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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123837265 | 12383726 | 5 | F | 20160507 | 20160623 | 20160519 | 20160705 | EXP | PHEH2016US012072 | NOVARTIS | 56.83 | YR | M | Y | 120.18000 | KG | 20160705 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123837265 | 12383726 | 1 | PS | ENTRESTO | SACUBITRILVALSARTAN | 1 | Oral | 50 MG, BID | 2320 | MG | 207620 | 50 | MG | TABLET | BID | ||||
| 123837265 | 12383726 | 2 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | Y | 0 | ||||||||||
| 123837265 | 12383726 | 3 | SS | LOVASTATIN TABLETS USP | LOVASTATIN | 1 | Oral | 40 MG, QD | 4160 | MG | Y | 0 | 40 | MG | TABLET | QD | |||
| 123837265 | 12383726 | 4 | C | MECLIZINE | MECLIZINE HYDROCHLORIDE | 1 | Unknown | 12.5 MG, QD | U | 0 | 12.5 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123837265 | 12383726 | 1 | Cardiac failure chronic |
| 123837265 | 12383726 | 2 | Product used for unknown indication |
| 123837265 | 12383726 | 3 | Dyslipidaemia |
| 123837265 | 12383726 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123837265 | 12383726 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123837265 | 12383726 | Blood creatine phosphokinase increased | |
| 123837265 | 12383726 | Hepatic enzyme increased |
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 |
|---|---|---|---|---|---|---|
| 123837265 | 12383726 | 1 | 20160414 | 20160513 | 0 | |
| 123837265 | 12383726 | 3 | 20160125 | 20160513 | 0 |