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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113981193 | 11398119 | 3 | F | 2009 | 20160706 | 20150820 | 20160713 | EXP | CA-AMGEN-CANSP2014106314 | AMGEN | 46.00 | YR | A | F | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113981193 | 11398119 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 113981193 | 11398119 | 2 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 12.5 MG, QWEEK | 0 | 12.5 | MG | /wk | |||||||
| 113981193 | 11398119 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 20 MG, QWEEK | 0 | 20 | MG | /wk | |||||||
| 113981193 | 11398119 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 113981193 | 11398119 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 1 G, BID | 0 | 1 | G | BID | |||||||
| 113981193 | 11398119 | 6 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 400 MG, UNK | 0 | 400 | MG | ||||||||
| 113981193 | 11398119 | 7 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 113981193 | 11398119 | 8 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 113981193 | 11398119 | 9 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 113981193 | 11398119 | 10 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 113981193 | 11398119 | 11 | SS | RITUXIMAB | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 113981193 | 11398119 | 12 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 113981193 | 11398119 | 13 | C | RITUXAN | RITUXIMAB | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113981193 | 11398119 | 1 | Rheumatoid arthritis |
| 113981193 | 11398119 | 2 | Rheumatoid arthritis |
| 113981193 | 11398119 | 4 | Product used for unknown indication |
| 113981193 | 11398119 | 5 | Rheumatoid arthritis |
| 113981193 | 11398119 | 6 | Product used for unknown indication |
| 113981193 | 11398119 | 7 | Rheumatoid arthritis |
| 113981193 | 11398119 | 8 | Rheumatoid arthritis |
| 113981193 | 11398119 | 9 | Rheumatoid arthritis |
| 113981193 | 11398119 | 10 | Rheumatoid arthritis |
| 113981193 | 11398119 | 11 | Rheumatoid arthritis |
| 113981193 | 11398119 | 12 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113981193 | 11398119 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113981193 | 11398119 | Abdominal discomfort | |
| 113981193 | 11398119 | Activities of daily living impaired | |
| 113981193 | 11398119 | Adverse event | |
| 113981193 | 11398119 | Arthralgia | |
| 113981193 | 11398119 | Back pain | |
| 113981193 | 11398119 | Crying | |
| 113981193 | 11398119 | Depression | |
| 113981193 | 11398119 | Drug effect incomplete | |
| 113981193 | 11398119 | Drug ineffective | |
| 113981193 | 11398119 | Fatigue | |
| 113981193 | 11398119 | Joint stiffness | |
| 113981193 | 11398119 | Joint swelling | |
| 113981193 | 11398119 | Knee arthroplasty | |
| 113981193 | 11398119 | Local swelling | |
| 113981193 | 11398119 | Malaise | |
| 113981193 | 11398119 | Musculoskeletal stiffness | |
| 113981193 | 11398119 | Pain | |
| 113981193 | 11398119 | Pain in extremity | |
| 113981193 | 11398119 | Peripheral swelling | |
| 113981193 | 11398119 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 113981193 | 11398119 | 2 | 199911 | 2008 | 0 | |
| 113981193 | 11398119 | 3 | 2010 | 0 | ||
| 113981193 | 11398119 | 4 | 200205 | 2005 | 0 | |
| 113981193 | 11398119 | 5 | 1997 | 199911 | 0 | |
| 113981193 | 11398119 | 6 | 1999 | 2008 | 0 | |
| 113981193 | 11398119 | 7 | 20140826 | 0 | ||
| 113981193 | 11398119 | 12 | 20140902 | 0 |