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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127232381 | 12723238 | 1 | I | 20121217 | 20160826 | 20160908 | 20160908 | EXP | IT-APOTEX-2016AP011031 | APOTEX | 63.72 | YR | F | Y | 62.00000 | KG | 20160908 | CN | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127232381 | 12723238 | 1 | SS | PRAVASTATINA DOC GENERICI | PRAVASTATIN SODIUM | 1 | Oral | Y | 0 | TABLET | |||||||||
| 127232381 | 12723238 | 2 | SS | SIMVASTATINA DOC GENERICI | SIMVASTATIN | 1 | Oral | Y | 0 | TABLET | |||||||||
| 127232381 | 12723238 | 3 | PS | ATORVASTATINA DOC GENERICI COMPRESSE RIVESTITE CON FILM | ATORVASTATIN | 1 | Oral | Y | 90548 | TABLET | |||||||||
| 127232381 | 12723238 | 4 | SS | ROSUVASTATIN. | ROSUVASTATIN | 1 | Oral | Y | 0 | ||||||||||
| 127232381 | 12723238 | 5 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Unknown | U | U | 0 | |||||||||
| 127232381 | 12723238 | 6 | C | VALSARTAN + HIDROCLOROTIAZIDA | HYDROCHLOROTHIAZIDEVALSARTAN | 1 | Unknown | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127232381 | 12723238 | 1 | Type IIa hyperlipidaemia |
| 127232381 | 12723238 | 2 | Type IIa hyperlipidaemia |
| 127232381 | 12723238 | 3 | Type IIa hyperlipidaemia |
| 127232381 | 12723238 | 4 | Type IIa hyperlipidaemia |
| 127232381 | 12723238 | 5 | Hypertension |
| 127232381 | 12723238 | 6 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127232381 | 12723238 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127232381 | 12723238 | Asthenia | |
| 127232381 | 12723238 | Myopathy | |
| 127232381 | 12723238 | Pain in extremity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |