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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102343685 | 10234368 | 5 | F | 2008 | 20160623 | 20140612 | 20160701 | EXP | NO-009507513-1406NOR000845 | MERCK | 81.00 | YR | F | Y | 0.00000 | 20160701 | OT | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 102343685 | 10234368 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | 80 MG, QD | Y | U | 19766 | 80 | MG | TABLET | QD | |||||
| 102343685 | 10234368 | 2 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Y | U | 19766 | TABLET | |||||||||
| 102343685 | 10234368 | 3 | SS | ATORVASTATIN | ATORVASTATIN | 1 | 80 MG, QD | Y | U | 0 | 80 | MG | QD | ||||||
| 102343685 | 10234368 | 4 | SS | ATORVASTATIN | ATORVASTATIN | 1 | 40 MG, QD | Y | U | 0 | 40 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 102343685 | 10234368 | 1 | Hypertension |
| 102343685 | 10234368 | 2 | Hypercholesterolaemia |
| 102343685 | 10234368 | 3 | Hypercholesterolaemia |
| 102343685 | 10234368 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 102343685 | 10234368 | HO |
| 102343685 | 10234368 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 102343685 | 10234368 | Asthenia | |
| 102343685 | 10234368 | Blood creatine phosphokinase increased | |
| 102343685 | 10234368 | Fatigue | |
| 102343685 | 10234368 | Gait disturbance | |
| 102343685 | 10234368 | Immune-mediated necrotising myopathy | |
| 102343685 | 10234368 | Muscular weakness |
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 |
|---|---|---|---|---|---|---|
| 102343685 | 10234368 | 3 | 2007 | 0 |