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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119152874 | 11915287 | 4 | F | 201601 | 20160725 | 20160114 | 20160803 | PER | US-AMGEN-USASL2016001894 | AMGEN | 21.00 | YR | A | F | Y | 0.00000 | 20160803 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119152874 | 11915287 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, WEEKLY | U | 1061319 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119152874 | 11915287 | 1 | Psoriatic arthropathy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119152874 | 11915287 | Device issue | |
| 119152874 | 11915287 | Injection site erythema | |
| 119152874 | 11915287 | Injection site induration | |
| 119152874 | 11915287 | Injection site mass | |
| 119152874 | 11915287 | Injection site pain | |
| 119152874 | 11915287 | Injection site pruritus | |
| 119152874 | 11915287 | Injection site swelling | |
| 119152874 | 11915287 | Injection site warmth | |
| 119152874 | 11915287 | Injury associated with device | |
| 119152874 | 11915287 | Rash |
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 |
|---|---|---|---|---|---|---|
| 119152874 | 11915287 | 1 | 201512 | 0 |