness | |
| 124814314 | 12481431 | 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 |
|---|---|---|---|---|---|---|
| 124814314 | 12481431 | 1 | 20160505 | 201605 | 0 | |
| 124814314 | 12481431 | 2 | 201605 | 201605 | 0 | |
| 124814314 | 12481431 | 3 | 20160518 | 0 | ||
| 124814314 | 12481431 | 5 | 20160509 | 0 | ||
| 124814314 | 12481431 | 6 | 20160518 | 0 | ||
| 124814314 | 12481431 | 7 | 20160518 | 0 | ||
| 124814314 | 12481431 | 8 | 2011 | 0 |