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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124336432 | 12433643 | 2 | F | 2015 | 20160627 | 20160603 | 20160708 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-32417BP | BOEHRINGER INGELHEIM | 0.00 | F | Y | 77.11000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124336432 | 12433643 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | DOSE:150MG | Y | 22512 | CAPSULE | ||||||||
| 124336432 | 12433643 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | Y | 22512 | CAPSULE | |||||||||
| 124336432 | 12433643 | 3 | C | VALSARTAN. | VALSARTAN | 1 | Oral | 150 MG | 0 | 150 | MG | TABLET | QD | ||||||
| 124336432 | 12433643 | 4 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 125 MG | 0 | 125 | MG | TABLET | QD | ||||||
| 124336432 | 12433643 | 5 | C | DILTIAZEM. | DILTIAZEM | 1 | Oral | 1 ANZ | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124336432 | 12433643 | 1 | Atrial fibrillation |
| 124336432 | 12433643 | 3 | Cardiac disorder |
| 124336432 | 12433643 | 4 | Cardiac disorder |
| 124336432 | 12433643 | 5 | Cardiac disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124336432 | 12433643 | Off label use | |
| 124336432 | 12433643 | Renal impairment | |
| 124336432 | 12433643 | Skin papilloma |
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 |
|---|---|---|---|---|---|---|
| 124336432 | 12433643 | 1 | 201207 | 201403 | 0 | |
| 124336432 | 12433643 | 2 | 2015 | 0 |