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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377302 | 12537730 | 2 | F | 20160526 | 20160713 | 20160707 | 20160727 | EXP | 364577 | IT-VALIDUS PHARMACEUTICALS LLC-IT-2016VAL002231 | VALIDUS | 86.00 | YR | F | Y | 0.00000 | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125377302 | 12537730 | 1 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 25 MG, DAILY | 16273 | 25 | MG | TABLET | |||||||
| 125377302 | 12537730 | 2 | SS | AMIODARONE | AMIODARONE | 1 | Intravenous (not otherwise specified) | UNK | Y | 0 | |||||||||
| 125377302 | 12537730 | 3 | SS | OLANZAPINE. | OLANZAPINE | 1 | Oral | 5 MG, DAILY | 0 | 5 | MG | ||||||||
| 125377302 | 12537730 | 4 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 75 MG, DAILY | 0 | 75 | MG | TABLET | |||||||
| 125377302 | 12537730 | 5 | C | ALDACTONE | SPIRONOLACTONE | 1 | UNK | U | 0 | ||||||||||
| 125377302 | 12537730 | 6 | C | BISOPROLOL FUMARATE. | BISOPROLOL FUMARATE | 1 | UNK | U | 0 | ||||||||||
| 125377302 | 12537730 | 7 | C | COUMADIN | WARFARIN SODIUM | 1 | UNK | U | 0 | ||||||||||
| 125377302 | 12537730 | 8 | C | HALCION | TRIAZOLAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125377302 | 12537730 | 1 | Product used for unknown indication |
| 125377302 | 12537730 | 2 | Atrial fibrillation |
| 125377302 | 12537730 | 3 | Product used for unknown indication |
| 125377302 | 12537730 | 4 | Product used for unknown indication |
| 125377302 | 12537730 | 5 | Product used for unknown indication |
| 125377302 | 12537730 | 6 | Product used for unknown indication |
| 125377302 | 12537730 | 7 | Product used for unknown indication |
| 125377302 | 12537730 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125377302 | 12537730 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125377302 | 12537730 | Drug interaction | |
| 125377302 | 12537730 | Electrocardiogram QT prolonged | |
| 125377302 | 12537730 | Extrasystoles | |
| 125377302 | 12537730 | Torsade de pointes |
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 |
|---|---|---|---|---|---|---|
| 125377302 | 12537730 | 2 | 20160526 | 20160526 | 0 |