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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125627771 | 12562777 | 1 | I | 2015 | 20151006 | 20160715 | 20160715 | EXP | CA-AMGEN-CANSP2015105993 | AMGEN | 53.00 | YR | A | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125627771 | 12562777 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 125627771 | 12562777 | 2 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 125627771 | 12562777 | 3 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125627771 | 12562777 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 125627771 | 12562777 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | 0 | ||||||||||
| 125627771 | 12562777 | 6 | SS | ABATACEPT | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 125627771 | 12562777 | 7 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125627771 | 12562777 | 8 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 125627771 | 12562777 | 9 | C | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 25 MG/WEEK | 0 | 25 | MG | /wk | |||||||
| 125627771 | 12562777 | 10 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Oral | 5 MG, UNK | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125627771 | 12562777 | 1 | Rheumatoid arthritis |
| 125627771 | 12562777 | 2 | Product used for unknown indication |
| 125627771 | 12562777 | 3 | Rheumatoid arthritis |
| 125627771 | 12562777 | 4 | Rheumatoid arthritis |
| 125627771 | 12562777 | 5 | Rheumatoid arthritis |
| 125627771 | 12562777 | 6 | Product used for unknown indication |
| 125627771 | 12562777 | 7 | Rheumatoid arthritis |
| 125627771 | 12562777 | 8 | Rheumatoid arthritis |
| 125627771 | 12562777 | 9 | Rheumatoid arthritis |
| 125627771 | 12562777 | 10 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125627771 | 12562777 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125627771 | 12562777 | Anal fissure | |
| 125627771 | 12562777 | Diarrhoea | |
| 125627771 | 12562777 | Drug ineffective | |
| 125627771 | 12562777 | Drug intolerance | |
| 125627771 | 12562777 | Dyspepsia | |
| 125627771 | 12562777 | Fear | |
| 125627771 | 12562777 | Joint swelling | |
| 125627771 | 12562777 | Laboratory test abnormal | |
| 125627771 | 12562777 | Lung infection | |
| 125627771 | 12562777 | Mucosal inflammation | |
| 125627771 | 12562777 | 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 |
|---|---|---|---|---|---|---|
| 125627771 | 12562777 | 2 | 20151127 | 0 | ||
| 125627771 | 12562777 | 9 | 2009 | 0 |