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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119646123 | 11964612 | 3 | F | 2012 | 20160830 | 20160127 | 20160912 | EXP | CA-ROCHE-1700523 | ROCHE | 53.00 | YR | F | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119646123 | 11964612 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | DOSE: SINGLE | U | 103705 | SOLUTION FOR INFUSION | ||||||||
| 119646123 | 11964612 | 2 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | U | 0 | TABLET | |||||||||
| 119646123 | 11964612 | 3 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | U | 0 | 20 | MG | TABLET | |||||||
| 119646123 | 11964612 | 4 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | DOSE: SINGLE | Y | 0 | |||||||||
| 119646123 | 11964612 | 5 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 119646123 | 11964612 | 6 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | U | 0 | 20 | MG | ||||||||
| 119646123 | 11964612 | 7 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | THERAPY DURATION: 3 MONTHS | U | 0 | TABLET | ||||||||
| 119646123 | 11964612 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 20 | MG | TABLET | |||||||
| 119646123 | 11964612 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | TABLET | |||||||
| 119646123 | 11964612 | 10 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | THERAPY DURATION: 2 MONTHS | U | 0 | |||||||||
| 119646123 | 11964612 | 11 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Unknown | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119646123 | 11964612 | 1 | Rheumatoid arthritis |
| 119646123 | 11964612 | 2 | Rheumatoid arthritis |
| 119646123 | 11964612 | 4 | Rheumatoid arthritis |
| 119646123 | 11964612 | 5 | Rheumatoid arthritis |
| 119646123 | 11964612 | 7 | Rheumatoid arthritis |
| 119646123 | 11964612 | 8 | Rheumatoid arthritis |
| 119646123 | 11964612 | 10 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119646123 | 11964612 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119646123 | 11964612 | Anaphylactic reaction | |
| 119646123 | 11964612 | Condition aggravated | |
| 119646123 | 11964612 | Diabetes mellitus | |
| 119646123 | 11964612 | Drug ineffective | |
| 119646123 | 11964612 | Dyspnoea | |
| 119646123 | 11964612 | Headache | |
| 119646123 | 11964612 | Liver function test abnormal | |
| 119646123 | 11964612 | Liver function test increased | |
| 119646123 | 11964612 | Pharyngeal oedema | |
| 119646123 | 11964612 | Rash | |
| 119646123 | 11964612 | Swelling | |
| 119646123 | 11964612 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 119646123 | 11964612 | 1 | 201407 | 0 | ||
| 119646123 | 11964612 | 2 | 2010 | 0 | ||
| 119646123 | 11964612 | 3 | 201209 | 201305 | 0 | |
| 119646123 | 11964612 | 4 | 201309 | 0 | ||
| 119646123 | 11964612 | 5 | 2010 | 0 | ||
| 119646123 | 11964612 | 6 | 201201 | 201307 | 0 | |
| 119646123 | 11964612 | 7 | 201205 | 201207 | 0 | |
| 119646123 | 11964612 | 10 | 201205 | 201206 | 0 | |
| 119646123 | 11964612 | 11 | 20140930 | 0 |