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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126206911 | 12620691 | 1 | I | 2016 | 20160726 | 20160804 | 20160804 | EXP | FR-AMGEN-FRASP2016099837 | AMGEN | 88.00 | YR | E | F | Y | 0.00000 | 20160804 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126206911 | 12620691 | 1 | PS | Procoralan | IVABRADINE | 1 | Oral | 5 MG, BID | Y | 206143 | 5 | MG | TABLET | BID | |||||
| 126206911 | 12620691 | 2 | SS | BISOPROLOL FUMARATE. | BISOPROLOL FUMARATE | 1 | Oral | UNK | 0 | ||||||||||
| 126206911 | 12620691 | 3 | SS | LASILIX | FUROSEMIDE | 1 | Oral | 120 MG, QD | 0 | 120 | MG | QD | |||||||
| 126206911 | 12620691 | 4 | C | PREVISCAN | FLUINDIONE | 1 | UNK | 0 | |||||||||||
| 126206911 | 12620691 | 5 | C | CANDESARTAN CILEXETIL. | CANDESARTAN CILEXETIL | 1 | UNK | 0 | |||||||||||
| 126206911 | 12620691 | 6 | C | DISCOTRINE | NITROGLYCERIN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126206911 | 12620691 | 1 | Product used for unknown indication |
| 126206911 | 12620691 | 2 | Atrial fibrillation |
| 126206911 | 12620691 | 3 | Cardiac failure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126206911 | 12620691 | HO |
| 126206911 | 12620691 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126206911 | 12620691 | Acute kidney injury | |
| 126206911 | 12620691 | Bradycardia | |
| 126206911 | 12620691 | Bundle branch block left | |
| 126206911 | 12620691 | Coma | |
| 126206911 | 12620691 | Decreased appetite | |
| 126206911 | 12620691 | Dyspnoea | |
| 126206911 | 12620691 | Gait disturbance | |
| 126206911 | 12620691 | General physical health deterioration | |
| 126206911 | 12620691 | Haemoglobin decreased | |
| 126206911 | 12620691 | Hyponatraemia | |
| 126206911 | 12620691 | International normalised ratio increased | |
| 126206911 | 12620691 | Malaise | |
| 126206911 | 12620691 | Rash | |
| 126206911 | 12620691 | Vomiting | |
| 126206911 | 12620691 | Xerosis |
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 |
|---|---|---|---|---|---|---|
| 126206911 | 12620691 | 1 | 20160420 | 0 | ||
| 126206911 | 12620691 | 2 | 20160420 | 0 | ||
| 126206911 | 12620691 | 3 | 2016 | 20160420 | 0 |