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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115827533 | 11582753 | 3 | F | 20160812 | 20151001 | 20160818 | EXP | CA-ROCHE-1638001 | ROCHE | 43.00 | YR | F | Y | 0.00000 | 20160818 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115827533 | 11582753 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | N | 125276 | ||||||||||
| 115827533 | 11582753 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | N | 103705 | ||||||||||
| 115827533 | 11582753 | 3 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | N | 0 | ||||||||||
| 115827533 | 11582753 | 4 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | N | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 115827533 | 11582753 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 115827533 | 11582753 | 6 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | N | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 115827533 | 11582753 | 7 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | N | 0 | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | |||||||||
| 115827533 | 11582753 | 8 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | N | 0 | SOLUTION FOR INFUSION | |||||||||
| 115827533 | 11582753 | 9 | SS | ARAVA | LEFLUNOMIDE | 1 | Oral | N | 0 | TABLET | |||||||||
| 115827533 | 11582753 | 10 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | N | 0 | ||||||||||
| 115827533 | 11582753 | 11 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | N | 0 | ||||||||||
| 115827533 | 11582753 | 12 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | N | 0 | ||||||||||
| 115827533 | 11582753 | 13 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | ||||||||||
| 115827533 | 11582753 | 14 | SS | FOLIC ACID. | FOLIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 115827533 | 11582753 | 15 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 115827533 | 11582753 | 16 | SS | REACTINE (CANADA) | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 115827533 | 11582753 | 17 | SS | SULFATHALIDINE | PHTHALYLSULFATHIAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 115827533 | 11582753 | 18 | SS | HYDROXYCHLOROQUINE SULFATE. | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 115827533 | 11582753 | 19 | SS | FOSAMAX | ALENDRONATE SODIUM | 1 | Oral | U | 0 | TABLET | |||||||||
| 115827533 | 11582753 | 20 | C | XELJANZ | TOFACITINIB CITRATE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115827533 | 11582753 | 1 | Rheumatoid arthritis |
| 115827533 | 11582753 | 2 | Rheumatoid arthritis |
| 115827533 | 11582753 | 3 | Rheumatoid arthritis |
| 115827533 | 11582753 | 4 | Rheumatoid arthritis |
| 115827533 | 11582753 | 5 | Rheumatoid arthritis |
| 115827533 | 11582753 | 6 | Rheumatoid arthritis |
| 115827533 | 11582753 | 7 | Rheumatoid arthritis |
| 115827533 | 11582753 | 8 | Rheumatoid arthritis |
| 115827533 | 11582753 | 9 | Rheumatoid arthritis |
| 115827533 | 11582753 | 10 | Rheumatoid arthritis |
| 115827533 | 11582753 | 11 | Rheumatoid arthritis |
| 115827533 | 11582753 | 12 | Rheumatoid arthritis |
| 115827533 | 11582753 | 13 | Rheumatoid arthritis |
| 115827533 | 11582753 | 14 | Rheumatoid arthritis |
| 115827533 | 11582753 | 15 | Rheumatoid arthritis |
| 115827533 | 11582753 | 16 | Rheumatoid arthritis |
| 115827533 | 11582753 | 17 | Product used for unknown indication |
| 115827533 | 11582753 | 18 | Rheumatoid arthritis |
| 115827533 | 11582753 | 19 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115827533 | 11582753 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115827533 | 11582753 | Abdominal discomfort | |
| 115827533 | 11582753 | Alopecia | |
| 115827533 | 11582753 | Drug ineffective | |
| 115827533 | 11582753 | Drug intolerance | |
| 115827533 | 11582753 | Fatigue | |
| 115827533 | 11582753 | Glossodynia | |
| 115827533 | 11582753 | Hand deformity | |
| 115827533 | 11582753 | Infusion related reaction | |
| 115827533 | 11582753 | Pain | |
| 115827533 | 11582753 | Pemphigus | |
| 115827533 | 11582753 | Rash | |
| 115827533 | 11582753 | Swelling | |
| 115827533 | 11582753 | Systemic lupus erythematosus |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |