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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124488304 | 12448830 | 4 | F | 20160510 | 20160816 | 20160608 | 20160826 | EXP | PHEH2016US013587 | SANDOZ | 79.19 | YR | M | Y | 69.50000 | KG | 20160826 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124488304 | 12448830 | 1 | SS | ENTRESTO | SACUBITRILVALSARTAN | 1 | Oral | 50 MG, BID | Y | 0 | 50 | MG | TABLET | BID | |||||
| 124488304 | 12448830 | 2 | SS | ENTRESTO | SACUBITRILVALSARTAN | 1 | Oral | 50 MG, QD | Y | 0 | 50 | MG | TABLET | QD | |||||
| 124488304 | 12448830 | 3 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 40 OT, QD | U | 0 | QD | ||||||||
| 124488304 | 12448830 | 4 | PS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 50 OT, QD | Y | 86809 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124488304 | 12448830 | 1 | Ejection fraction decreased |
| 124488304 | 12448830 | 2 | Chronic obstructive pulmonary disease |
| 124488304 | 12448830 | 3 | Ejection fraction decreased |
| 124488304 | 12448830 | 4 | Ejection fraction decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124488304 | 12448830 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124488304 | 12448830 | Abdominal pain upper | |
| 124488304 | 12448830 | Bone pain | |
| 124488304 | 12448830 | Decreased appetite | |
| 124488304 | 12448830 | Diarrhoea haemorrhagic | |
| 124488304 | 12448830 | Dizziness | |
| 124488304 | 12448830 | Fatigue | |
| 124488304 | 12448830 | Headache | |
| 124488304 | 12448830 | Hypoacusis | |
| 124488304 | 12448830 | Nausea | |
| 124488304 | 12448830 | Ocular discomfort | |
| 124488304 | 12448830 | Prescribed underdose |
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 |
|---|---|---|---|---|---|---|
| 124488304 | 12448830 | 1 | 20160506 | 0 | ||
| 124488304 | 12448830 | 3 | 20160414 | 0 | ||
| 124488304 | 12448830 | 4 | 20160414 | 20160620 | 0 |