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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89867955 | 8986795 | 5 | F | 20160721 | 20121227 | 20160725 | EXP | BR-AMGEN-BRASP2012083281 | AMGEN | 44.00 | YR | A | F | Y | 58.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 89867955 | 8986795 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE WEEKLY | N | H31342 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 89867955 | 8986795 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | 25 MG, ONCE WEEKLY | 0 | 25 | MG | TABLET | /wk | |||||||
| 89867955 | 8986795 | 3 | C | PREDNISONE. | PREDNISONE | 1 | 5 MG, 1 TABLET ONCE A DAY | 0 | 5 | MG | QD | ||||||||
| 89867955 | 8986795 | 4 | C | CALCIUM | CALCIUM | 1 | 1 DF, 1 TABLET ONCE A DAY | 0 | 1 | DF | QD | ||||||||
| 89867955 | 8986795 | 5 | C | CALCIUM | CALCIUM | 1 | Oral | 500 MG, 1 TABLET ONCE A DAY | 0 | 500 | MG | QD | |||||||
| 89867955 | 8986795 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | 1 DF, 1 TABLET ONCE A WEEK | 0 | 1 | DF | TABLET | /wk | |||||||
| 89867955 | 8986795 | 7 | C | MELOCOX | 2 | Oral | 15 MG, 1 TABLET | 0 | 15 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 89867955 | 8986795 | 1 | Rheumatoid arthritis |
| 89867955 | 8986795 | 7 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 89867955 | 8986795 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 89867955 | 8986795 | Injection site erythema | |
| 89867955 | 8986795 | Injection site haematoma | |
| 89867955 | 8986795 | Injection site pain | |
| 89867955 | 8986795 | Injection site pruritus | |
| 89867955 | 8986795 | Injection site urticaria | |
| 89867955 | 8986795 | Joint 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 |
|---|---|---|---|---|---|---|
| 89867955 | 8986795 | 1 | 201207 | 0 |