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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113797484 | 11379748 | 4 | F | 20160825 | 20150814 | 20160826 | EXP | CA-ROCHE-1620025 | ROCHE | 63.00 | YR | F | Y | 0.00000 | 20160826 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113797484 | 11379748 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | THERAPY DURATION: 1 YEAR | U | NOT REPORTED | 125276 | 8 | MG/KG | SOLUTION FOR INFUSION | |||||
| 113797484 | 11379748 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | U | 0 | 50 | MG | /wk | |||||||
| 113797484 | 11379748 | 3 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | U | 0 | 200 | MG | ||||||||
| 113797484 | 11379748 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | U | 0 | 20 | MG | TABLET | |||||||
| 113797484 | 11379748 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 0 | 40 | MG | QOW | |||||||
| 113797484 | 11379748 | 6 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | U | 0 | 500 | MG | POWDER FOR INFUSION | |||||||
| 113797484 | 11379748 | 7 | SS | KINERET | ANAKINRA | 1 | Subcutaneous | U | 0 | 100 | MG | ||||||||
| 113797484 | 11379748 | 8 | SS | METHOTREXATE. | METHOTREXATE | 1 | Oral | U | 0 | ||||||||||
| 113797484 | 11379748 | 9 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | U | 0 | 12.5 | MG | ||||||||
| 113797484 | 11379748 | 10 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Unknown | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113797484 | 11379748 | 1 | Product used for unknown indication |
| 113797484 | 11379748 | 2 | Rheumatoid arthritis |
| 113797484 | 11379748 | 3 | Product used for unknown indication |
| 113797484 | 11379748 | 4 | Product used for unknown indication |
| 113797484 | 11379748 | 5 | Product used for unknown indication |
| 113797484 | 11379748 | 6 | Product used for unknown indication |
| 113797484 | 11379748 | 7 | Product used for unknown indication |
| 113797484 | 11379748 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113797484 | 11379748 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113797484 | 11379748 | Cutaneous vasculitis | |
| 113797484 | 11379748 | Drug ineffective | |
| 113797484 | 11379748 | Drug intolerance | |
| 113797484 | 11379748 | Oral mucosal exfoliation | |
| 113797484 | 11379748 | Rash | |
| 113797484 | 11379748 | Rheumatoid arthritis | |
| 113797484 | 11379748 | Secretion discharge | |
| 113797484 | 11379748 | Spinal column stenosis |
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 |
|---|---|---|---|---|---|---|
| 113797484 | 11379748 | 1 | 201101 | 201203 | 0 | |
| 113797484 | 11379748 | 2 | 200806 | 0 | ||
| 113797484 | 11379748 | 4 | 200902 | 200909 | 0 | |
| 113797484 | 11379748 | 5 | 200809 | 0 | ||
| 113797484 | 11379748 | 6 | 201011 | 0 | ||
| 113797484 | 11379748 | 7 | 201203 | 201406 | 0 | |
| 113797484 | 11379748 | 9 | 201404 | 0 |