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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110690637 | 11069063 | 7 | F | 20141105 | 20160920 | 20150427 | 20160923 | EXP | GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2015-BI-21264BI | BOEHRINGER INGELHEIM | 71.66 | YR | M | Y | 83.00000 | KG | 20160923 | MD | COUNTRY NOT SPECIFIED | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110690637 | 11069063 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 300 | MG | TABLET | QD | |||||
| 110690637 | 11069063 | 2 | C | RAMIPRIL. | RAMIPRIL | 1 | Oral | 2.5 MG | 0 | 2.5 | MG | TABLET | QD | ||||||
| 110690637 | 11069063 | 3 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 160 MG | 0 | 160 | MG | TABLET | QD | ||||||
| 110690637 | 11069063 | 4 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 2.5 MG | 0 | 2.5 | MG | TABLET | QD | ||||||
| 110690637 | 11069063 | 5 | C | AMIODARONE | AMIODARONE | 1 | Oral | 600 MG | 0 | 600 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110690637 | 11069063 | 1 | Atrial fibrillation |
| 110690637 | 11069063 | 2 | Cardiac failure |
| 110690637 | 11069063 | 3 | Cardiac failure |
| 110690637 | 11069063 | 4 | Cardiac failure |
| 110690637 | 11069063 | 5 | Cardiac failure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110690637 | 11069063 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110690637 | 11069063 | Cardiac failure | |
| 110690637 | 11069063 | Dyspnoea | |
| 110690637 | 11069063 | Glomerular filtration rate decreased | |
| 110690637 | 11069063 | Left ventricular failure | |
| 110690637 | 11069063 | Malaise | |
| 110690637 | 11069063 | Therapy cessation | |
| 110690637 | 11069063 | Therapy change |
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 |
|---|---|---|---|---|---|---|
| 110690637 | 11069063 | 1 | 20141101 | 0 | ||
| 110690637 | 11069063 | 2 | 20141103 | 0 | ||
| 110690637 | 11069063 | 3 | 20141031 | 20141110 | 0 | |
| 110690637 | 11069063 | 4 | 20141031 | 0 | ||
| 110690637 | 11069063 | 5 | 20141031 | 0 |