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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110467745 | 11046774 | 5 | F | 2007 | 20160914 | 20150420 | 20160924 | EXP | CA-AMGEN-CANSP2015036531 | AMGEN | 16.00 | YR | T | F | Y | 0.00000 | 20160924 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110467745 | 11046774 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1 EVERY 1 WEEK | D | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 110467745 | 11046774 | 2 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 25 MG, QWK | 0 | 25 | MG | /wk | |||||||
| 110467745 | 11046774 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 2 G, BID | 0 | 2 | G | BID | |||||||
| 110467745 | 11046774 | 4 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Unknown | 200 MG, Q2MO | 0 | 200 | MG | ||||||||
| 110467745 | 11046774 | 5 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 8 MG/KG, Q4WK | 0 | 8 | MG/KG | ||||||||
| 110467745 | 11046774 | 6 | SS | ACTEMRA | TOCILIZUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 110467745 | 11046774 | 7 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 5 MG/KG, EVERY 8 WEEKS | 0 | 5 | MG/KG | ||||||||
| 110467745 | 11046774 | 8 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | 40 MG, Q2WK | 0 | 40 | MG | QOW | |||||||
| 110467745 | 11046774 | 9 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | 750 MG, EVERY 4 WEEKS | 0 | 750 | MG | ||||||||
| 110467745 | 11046774 | 10 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 20 MG, 1 EVERY 1 DAY | 0 | 20 | MG | TABLET | |||||||
| 110467745 | 11046774 | 11 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 20 MG, 1 EVERY 1 WEEK | 0 | 20 | MG | /wk | |||||||
| 110467745 | 11046774 | 12 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 110467745 | 11046774 | 13 | C | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 200 MG, BID | 0 | 200 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110467745 | 11046774 | 1 | Rheumatoid arthritis |
| 110467745 | 11046774 | 2 | Rheumatoid arthritis |
| 110467745 | 11046774 | 3 | Rheumatoid arthritis |
| 110467745 | 11046774 | 4 | Product used for unknown indication |
| 110467745 | 11046774 | 5 | Product used for unknown indication |
| 110467745 | 11046774 | 7 | Product used for unknown indication |
| 110467745 | 11046774 | 8 | Product used for unknown indication |
| 110467745 | 11046774 | 9 | Product used for unknown indication |
| 110467745 | 11046774 | 10 | Product used for unknown indication |
| 110467745 | 11046774 | 11 | Product used for unknown indication |
| 110467745 | 11046774 | 12 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110467745 | 11046774 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110467745 | 11046774 | Abdominal discomfort | |
| 110467745 | 11046774 | Arthropathy | |
| 110467745 | 11046774 | Crohn's disease | |
| 110467745 | 11046774 | Drug hypersensitivity | |
| 110467745 | 11046774 | Drug ineffective | |
| 110467745 | 11046774 | Gait disturbance | |
| 110467745 | 11046774 | Joint 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 |
|---|---|---|---|---|---|---|
| 110467745 | 11046774 | 2 | 201005 | 0 | ||
| 110467745 | 11046774 | 3 | 201203 | 201207 | 0 | |
| 110467745 | 11046774 | 4 | 201207 | 201404 | 0 | |
| 110467745 | 11046774 | 5 | 201406 | 201410 | 0 | |
| 110467745 | 11046774 | 12 | 20141030 | 0 | ||
| 110467745 | 11046774 | 13 | 201203 | 0 |