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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125701993 | 12570199 | 3 | F | 20160627 | 20160803 | 20160719 | 20160805 | EXP | FR-AFSSAPS-MA20161530 | FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-46869FF | BOEHRINGER INGELHEIM | 65.93 | YR | M | Y | 0.00000 | 20160805 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125701993 | 12570199 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | Y | 22512 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125701993 | 12570199 | 1 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125701993 | 12570199 | HO |
| 125701993 | 12570199 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125701993 | 12570199 | Anaemia | |
| 125701993 | 12570199 | Cerebral haematoma | |
| 125701993 | 12570199 | Coma | |
| 125701993 | 12570199 | Fall | |
| 125701993 | 12570199 | Haemothorax | |
| 125701993 | 12570199 | Head injury | |
| 125701993 | 12570199 | Subdural haematoma |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |