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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124971796 | 12497179 | 6 | F | 20160510 | 20160920 | 20160624 | 20160923 | EXP | JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-40572NB | BOEHRINGER INGELHEIM | 66.12 | YR | M | Y | 0.00000 | 20160923 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124971796 | 12497179 | 1 | PS | PRAZAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 124971796 | 12497179 | 2 | SS | DIOVAN | VALSARTAN | 1 | Unknown | 20 MG | Y | 0 | 20 | MG | TABLET | QD | |||||
| 124971796 | 12497179 | 3 | SS | SELARA | EPLERENONE | 1 | Unknown | 50 MG | Y | 0 | 25 | MG | TABLET | BID | |||||
| 124971796 | 12497179 | 4 | C | MAINTATE | BISOPROLOL FUMARATE | 1 | Unknown | 5 MG | Y | 0 | 5 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124971796 | 12497179 | 1 | Atrial fibrillation |
| 124971796 | 12497179 | 2 | Cardiac failure chronic |
| 124971796 | 12497179 | 3 | Cardiac failure chronic |
| 124971796 | 12497179 | 4 | Cardiac failure chronic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124971796 | 12497179 | HO |
| 124971796 | 12497179 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124971796 | 12497179 | Acute kidney injury | |
| 124971796 | 12497179 | Anaemia | |
| 124971796 | 12497179 | Coagulopathy | |
| 124971796 | 12497179 | Contusion | |
| 124971796 | 12497179 | Dehydration | |
| 124971796 | 12497179 | Fall | |
| 124971796 | 12497179 | Haematuria | |
| 124971796 | 12497179 | Hyperkalaemia | |
| 124971796 | 12497179 | Lower gastrointestinal haemorrhage | |
| 124971796 | 12497179 | Metabolic acidosis | |
| 124971796 | 12497179 | Purpura | |
| 124971796 | 12497179 | Subarachnoid haemorrhage | |
| 124971796 | 12497179 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 124971796 | 12497179 | 1 | 20160517 | 0 | ||
| 124971796 | 12497179 | 2 | 20160517 | 0 | ||
| 124971796 | 12497179 | 3 | 20160517 | 0 | ||
| 124971796 | 12497179 | 4 | 20160517 | 0 |