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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123107205 | 12310720 | 5 | F | 20160401 | 20160704 | 20160427 | 20160712 | EXP | PHHO2016CA004963 | SANDOZ | 73.27 | YR | M | Y | 76.00000 | KG | 20160713 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123107205 | 12310720 | 1 | PS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, QD | 160 | MG | 18569 | 40 | MG | QD | |||||
| 123107205 | 12310720 | 2 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 MG, BID | 160 | MG | 18569 | 40 | MG | BID | |||||
| 123107205 | 12310720 | 3 | SS | METFORMINE HCL | METFORMIN HYDROCHLORIDE | 1 | Oral | Y | 0 | ||||||||||
| 123107205 | 12310720 | 4 | SS | METFORMINE HCL | METFORMIN HYDROCHLORIDE | 1 | Oral | 500 MG, BID | Y | 0 | 500 | MG | BID | ||||||
| 123107205 | 12310720 | 5 | SS | DIOVAN | VALSARTAN | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 123107205 | 12310720 | 6 | SS | BLINDED LCZ696 | SACUBITRIL | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 123107205 | 12310720 | 7 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 123107205 | 12310720 | 8 | SS | DIOVAN | VALSARTAN | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 123107205 | 12310720 | 9 | SS | BLINDED LCZ696 | SACUBITRIL | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 123107205 | 12310720 | 10 | SS | BLINDED NO TREATMENT RECEIVED | INVESTIGATIONAL PRODUCT | 1 | Oral | CODE NOT BROKEN | 0 | TABLET | |||||||||
| 123107205 | 12310720 | 11 | SS | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 12.5 MG, QD | 800 | MG | 0 | 12.5 | MG | QD | |||||
| 123107205 | 12310720 | 12 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 10 MG, BID | Y | 0 | 10 | MG | BID | ||||||
| 123107205 | 12310720 | 13 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | UNK | Y | 0 | BID | ||||||||
| 123107205 | 12310720 | 14 | C | COUMADIN | WARFARIN SODIUM | 1 | Unknown | 0 | |||||||||||
| 123107205 | 12310720 | 15 | C | AMIODARONE | AMIODARONE | 1 | Oral | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 123107205 | 12310720 | 16 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 123107205 | 12310720 | 17 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 7.5 MG, UNK | 0 | 7.5 | MG | ||||||||
| 123107205 | 12310720 | 18 | C | BISOPROLOL | BISOPROLOL | 1 | Oral | 10 MG, BID | 0 | 10 | MG | BID | |||||||
| 123107205 | 12310720 | 19 | C | WARFARIN | WARFARIN | 1 | Unknown | 0 | |||||||||||
| 123107205 | 12310720 | 20 | C | ROSUVASTATINE | ROSUVASTATIN | 1 | Oral | 10 MG, BID | 0 | 10 | MG | BID | |||||||
| 123107205 | 12310720 | 21 | C | ROSUVASTATINE | ROSUVASTATIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123107205 | 12310720 | 1 | Cardiac failure chronic |
| 123107205 | 12310720 | 3 | Product used for unknown indication |
| 123107205 | 12310720 | 5 | Cardiac failure chronic |
| 123107205 | 12310720 | 6 | Cardiac failure chronic |
| 123107205 | 12310720 | 7 | Cardiac failure chronic |
| 123107205 | 12310720 | 11 | Cardiac failure chronic |
| 123107205 | 12310720 | 12 | Cardiac failure chronic |
| 123107205 | 12310720 | 13 | Hypertension |
| 123107205 | 12310720 | 14 | Product used for unknown indication |
| 123107205 | 12310720 | 15 | Atrial fibrillation |
| 123107205 | 12310720 | 16 | Cardiac failure chronic |
| 123107205 | 12310720 | 17 | Hypertension |
| 123107205 | 12310720 | 19 | Atrial fibrillation |
| 123107205 | 12310720 | 20 | Hyperlipidaemia |
| 123107205 | 12310720 | 21 | Coronary artery disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123107205 | 12310720 | OT |
| 123107205 | 12310720 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123107205 | 12310720 | Acute kidney injury | |
| 123107205 | 12310720 | Acute myocardial infarction | |
| 123107205 | 12310720 | Anaemia | |
| 123107205 | 12310720 | Cardiac failure chronic | |
| 123107205 | 12310720 | Gastric polyps | |
| 123107205 | 12310720 | Haemorrhage | |
| 123107205 | 12310720 | Large intestine polyp |
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 |
|---|---|---|---|---|---|---|
| 123107205 | 12310720 | 1 | 20150529 | 0 | ||
| 123107205 | 12310720 | 2 | 20160331 | 20160401 | 0 | |
| 123107205 | 12310720 | 4 | 20160423 | 0 | ||
| 123107205 | 12310720 | 5 | 20150520 | 20160401 | 0 | |
| 123107205 | 12310720 | 6 | 20150520 | 20160401 | 0 | |
| 123107205 | 12310720 | 7 | 20150520 | 20160401 | 0 | |
| 123107205 | 12310720 | 8 | 20160502 | 0 | ||
| 123107205 | 12310720 | 9 | 20160502 | 0 | ||
| 123107205 | 12310720 | 10 | 20160502 | 0 | ||
| 123107205 | 12310720 | 11 | 20160129 | 20160401 | 0 | |
| 123107205 | 12310720 | 12 | 2011 | 20160401 | 0 | |
| 123107205 | 12310720 | 13 | 20160402 | 0 | ||
| 123107205 | 12310720 | 15 | 201309 | 0 | ||
| 123107205 | 12310720 | 16 | 20160129 | 20160401 | 0 | |
| 123107205 | 12310720 | 17 | 20160408 | 0 | ||
| 123107205 | 12310720 | 19 | 200507 | 0 | ||
| 123107205 | 12310720 | 20 | 20160406 | 0 |