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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127055391 | 12705539 | 1 | I | 20160818 | 20160901 | 20160901 | EXP | CA-ORION CORPORATION ORION PHARMA-TREX2016-1520 | ORION | 44.00 | YR | F | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127055391 | 12705539 | 1 | PS | METHOTREXATE (TRADE NAME UNKNOWN) | METHOTREXATE | 1 | Oral | 0 | 25 | MG | |||||||||
| 127055391 | 12705539 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | N | 0 | 25 | MG | BIW | |||||||
| 127055391 | 12705539 | 3 | SS | ORENCIA | ABATACEPT | 1 | Unknown | N | 0 | 1000 | MG | ||||||||
| 127055391 | 12705539 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | N | 0 | 20 | MG | TABLET | QD | ||||||
| 127055391 | 12705539 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 0 | 40 | MG | QOW | |||||||
| 127055391 | 12705539 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | N | 0 | 40 | MG | ||||||||
| 127055391 | 12705539 | 7 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | N | 0 | 40 | MG | ||||||||
| 127055391 | 12705539 | 8 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 0 | 400 | MG | TABLET | QD | |||||||
| 127055391 | 12705539 | 9 | C | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG 2 PERFUSION | 0 | ||||||||||
| 127055391 | 12705539 | 10 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | |||||||||||
| 127055391 | 12705539 | 11 | C | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127055391 | 12705539 | 2 | Rheumatoid arthritis |
| 127055391 | 12705539 | 3 | Rheumatoid arthritis |
| 127055391 | 12705539 | 4 | Rheumatoid arthritis |
| 127055391 | 12705539 | 5 | Rheumatoid arthritis |
| 127055391 | 12705539 | 8 | Rheumatoid arthritis |
| 127055391 | 12705539 | 9 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127055391 | 12705539 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127055391 | 12705539 | Drug ineffective | |
| 127055391 | 12705539 | Foot deformity | |
| 127055391 | 12705539 | Gait disturbance | |
| 127055391 | 12705539 | Treatment failure |
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 |
|---|---|---|---|---|---|---|
| 127055391 | 12705539 | 1 | 200410 | 0 | ||
| 127055391 | 12705539 | 2 | 200502 | 200512 | 0 | |
| 127055391 | 12705539 | 3 | 200811 | 200908 | 0 | |
| 127055391 | 12705539 | 4 | 200206 | 200410 | 0 | |
| 127055391 | 12705539 | 5 | 200510 | 2007 | 0 | |
| 127055391 | 12705539 | 6 | 200909 | 20160126 | 0 | |
| 127055391 | 12705539 | 7 | 2016 | 2016 | 0 | |
| 127055391 | 12705539 | 8 | 2004 | 0 | ||
| 127055391 | 12705539 | 9 | 200802 | 0 |