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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115950735 | 11595073 | 5 | F | 2011 | 20160712 | 20151006 | 20160715 | EXP | CA-AMGEN-CANSP2015102627 | AMGEN | 33.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115950735 | 11595073 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | UNK | Y | 103795 | UNKNOWN FORMULATION | ||||||||
| 115950735 | 11595073 | 2 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 115950735 | 11595073 | 3 | SS | GOLD | GOLD | 1 | Unknown | UNK | 0 | ||||||||||
| 115950735 | 11595073 | 4 | SS | REMICADE | INFLIXIMAB | 1 | Unknown | UNK | 0 | POWDER FOR SOLUTION FOR INJECTION | |||||||||
| 115950735 | 11595073 | 5 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | 8 MG, QMO | 0 | 8 | MG | /month | |||||||
| 115950735 | 11595073 | 6 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | UNK | 0 | TABLET | |||||||||
| 115950735 | 11595073 | 7 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | 0 | ||||||||||
| 115950735 | 11595073 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 115950735 | 11595073 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 3 MG, QD | 0 | 3 | MG | QD | |||||||
| 115950735 | 11595073 | 10 | SS | NAPROSYN | NAPROXEN | 1 | Unknown | UNK | 0 | ||||||||||
| 115950735 | 11595073 | 11 | SS | METHOTREXATE (METHOTREXATE SODIUM) | METHOTREXATE SODIUM | 1 | Unknown | 15 MG, QWK | 0 | 15 | MG | /wk | |||||||
| 115950735 | 11595073 | 12 | SS | RITUXAN | RITUXIMAB | 1 | Unknown | UNK | 0 | INTRAVENOUS INFUSION | |||||||||
| 115950735 | 11595073 | 13 | C | LOSEC | OMEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 115950735 | 11595073 | 14 | C | CELEXA | CITALOPRAM HYDROBROMIDE | 1 | UNK | 0 | |||||||||||
| 115950735 | 11595073 | 15 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 115950735 | 11595073 | 16 | C | CITALOPRAM HYDROBROMIDE. | CITALOPRAM HYDROBROMIDE | 1 | UNK | 0 | |||||||||||
| 115950735 | 11595073 | 17 | C | KETOPROFEN. | KETOPROFEN | 1 | 100 MG, BID | 0 | 100 | MG | BID | ||||||||
| 115950735 | 11595073 | 18 | C | ROSUVASTATIN CALCIUM. | ROSUVASTATIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 115950735 | 11595073 | 19 | C | XELJANZ | TOFACITINIB CITRATE | 1 | 5 MG, BID | 0 | 5 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115950735 | 11595073 | 1 | Product used for unknown indication |
| 115950735 | 11595073 | 2 | Product used for unknown indication |
| 115950735 | 11595073 | 3 | Rheumatoid arthritis |
| 115950735 | 11595073 | 4 | Product used for unknown indication |
| 115950735 | 11595073 | 5 | Rheumatoid arthritis |
| 115950735 | 11595073 | 6 | Rheumatoid arthritis |
| 115950735 | 11595073 | 7 | Rheumatoid arthritis |
| 115950735 | 11595073 | 8 | Rheumatoid arthritis |
| 115950735 | 11595073 | 10 | Product used for unknown indication |
| 115950735 | 11595073 | 11 | Product used for unknown indication |
| 115950735 | 11595073 | 12 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115950735 | 11595073 | HO |
| 115950735 | 11595073 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115950735 | 11595073 | Arthralgia | |
| 115950735 | 11595073 | Arthropathy | |
| 115950735 | 11595073 | Asthenia | |
| 115950735 | 11595073 | Condition aggravated | |
| 115950735 | 11595073 | Cough | |
| 115950735 | 11595073 | Drug ineffective | |
| 115950735 | 11595073 | Fatigue | |
| 115950735 | 11595073 | Fine motor skill dysfunction | |
| 115950735 | 11595073 | Goitre | |
| 115950735 | 11595073 | Headache | |
| 115950735 | 11595073 | Inflammation | |
| 115950735 | 11595073 | Joint swelling | |
| 115950735 | 11595073 | Knee arthroplasty | |
| 115950735 | 11595073 | Lower respiratory tract infection | |
| 115950735 | 11595073 | Musculoskeletal pain | |
| 115950735 | 11595073 | Musculoskeletal stiffness | |
| 115950735 | 11595073 | Nasopharyngitis | |
| 115950735 | 11595073 | Nephrolithiasis | |
| 115950735 | 11595073 | Pain | |
| 115950735 | 11595073 | Pain in extremity | |
| 115950735 | 11595073 | Peripheral swelling | |
| 115950735 | 11595073 | Rheumatoid arthritis | |
| 115950735 | 11595073 | Swelling | |
| 115950735 | 11595073 | Thyroid disorder |
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 |
|---|---|---|---|---|---|---|
| 115950735 | 11595073 | 1 | 201507 | 0 | ||
| 115950735 | 11595073 | 5 | 20150910 | 0 | ||
| 115950735 | 11595073 | 8 | 2007 | 0 | ||
| 115950735 | 11595073 | 9 | 2015 | 0 | ||
| 115950735 | 11595073 | 11 | 20150910 | 0 |