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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125422391 | 12542239 | 1 | I | 20160428 | 20160706 | 20160708 | 20160708 | EXP | RO-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-44700RN | BOEHRINGER INGELHEIM | 76.18 | YR | M | Y | 85.00000 | KG | 20160709 | MD | COUNTRY NOT SPECIFIED | RO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125422391 | 12542239 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 125422391 | 12542239 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | 22512 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125422391 | 12542239 | 1 | Cerebrovascular accident prophylaxis |
| 125422391 | 12542239 | 2 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125422391 | 12542239 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125422391 | 12542239 | Anaemia | |
| 125422391 | 12542239 | Melaena |
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 |
|---|---|---|---|---|---|---|
| 125422391 | 12542239 | 1 | 20160406 | 20160428 | 0 |