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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127190631 | 12719063 | 1 | I | 20160830 | 20160907 | 20160907 | EXP | DE-AUROBINDO-AUR-APL-2016-11190 | AUROBINDO | 0.00 | M | Y | 103.00000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127190631 | 12719063 | 1 | SS | Atorvastatin | ATORVASTATIN | 1 | Oral | 1 DF, ONCE A DAY | Y | U | 0 | 1 | DF | QD | |||||
| 127190631 | 12719063 | 2 | SS | PRAVASTATIN. | PRAVASTATIN | 1 | 1 DF, ONCE A DAY | Y | U | 0 | 1 | DF | QD | ||||||
| 127190631 | 12719063 | 3 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | Y | U | 77691 | |||||||||
| 127190631 | 12719063 | 4 | SS | FENOFIBRAT | FENOFIBRATE | 1 | Oral | 1 DF, ONCE A DAY | Y | U | 0 | 1 | DF | QD | |||||
| 127190631 | 12719063 | 5 | C | OMEGA-3 /01866101/ | OMEGA-3 FATTY ACIDS | 1 | 1000 MG, 3 TIMES EVERY 2 DAYS | U | 0 | 1000 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127190631 | 12719063 | 1 | Hypercholesterolaemia |
| 127190631 | 12719063 | 2 | Hypercholesterolaemia |
| 127190631 | 12719063 | 3 | Hypercholesterolaemia |
| 127190631 | 12719063 | 4 | Hypercholesterolaemia |
| 127190631 | 12719063 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127190631 | 12719063 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127190631 | 12719063 | Arthralgia | |
| 127190631 | 12719063 | Gout | |
| 127190631 | 12719063 | Petechiae | |
| 127190631 | 12719063 | Skin exfoliation | |
| 127190631 | 12719063 | Tendon injury |
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 |
|---|---|---|---|---|---|---|
| 127190631 | 12719063 | 1 | 20160218 | 20160223 | 0 | |
| 127190631 | 12719063 | 2 | 20160223 | 20160406 | 0 | |
| 127190631 | 12719063 | 4 | 20160614 | 20160810 | 0 | |
| 127190631 | 12719063 | 5 | 20150921 | 20160614 | 0 |