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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126517561 | 12651756 | 1 | I | 201607 | 20160801 | 20160815 | 20160815 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-50430BP | BOEHRINGER INGELHEIM | 66.26 | YR | M | Y | 0.00000 | 20160815 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126517561 | 12651756 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 2 ANZ | 507826 | 22512 | CAPSULE | BID | |||||||
| 126517561 | 12651756 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | 507826 | 22512 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126517561 | 12651756 | 1 | Cerebrovascular accident prophylaxis |
| 126517561 | 12651756 | 2 | Atrial fibrillation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126517561 | 12651756 | Abdominal discomfort | |
| 126517561 | 12651756 | Product quality issue | |
| 126517561 | 12651756 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 126517561 | 12651756 | 1 | 201607 | 0 |