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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117134093 | 11713409 | 3 | F | 2013 | 20160714 | 20151109 | 20160720 | EXP | CA-AMGEN-CANSP2015115197 | AMGEN | 65.00 | YR | E | F | Y | 0.00000 | 20160720 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117134093 | 11713409 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | UNK | U | 103795 | UNKNOWN FORMULATION | ||||||||
| 117134093 | 11713409 | 2 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | UNK | 0 | ||||||||||
| 117134093 | 11713409 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | 2 G, UNK | 0 | 2 | G | ||||||||
| 117134093 | 11713409 | 4 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117134093 | 11713409 | 5 | SS | HUMIRA | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 117134093 | 11713409 | 6 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 117134093 | 11713409 | 7 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 117134093 | 11713409 | 8 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 117134093 | 11713409 | 9 | C | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 117134093 | 11713409 | 10 | C | NAROXIN | 2 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117134093 | 11713409 | 1 | Rheumatoid arthritis |
| 117134093 | 11713409 | 2 | Product used for unknown indication |
| 117134093 | 11713409 | 3 | Product used for unknown indication |
| 117134093 | 11713409 | 4 | Product used for unknown indication |
| 117134093 | 11713409 | 5 | Product used for unknown indication |
| 117134093 | 11713409 | 6 | Product used for unknown indication |
| 117134093 | 11713409 | 7 | Product used for unknown indication |
| 117134093 | 11713409 | 8 | Product used for unknown indication |
| 117134093 | 11713409 | 9 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117134093 | 11713409 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117134093 | 11713409 | Activities of daily living impaired | |
| 117134093 | 11713409 | C-reactive protein abnormal | |
| 117134093 | 11713409 | Drug ineffective | |
| 117134093 | 11713409 | Drug intolerance | |
| 117134093 | 11713409 | Fatigue | |
| 117134093 | 11713409 | Hepatic enzyme increased | |
| 117134093 | 11713409 | Infection | |
| 117134093 | 11713409 | Knee arthroplasty | |
| 117134093 | 11713409 | Mobility decreased | |
| 117134093 | 11713409 | Mucosal inflammation | |
| 117134093 | 11713409 | Pain | |
| 117134093 | 11713409 | Synovitis |
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 |
|---|---|---|---|---|---|---|
| 117134093 | 11713409 | 3 | 2011 | 0 | ||
| 117134093 | 11713409 | 9 | 20151119 | 0 |