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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125764991 | 12576499 | 1 | I | 20160621 | 20160711 | 20160720 | 20160720 | EXP | DE-MYLANLABS-2016M1029280 | MYLAN | 0.00 | Y | 0.00000 | 20160720 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125764991 | 12576499 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 80 MG, QD (DAILY DOSE: 80 MG MILLGRAM(S) EVERY DAYS) | U | U | 90868 | 80 | MG | QD | |||||
| 125764991 | 12576499 | 2 | SS | ADENURIC | FEBUXOSTAT | 1 | 80 MG, QD (DAILY DOSE: 80 MG MILLGRAM(S) EVERY DAYS) | U | U | 0 | 80 | MG | QD | ||||||
| 125764991 | 12576499 | 3 | C | VALSACOR | VALSARTAN | 1 | Oral | 1 DF, QD (DAILY DOSE: 1 DF DOSAGE FORM EVERY DAYS) | U | 0 | 1 | DF | QD | ||||||
| 125764991 | 12576499 | 4 | C | RANEXA | RANOLAZINE | 1 | Oral | 375 DF, BID (DAILY DOSE: 750 DF DOSAGE FORM EVERY DAYS) | U | 0 | 375 | DF | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125764991 | 12576499 | 1 | Hyperlipidaemia |
| 125764991 | 12576499 | 2 | Hyperuricaemia |
| 125764991 | 12576499 | 3 | Hypertension |
| 125764991 | 12576499 | 4 | Arrhythmia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125764991 | 12576499 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125764991 | 12576499 | Hypoaesthesia | |
| 125764991 | 12576499 | Myopathy | |
| 125764991 | 12576499 | Renal failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |