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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121903855 | 12190385 | 5 | F | 2016 | 20160801 | 20160318 | 20160809 | PER | US-AMGEN-USASL2016030449 | AMGEN | 48.00 | YR | A | F | Y | 88.44000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121903855 | 12190385 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, ONCE WEEKLY | Y | 1062646 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121903855 | 12190385 | 1 | Rheumatoid arthritis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121903855 | 12190385 | Contusion | Contusion |
| 121903855 | 12190385 | Drug ineffective | |
| 121903855 | 12190385 | Erythema | Erythema |
| 121903855 | 12190385 | Head discomfort | |
| 121903855 | 12190385 | Hepatic enzyme increased | |
| 121903855 | 12190385 | Injection site bruising | |
| 121903855 | 12190385 | Injection site erythema | |
| 121903855 | 12190385 | Injection site induration | |
| 121903855 | 12190385 | Injection site mass | |
| 121903855 | 12190385 | Injection site pain | |
| 121903855 | 12190385 | Injection site rash | |
| 121903855 | 12190385 | Injection site reaction | |
| 121903855 | 12190385 | Injection site swelling | |
| 121903855 | 12190385 | Injection site warmth | |
| 121903855 | 12190385 | Pruritus | Pruritus |
| 121903855 | 12190385 | Sinusitis | |
| 121903855 | 12190385 | Skin induration | Skin induration |
| 121903855 | 12190385 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 121903855 | 12190385 | 1 | 201602 | 0 |