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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118051076 | 11805107 | 6 | F | 2015 | 20160728 | 20151206 | 20160803 | PER | US-AMGEN-USASL2015129295 | AMGEN | 48.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118051076 | 11805107 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | U | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 118051076 | 11805107 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK UNK, QWK | U | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118051076 | 11805107 | 1 | Ankylosing spondylitis |
| 118051076 | 11805107 | 2 | Spondyloarthropathy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118051076 | 11805107 | Arthralgia | |
| 118051076 | 11805107 | Back pain | |
| 118051076 | 11805107 | Inappropriate schedule of drug administration | |
| 118051076 | 11805107 | Injection site erythema | |
| 118051076 | 11805107 | Injection site pain | |
| 118051076 | 11805107 | Injection site pruritus | |
| 118051076 | 11805107 | Injection site reaction | |
| 118051076 | 11805107 | Injection site swelling | |
| 118051076 | 11805107 | Mobility decreased | |
| 118051076 | 11805107 | Nasopharyngitis | |
| 118051076 | 11805107 | Pain in extremity | |
| 118051076 | 11805107 | Rash papular | |
| 118051076 | 11805107 | Rash pruritic |
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 |
|---|---|---|---|---|---|---|
| 118051076 | 11805107 | 1 | 201511 | 0 | ||
| 118051076 | 11805107 | 2 | 20160126 | 0 |