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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116588023 | 11658802 | 3 | F | 20140817 | 20160809 | 20151026 | 20160815 | EXP | CA-ROCHE-1576817 | ROCHE | 66.00 | YR | M | Y | 0.00000 | 20160815 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116588023 | 11658802 | 1 | PS | NAPROSYN | NAPROXEN | 1 | Unknown | U | 17581 | ||||||||||
| 116588023 | 11658802 | 2 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 0 | 5 | MG | TABLET | BID | |||||||
| 116588023 | 11658802 | 3 | SS | CELEBREX | CELECOXIB | 1 | Unknown | U | 0 | CAPSULE, HARD | |||||||||
| 116588023 | 11658802 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | ||||||||||
| 116588023 | 11658802 | 5 | SS | ENBREL | ETANERCEPT | 1 | Unknown | U | 0 | ||||||||||
| 116588023 | 11658802 | 6 | C | ARTHROTEC | DICLOFENAC SODIUMMISOPROSTOL | 1 | Oral | 0 | 75 | MG | BID | ||||||||
| 116588023 | 11658802 | 7 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Unknown | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116588023 | 11658802 | 1 | Product used for unknown indication |
| 116588023 | 11658802 | 2 | Rheumatoid arthritis |
| 116588023 | 11658802 | 3 | Arthritis |
| 116588023 | 11658802 | 4 | Rheumatoid arthritis |
| 116588023 | 11658802 | 5 | Rheumatoid arthritis |
| 116588023 | 11658802 | 6 | Arthralgia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116588023 | 11658802 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116588023 | 11658802 | Abdominal pain upper | |
| 116588023 | 11658802 | Activities of daily living impaired | |
| 116588023 | 11658802 | Anxiety | |
| 116588023 | 11658802 | Aphthous ulcer | |
| 116588023 | 11658802 | Arthralgia | |
| 116588023 | 11658802 | Arthropathy | |
| 116588023 | 11658802 | Asthenia | |
| 116588023 | 11658802 | Back pain | |
| 116588023 | 11658802 | Bone pain | |
| 116588023 | 11658802 | Contraindicated product administered | |
| 116588023 | 11658802 | Decreased activity | |
| 116588023 | 11658802 | Depression | |
| 116588023 | 11658802 | Drug ineffective | |
| 116588023 | 11658802 | Dry mouth | |
| 116588023 | 11658802 | Erythema | |
| 116588023 | 11658802 | Fatigue | |
| 116588023 | 11658802 | Hernia | |
| 116588023 | 11658802 | Injection site erythema | |
| 116588023 | 11658802 | Joint swelling | |
| 116588023 | 11658802 | Lip swelling | |
| 116588023 | 11658802 | Local swelling | |
| 116588023 | 11658802 | Malaise | |
| 116588023 | 11658802 | Muscular weakness | |
| 116588023 | 11658802 | Musculoskeletal pain | |
| 116588023 | 11658802 | Myocardial infarction | |
| 116588023 | 11658802 | Nausea | |
| 116588023 | 11658802 | Neck pain | |
| 116588023 | 11658802 | Nervousness | |
| 116588023 | 11658802 | Neuropathy peripheral | |
| 116588023 | 11658802 | Pain | |
| 116588023 | 11658802 | Pain in extremity | |
| 116588023 | 11658802 | Peripheral swelling | |
| 116588023 | 11658802 | Rash | |
| 116588023 | 11658802 | Rheumatoid arthritis | |
| 116588023 | 11658802 | Sleep disorder | |
| 116588023 | 11658802 | Swelling | |
| 116588023 | 11658802 | Tenderness |
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 |
|---|---|---|---|---|---|---|
| 116588023 | 11658802 | 2 | 20140723 | 0 | ||
| 116588023 | 11658802 | 5 | 2013 | 0 |