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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90130193 | 9013019 | 3 | F | 2009 | 20160714 | 20130114 | 20160720 | EXP | BR-AMGEN-BRASP2012077841 | AMGEN | 59.00 | YR | A | F | Y | 59.00000 | KG | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90130193 | 9013019 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1X/WEEK | N | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 90130193 | 9013019 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK MG, QWK | N | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||||
| 90130193 | 9013019 | 3 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1X/WEEK | N | G02463 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | ||||
| 90130193 | 9013019 | 4 | C | LIBIAN | 2 | 1.25 MG, UNK | 0 | 1.25 | MG | ||||||||||
| 90130193 | 9013019 | 5 | C | OSCAL D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | 400 MG, UNK | 0 | 400 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90130193 | 9013019 | 1 | Rheumatoid arthritis |
| 90130193 | 9013019 | 4 | Hormone therapy |
| 90130193 | 9013019 | 5 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90130193 | 9013019 | OT |
| 90130193 | 9013019 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90130193 | 9013019 | Arthralgia | |
| 90130193 | 9013019 | Hypersensitivity | |
| 90130193 | 9013019 | Immunosuppression | |
| 90130193 | 9013019 | Injection site erythema | |
| 90130193 | 9013019 | Injection site mass | |
| 90130193 | 9013019 | Pneumonia bacterial | |
| 90130193 | 9013019 | Urinary tract infection bacterial |
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 |
|---|---|---|---|---|---|---|
| 90130193 | 9013019 | 1 | 200908 | 201205 | 0 | |
| 90130193 | 9013019 | 3 | 201205 | 20121110 | 0 |