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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104218034 | 10421803 | 4 | F | 2014 | 20160721 | 20140901 | 20160727 | EXP | BR-AMGEN-BRASP2014065685 | AMGEN | 55.00 | YR | A | F | Y | 45.00000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 104218034 | 10421803 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1X/WEEK | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||||
| 104218034 | 10421803 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | J13794 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 104218034 | 10421803 | 3 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 104218034 | 10421803 | 4 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 104218034 | 10421803 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 104218034 | 10421803 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 104218034 | 10421803 | Injection site erythema | |
| 104218034 | 10421803 | Injection site pain | |
| 104218034 | 10421803 | Injection site pruritus | |
| 104218034 | 10421803 | Injection site swelling | |
| 104218034 | 10421803 | Suture related complication | |
| 104218034 | 10421803 | Tracheal stenosis |
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 |
|---|---|---|---|---|---|---|
| 104218034 | 10421803 | 1 | 20130905 | 2013 | 0 | |
| 104218034 | 10421803 | 2 | 2013 | 201402 | 0 | |
| 104218034 | 10421803 | 3 | 201407 | 0 |