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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686521 | 12768652 | 1 | I | 20160907 | 20160921 | 20160921 | EXP | US-AMNEAL PHARMACEUTICALS-2016AMN00521 | AMNEAL | 73.00 | YR | F | Y | 74.00000 | KG | 20160921 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127686521 | 12768652 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Oral | UNK | N | 75927 | |||||||||
| 127686521 | 12768652 | 2 | SS | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | N | 0 | |||||||||||
| 127686521 | 12768652 | 3 | C | CELECOXIB. | CELECOXIB | 1 | Oral | UNK | N | 0 | TABLET | ||||||||
| 127686521 | 12768652 | 4 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | UNK | N | U | 0 | TABLET | |||||||
| 127686521 | 12768652 | 5 | C | enalapril | ENALAPRIL | 1 | Ophthalmic | UNK | N | U | 0 | TABLET | |||||||
| 127686521 | 12768652 | 6 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | UNK | N | U | 0 | TABLET | |||||||
| 127686521 | 12768652 | 7 | C | PREDNISONE. | PREDNISONE | 1 | Oral | UNK | N | U | 0 | TABLET | |||||||
| 127686521 | 12768652 | 8 | C | ERGOCALCIFEROL. | ERGOCALCIFEROL | 1 | Oral | UNK | N | 0 | TABLET | ||||||||
| 127686521 | 12768652 | 9 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | UNK | N | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127686521 | 12768652 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127686521 | 12768652 | HO |
| 127686521 | 12768652 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127686521 | 12768652 | Atrial fibrillation | |
| 127686521 | 12768652 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 127686521 | 12768652 | 1 | 20080606 | 20080611 | 0 | |
| 127686521 | 12768652 | 3 | 200501 | 20080526 | 0 | |
| 127686521 | 12768652 | 4 | 200603 | 20080611 | 0 | |
| 127686521 | 12768652 | 5 | 200506 | 20080611 | 0 | |
| 127686521 | 12768652 | 6 | 2002 | 20080611 | 0 | |
| 127686521 | 12768652 | 7 | 2000 | 20080611 | 0 | |
| 127686521 | 12768652 | 8 | 200703 | 20080611 | 0 | |
| 127686521 | 12768652 | 9 | 200703 | 20080611 | 0 |