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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90965775 | 9096577 | 5 | F | 2013 | 20160722 | 20130211 | 20160727 | EXP | BR-AMGEN-BRASP2013008827 | AMGEN | 35.00 | YR | A | M | Y | 80.00000 | KG | 20160727 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90965775 | 9096577 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE WEEKLY | G30365 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 90965775 | 9096577 | 2 | C | METHOTREXATE. | METHOTREXATE | 1 | 25 MG, ONCE WEEKLY (ON SATURDAYS) | 0 | 25 | MG | /wk | ||||||||
| 90965775 | 9096577 | 3 | C | ARAVA | LEFLUNOMIDE | 1 | 20 MG, UNK | 0 | 20 | MG | |||||||||
| 90965775 | 9096577 | 4 | C | ARAVA | LEFLUNOMIDE | 1 | UNK UNK, WEEKLY (STRENGTH 20 MG) | 0 | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90965775 | 9096577 | 1 | Rheumatoid arthritis |
| 90965775 | 9096577 | 2 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90965775 | 9096577 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90965775 | 9096577 | Depression | |
| 90965775 | 9096577 | Erythema | |
| 90965775 | 9096577 | Hypersensitivity | |
| 90965775 | 9096577 | Injection site erythema | |
| 90965775 | 9096577 | Injection site mass | |
| 90965775 | 9096577 | Injection site pain | |
| 90965775 | 9096577 | Injection site pruritus | |
| 90965775 | 9096577 | Ligament disorder | |
| 90965775 | 9096577 | Product quality issue | |
| 90965775 | 9096577 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 90965775 | 9096577 | 1 | 20130115 | 0 |