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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125010223 | 12501022 | 3 | F | 20160403 | 20160630 | 20160627 | 20160706 | EXP | FR-AFSSAPS-NC20160821 | FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-40209FF | BOEHRINGER INGELHEIM | 70.52 | YR | M | Y | 0.00000 | 20160706 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125010223 | 12501022 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | 22512 | 110 | MG | CAPSULE | BID | ||||||
| 125010223 | 12501022 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 125010223 | 12501022 | 3 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125010223 | 12501022 | 1 | Atrial fibrillation |
| 125010223 | 12501022 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125010223 | 12501022 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125010223 | 12501022 | Drug ineffective | |
| 125010223 | 12501022 | Ischaemic stroke |
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 |
|---|---|---|---|---|---|---|
| 125010223 | 12501022 | 1 | 20160403 | 0 |