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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121178543 | 12117854 | 3 | F | 20160901 | 20160226 | 20160902 | EXP | CA-ROCHE-1630803 | ROCHE | 56.00 | YR | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121178543 | 12117854 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | U | 125276 | ||||||||||
| 121178543 | 12117854 | 2 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | STOPPED. | U | 103705 | SOLUTION FOR INFUSION | ||||||||
| 121178543 | 12117854 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 121178543 | 12117854 | 4 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | U | 0 | 50 | MG | /wk | |||||||
| 121178543 | 12117854 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | U | 0 | 40 | MG | ||||||||
| 121178543 | 12117854 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | 25 | MG | ||||||||
| 121178543 | 12117854 | 7 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 121178543 | 12117854 | 8 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | U | 0 | 5 | MG | BID | |||||||
| 121178543 | 12117854 | 9 | C | ARAVA | LEFLUNOMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121178543 | 12117854 | 1 | Rheumatoid arthritis |
| 121178543 | 12117854 | 2 | Rheumatoid arthritis |
| 121178543 | 12117854 | 3 | Rheumatoid arthritis |
| 121178543 | 12117854 | 4 | Rheumatoid arthritis |
| 121178543 | 12117854 | 5 | Rheumatoid arthritis |
| 121178543 | 12117854 | 6 | Rheumatoid arthritis |
| 121178543 | 12117854 | 7 | Rheumatoid arthritis |
| 121178543 | 12117854 | 8 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121178543 | 12117854 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121178543 | 12117854 | Abdominal discomfort | |
| 121178543 | 12117854 | Back pain | |
| 121178543 | 12117854 | Blood pressure increased | |
| 121178543 | 12117854 | Bone disorder | |
| 121178543 | 12117854 | Contusion | |
| 121178543 | 12117854 | Crying | |
| 121178543 | 12117854 | Drug ineffective | |
| 121178543 | 12117854 | Dysphagia | |
| 121178543 | 12117854 | Femur fracture | |
| 121178543 | 12117854 | Gait disturbance | |
| 121178543 | 12117854 | Haemorrhage | |
| 121178543 | 12117854 | Hypersensitivity | |
| 121178543 | 12117854 | Immune system disorder | |
| 121178543 | 12117854 | Injection site bruising | |
| 121178543 | 12117854 | Injection site erythema | |
| 121178543 | 12117854 | Injection site hypersensitivity | |
| 121178543 | 12117854 | Intervertebral disc degeneration | |
| 121178543 | 12117854 | Oedema peripheral | |
| 121178543 | 12117854 | Pain | |
| 121178543 | 12117854 | Pruritus generalised | |
| 121178543 | 12117854 | Rash | |
| 121178543 | 12117854 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 121178543 | 12117854 | 2 | 20131022 | 20140507 | 0 | |
| 121178543 | 12117854 | 4 | 20151108 | 0 | ||
| 121178543 | 12117854 | 5 | 20130506 | 20131008 | 0 | |
| 121178543 | 12117854 | 8 | 20150905 | 0 |