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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125190011 | 12519001 | 1 | I | 2014 | 20160509 | 20160701 | 20160701 | PER | DE-BFARM-16141549 | DE-LUPIN PHARMACEUTICALS INC.-E2B_00005436 | LUPIN | 66.00 | YR | M | Y | 93.00000 | KG | 20160630 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125190011 | 12519001 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | Y | UNKNOWN | 78103 | |||||||||
| 125190011 | 12519001 | 2 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | Y | UNKNOWN | 78103 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125190011 | 12519001 | 1 | Hyperlipidaemia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125190011 | 12519001 | Gait disturbance | |
| 125190011 | 12519001 | Myalgia |
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 |
|---|---|---|---|---|---|---|
| 125190011 | 12519001 | 1 | 201409 | 201502 | 0 | |
| 125190011 | 12519001 | 2 | 201503 | 201505 | 0 |