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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117662145 | 11766214 | 5 | F | 20151028 | 20160714 | 20151123 | 20160722 | EXP | CA-AMGEN-CANSP2015123006 | AMGEN | 68.00 | YR | E | F | Y | 0.00000 | 20160722 | OT | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117662145 | 11766214 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, QWK | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | ||||||
| 117662145 | 11766214 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 117662145 | 11766214 | 3 | SS | INSULINE | INSULIN NOS | 1 | Unknown | UNK | 0 | ORAL DROPS | |||||||||
| 117662145 | 11766214 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 10 MG, UNK | 0 | 10 | MG | TABLET | |||||||
| 117662145 | 11766214 | 5 | SS | ORENCIA | ABATACEPT | 1 | Unknown | 750 MG, UNK | 0 | 750 | MG | ||||||||
| 117662145 | 11766214 | 6 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 25 MG, UNK | 0 | 25 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117662145 | 11766214 | 1 | Rheumatoid arthritis |
| 117662145 | 11766214 | 2 | Rheumatoid arthritis |
| 117662145 | 11766214 | 3 | Product used for unknown indication |
| 117662145 | 11766214 | 4 | Rheumatoid arthritis |
| 117662145 | 11766214 | 5 | Rheumatoid arthritis |
| 117662145 | 11766214 | 6 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117662145 | 11766214 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117662145 | 11766214 | Adverse reaction | |
| 117662145 | 11766214 | Arthralgia | |
| 117662145 | 11766214 | Drug effect decreased | |
| 117662145 | 11766214 | Drug ineffective | |
| 117662145 | 11766214 | Hypoglycaemia | |
| 117662145 | 11766214 | Joint swelling | |
| 117662145 | 11766214 | Peripheral arthritis | |
| 117662145 | 11766214 | Renal haemorrhage | |
| 117662145 | 11766214 | 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 |
|---|---|---|---|---|---|---|
| 117662145 | 11766214 | 1 | 2011 | 201504 | 0 | |
| 117662145 | 11766214 | 6 | 2011 | 201504 | 0 |