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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115194568 | 11519456 | 8 | F | 201509 | 20160816 | 20150918 | 20160822 | EXP | CA-AMGEN-CANSP2015095516 | AMGEN | 43.00 | YR | A | F | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115194568 | 11519456 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 115194568 | 11519456 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | 25 MG, UNK | 0 | 25 | MG | ||||||||
| 115194568 | 11519456 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 1 G, BID | 0 | 1 | G | BID | |||||||
| 115194568 | 11519456 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 5 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 6 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 7 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 8 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 9 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 10 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 11 | SS | SIMPONI | GOLIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 12 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 115194568 | 11519456 | 13 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 400 MG, QD | 0 | 400 | MG | QD | |||||||
| 115194568 | 11519456 | 14 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 15 | SS | FOLIC ACID. | FOLIC ACID | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 16 | SS | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 17 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 18 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 115194568 | 11519456 | 19 | C | FOSAMAX | ALENDRONATE SODIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 115194568 | 11519456 | 20 | C | REACTINE | CETIRIZINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 115194568 | 11519456 | 21 | C | XELJANZ | TOFACITINIB CITRATE | 1 | UNK | 0 | |||||||||||
| 115194568 | 11519456 | 22 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115194568 | 11519456 | 1 | Rheumatoid arthritis |
| 115194568 | 11519456 | 2 | Rheumatoid arthritis |
| 115194568 | 11519456 | 3 | Rheumatoid arthritis |
| 115194568 | 11519456 | 4 | Rheumatoid arthritis |
| 115194568 | 11519456 | 5 | Rheumatoid arthritis |
| 115194568 | 11519456 | 6 | Rheumatoid arthritis |
| 115194568 | 11519456 | 7 | Rheumatoid arthritis |
| 115194568 | 11519456 | 8 | Rheumatoid arthritis |
| 115194568 | 11519456 | 9 | Rheumatoid arthritis |
| 115194568 | 11519456 | 10 | Rheumatoid arthritis |
| 115194568 | 11519456 | 11 | Rheumatoid arthritis |
| 115194568 | 11519456 | 12 | Rheumatoid arthritis |
| 115194568 | 11519456 | 13 | Rheumatoid arthritis |
| 115194568 | 11519456 | 14 | Rheumatoid arthritis |
| 115194568 | 11519456 | 15 | Rheumatoid arthritis |
| 115194568 | 11519456 | 16 | Rheumatoid arthritis |
| 115194568 | 11519456 | 17 | Rheumatoid arthritis |
| 115194568 | 11519456 | 18 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115194568 | 11519456 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115194568 | 11519456 | Abdominal discomfort | |
| 115194568 | 11519456 | Adverse event | |
| 115194568 | 11519456 | Alopecia | |
| 115194568 | 11519456 | Condition aggravated | |
| 115194568 | 11519456 | Drug ineffective | |
| 115194568 | 11519456 | Drug intolerance | |
| 115194568 | 11519456 | Fatigue | |
| 115194568 | 11519456 | Glossodynia | |
| 115194568 | 11519456 | Hand deformity | |
| 115194568 | 11519456 | Hip arthroplasty | |
| 115194568 | 11519456 | Knee arthroplasty | |
| 115194568 | 11519456 | Pain | |
| 115194568 | 11519456 | Pemphigus | |
| 115194568 | 11519456 | Swelling | |
| 115194568 | 11519456 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 115194568 | 11519456 | 2 | 2006 | 2016 | 0 | |
| 115194568 | 11519456 | 3 | 2006 | 2007 | 0 | |
| 115194568 | 11519456 | 7 | 201005 | 201103 | 0 | |
| 115194568 | 11519456 | 10 | 2009 | 2010 | 0 | |
| 115194568 | 11519456 | 13 | 2006 | 0 |