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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121935645 | 12193564 | 5 | F | 2016 | 20160727 | 20160320 | 20160801 | PER | US-AMGEN-USASL2016031981 | AMGEN | 49.00 | YR | A | F | Y | 0.00000 | 20160801 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121935645 | 12193564 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, WEEKLY | 971.223023 | MG | Y | 1062887 | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121935645 | 12193564 | 1 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121935645 | 12193564 | HO |
| 121935645 | 12193564 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121935645 | 12193564 | Cardiac failure congestive | |
| 121935645 | 12193564 | Decreased appetite | |
| 121935645 | 12193564 | Deformity | |
| 121935645 | 12193564 | Diarrhoea | |
| 121935645 | 12193564 | Drug effect incomplete | |
| 121935645 | 12193564 | Dysgeusia | |
| 121935645 | 12193564 | Fatigue | |
| 121935645 | 12193564 | Feeling abnormal | |
| 121935645 | 12193564 | Fluid retention | |
| 121935645 | 12193564 | Gait disturbance | |
| 121935645 | 12193564 | Increased appetite | |
| 121935645 | 12193564 | Injection site bruising | |
| 121935645 | 12193564 | Injection site discomfort | |
| 121935645 | 12193564 | Joint swelling | |
| 121935645 | 12193564 | Mobility decreased | |
| 121935645 | 12193564 | Muscle spasms | |
| 121935645 | 12193564 | Musculoskeletal stiffness | |
| 121935645 | 12193564 | Pain | |
| 121935645 | 12193564 | Peripheral swelling | |
| 121935645 | 12193564 | Retching | |
| 121935645 | 12193564 | Skin mass |
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 |
|---|---|---|---|---|---|---|
| 121935645 | 12193564 | 1 | 20160304 | 20160720 | 0 |