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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119226623 | 11922662 | 3 | F | 20140503 | 20160921 | 20160115 | 20160928 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-01643BI | BOEHRINGER INGELHEIM | 78.63 | YR | M | Y | 0.00000 | 20160928 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119226623 | 11922662 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | Q12H | |||||
| 119226623 | 11922662 | 2 | C | AMIODARONE | AMIODARONE | 1 | Oral | 200 MG | 0 | 200 | MG | TABLET | QD | ||||||
| 119226623 | 11922662 | 3 | C | DILTIAZEM. | DILTIAZEM | 1 | Oral | 240 MG | 0 | 120 | MG | CAPSULE | BID | ||||||
| 119226623 | 11922662 | 4 | C | METANX | LEVOMEFOLATE CALCIUMMETHYLCOBALAMINPYRIDOXAL PHOSPHATE ANHYDROUS | 1 | Oral | DOSE PER APPLICATION: 3 MG-35 MG--2 MG; DAILY DOSE: 6 MG- 70 MG- 4 MG | 0 | TABLET | BID | ||||||||
| 119226623 | 11922662 | 5 | C | PYRIDOXINE | PYRIDOXINE | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 119226623 | 11922662 | 6 | C | ECOTRIN | ASPIRIN | 1 | Oral | 0.5 ANZ | 0 | TABLET | QD | ||||||||
| 119226623 | 11922662 | 7 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119226623 | 11922662 | 1 | Atrial fibrillation |
| 119226623 | 11922662 | 2 | Product used for unknown indication |
| 119226623 | 11922662 | 3 | Product used for unknown indication |
| 119226623 | 11922662 | 4 | Product used for unknown indication |
| 119226623 | 11922662 | 5 | Product used for unknown indication |
| 119226623 | 11922662 | 6 | Product used for unknown indication |
| 119226623 | 11922662 | 7 | Urine output decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119226623 | 11922662 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119226623 | 11922662 | Anaemia | |
| 119226623 | 11922662 | Gastrointestinal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 119226623 | 11922662 | 1 | 20101122 | 0 |