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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117584727 | 11758472 | 7 | F | 2015 | 20160713 | 20151120 | 20160722 | EXP | GB-AMGEN-GBRSP2015110968 | AMGEN | 45.00 | YR | A | F | Y | 0.00000 | 20160722 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117584727 | 11758472 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, UNK | N | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||
| 117584727 | 11758472 | 2 | SS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | N | 103795 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | ||||||||
| 117584727 | 11758472 | 3 | C | METHOTREXATE. | METHOTREXATE | 1 | 20 MG, UNK | 0 | 20 | MG | |||||||||
| 117584727 | 11758472 | 4 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Subcutaneous | 20 MG, UNK | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117584727 | 11758472 | 1 | Rheumatoid arthritis |
| 117584727 | 11758472 | 3 | Rheumatic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117584727 | 11758472 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117584727 | 11758472 | Arthralgia | |
| 117584727 | 11758472 | Chest discomfort | |
| 117584727 | 11758472 | Condition aggravated | |
| 117584727 | 11758472 | Cough | |
| 117584727 | 11758472 | Drug ineffective | |
| 117584727 | 11758472 | Injection site erythema | |
| 117584727 | 11758472 | Injection site pain | |
| 117584727 | 11758472 | Injection site reaction | |
| 117584727 | 11758472 | Lower respiratory tract infection | |
| 117584727 | 11758472 | Nasopharyngitis | |
| 117584727 | 11758472 | Pain in extremity | |
| 117584727 | 11758472 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 117584727 | 11758472 | 1 | 20150917 | 2015 | 0 | |
| 117584727 | 11758472 | 2 | 20151210 | 0 |