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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85100502 | 8510050 | 2 | F | 201203 | 20160711 | 20120413 | 20160714 | EXP | BR-AMGEN-BRASP2012021977 | AMGEN | 45.00 | YR | A | F | Y | 58.00000 | KG | 20160714 | CN | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85100502 | 8510050 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | 103795 | 50 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | /wk | ||||||
| 85100502 | 8510050 | 2 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, 1 TABLET A DAY | 0 | 5 | MG | QD | ||||||||
| 85100502 | 8510050 | 3 | C | MELOXICAM. | MELOXICAM | 1 | 15 MG, 1 TABLET AT NIGHT | 0 | 15 | MG | QD | ||||||||
| 85100502 | 8510050 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | 15 MG, WEEKLY | 0 | 15 | MG | /wk | ||||||||
| 85100502 | 8510050 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, 1 TABLET A DAY | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85100502 | 8510050 | 1 | Rheumatoid arthritis |
| 85100502 | 8510050 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 85100502 | 8510050 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85100502 | 8510050 | Blister | |
| 85100502 | 8510050 | Cough | |
| 85100502 | 8510050 | Gait disturbance | |
| 85100502 | 8510050 | Hand deformity | |
| 85100502 | 8510050 | Mouth swelling | |
| 85100502 | 8510050 | Nodule | |
| 85100502 | 8510050 | Oedema peripheral | |
| 85100502 | 8510050 | Pain | |
| 85100502 | 8510050 | Pruritus | |
| 85100502 | 8510050 | Pyrexia | |
| 85100502 | 8510050 | Swelling face | |
| 85100502 | 8510050 | Wound |
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 |
|---|---|---|---|---|---|---|
| 85100502 | 8510050 | 1 | 20120316 | 0 |