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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125395601 | 12539560 | 1 | I | 20160619 | 20160624 | 20160708 | 20160708 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41230BP | BOEHRINGER INGELHEIM | 77.90 | YR | F | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125395601 | 12539560 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 75 MG | Y | 501933 | 22512 | 150 | MG | CAPSULE | QOD | ||||
| 125395601 | 12539560 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 75 MG | Y | 501933 | 22512 | 150 | MG | CAPSULE | QOD | ||||
| 125395601 | 12539560 | 3 | C | DILTIAZEM. | DILTIAZEM | 1 | Oral | 0 | TABLET | QD | |||||||||
| 125395601 | 12539560 | 4 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125395601 | 12539560 | 1 | Atrial fibrillation |
| 125395601 | 12539560 | 3 | Atrial fibrillation |
| 125395601 | 12539560 | 4 | Atrial fibrillation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125395601 | 12539560 | Eye contusion | |
| 125395601 | 12539560 | Eye swelling | |
| 125395601 | 12539560 | Face injury | |
| 125395601 | 12539560 | Fall | |
| 125395601 | 12539560 | Gait disturbance | |
| 125395601 | 12539560 | Head injury |
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 |
|---|---|---|---|---|---|---|
| 125395601 | 12539560 | 1 | 2014 | 20160620 | 0 | |
| 125395601 | 12539560 | 2 | 20160624 | 0 | ||
| 125395601 | 12539560 | 3 | 2006 | 0 | ||
| 125395601 | 12539560 | 4 | 2006 | 0 |