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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127100072 | 12710007 | 2 | F | 2013 | 20160916 | 20160902 | 20160921 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-52486BP | BOEHRINGER INGELHEIM | 85.64 | YR | F | Y | 0.00000 | 20160922 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127100072 | 12710007 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG | 22512 | 75 | MG | CAPSULE | BID | ||||||
| 127100072 | 12710007 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | 22512 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127100072 | 12710007 | 1 | Anticoagulant therapy |
| 127100072 | 12710007 | 2 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127100072 | 12710007 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127100072 | 12710007 | Atrial fibrillation | |
| 127100072 | 12710007 | Cardiac failure congestive | |
| 127100072 | 12710007 | Dyspepsia | |
| 127100072 | 12710007 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127100072 | 12710007 | 1 | 2012 | 201608 | 0 |