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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124044553 | 12404455 | 3 | F | 20160511 | 20160922 | 20160525 | 20160926 | EXP | SI-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-33139SL | BOEHRINGER INGELHEIM | 83.74 | YR | F | Y | 0.00000 | 20160926 | MD | SI | SI |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124044553 | 12404455 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | U | 22512 | 110 | MG | CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124044553 | 12404455 | 1 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124044553 | 12404455 | DE |
| 124044553 | 12404455 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124044553 | 12404455 | Cerebral haematoma | |
| 124044553 | 12404455 | Fall |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |