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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125612791 | 12561279 | 1 | I | 201606 | 20160630 | 20160715 | 20160715 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-43307DE | BOEHRINGER INGELHEIM | 83.00 | YR | M | Y | 80.00000 | KG | 20160715 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125612791 | 12561279 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | Y | 22512 | 110 | MG | CAPSULE, HARD | BID | |||||
| 125612791 | 12561279 | 2 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | 100 MG | Y | 0 | 100 | MG | TABLET | QD | |||||
| 125612791 | 12561279 | 3 | SS | ASPIRIN. | ASPIRIN | 1 | Y | 0 | |||||||||||
| 125612791 | 12561279 | 4 | SS | ASPIRIN. | ASPIRIN | 1 | Y | 0 | |||||||||||
| 125612791 | 12561279 | 5 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 125612791 | 12561279 | 6 | C | BISOPROLOL | BISOPROLOL | 1 | 0 | ||||||||||||
| 125612791 | 12561279 | 7 | C | BISOPROLOL | BISOPROLOL | 1 | 0 | ||||||||||||
| 125612791 | 12561279 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125612791 | 12561279 | 1 | Atrial fibrillation |
| 125612791 | 12561279 | 2 | Coronary artery disease |
| 125612791 | 12561279 | 3 | Myocardial infarction |
| 125612791 | 12561279 | 4 | Percutaneous coronary intervention |
| 125612791 | 12561279 | 5 | Coronary artery disease |
| 125612791 | 12561279 | 6 | Myocardial infarction |
| 125612791 | 12561279 | 7 | Percutaneous coronary intervention |
| 125612791 | 12561279 | 8 | Coronary artery disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125612791 | 12561279 | LT |
| 125612791 | 12561279 | HO |
| 125612791 | 12561279 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125612791 | 12561279 | Bladder cancer | |
| 125612791 | 12561279 | Blood urine present | |
| 125612791 | 12561279 | Off label use | |
| 125612791 | 12561279 | Urinary bladder haemorrhage | |
| 125612791 | 12561279 | Urinary tract operation |
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 |
|---|---|---|---|---|---|---|
| 125612791 | 12561279 | 1 | 201602 | 20160626 | 0 | |
| 125612791 | 12561279 | 2 | 2005 | 2016 | 0 | |
| 125612791 | 12561279 | 5 | 2005 | 2006 | 0 | |
| 125612791 | 12561279 | 8 | 2005 | 2016 | 0 |