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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125644492 | 12564449 | 2 | F | 20160719 | 20160718 | 20160726 | EXP | CA-AMGEN-CANSP2015018521 | AMGEN | 59.00 | YR | A | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125644492 | 12564449 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1 EVERY 1 WEEK | U | 103795 | 50 | MG | SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE | /wk | |||||
| 125644492 | 12564449 | 2 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 125644492 | 12564449 | 3 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 25 MG, QWK | 0 | 25 | MG | /wk | |||||||
| 125644492 | 12564449 | 4 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 125644492 | 12564449 | 5 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | TABLET | BID | ||||||
| 125644492 | 12564449 | 6 | SS | XELJANZ | TOFACITINIB CITRATE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | TABLET | BID | ||||||
| 125644492 | 12564449 | 7 | SS | ASA | ASPIRIN | 1 | Unknown | UNK | 0 | ||||||||||
| 125644492 | 12564449 | 8 | C | CALCITE D | CALCIUM CARBONATE | 1 | 500 MG + 1000 MG DIE | 0 | TABLET | ||||||||||
| 125644492 | 12564449 | 9 | C | CITALOPRAM | CITALOPRAM HYDROBROMIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125644492 | 12564449 | 10 | C | DOMPERIDONE | DOMPERIDONE | 1 | UNK | 0 | TABLET | ||||||||||
| 125644492 | 12564449 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | 5 MG, 6/7 | 0 | 5 | MG | |||||||||
| 125644492 | 12564449 | 12 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | CAPSULE | ||||||||||
| 125644492 | 12564449 | 13 | C | GLICLAZIDE | GLICLAZIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125644492 | 12564449 | 14 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 125644492 | 12564449 | 15 | C | NIFEDIPINE. | NIFEDIPINE | 1 | UNK | 0 | |||||||||||
| 125644492 | 12564449 | 16 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 125644492 | 12564449 | 17 | C | RISEDRONATE | RISEDRONATE SODIUM | 1 | 35 MG ON TUESDAY | 0 | 35 | MG | |||||||||
| 125644492 | 12564449 | 18 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | UNK | 0 | |||||||||||
| 125644492 | 12564449 | 19 | C | TYLENOL | ACETAMINOPHEN | 1 | 650 MG, 2 TABLETS BID | 0 | 650 | MG | TABLET | BID | |||||||
| 125644492 | 12564449 | 20 | C | RISEDRONATE SODIUM. | RISEDRONATE SODIUM | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125644492 | 12564449 | 1 | Rheumatoid arthritis |
| 125644492 | 12564449 | 2 | Rheumatoid arthritis |
| 125644492 | 12564449 | 3 | Rheumatoid arthritis |
| 125644492 | 12564449 | 4 | Rheumatoid arthritis |
| 125644492 | 12564449 | 5 | Rheumatoid arthritis |
| 125644492 | 12564449 | 6 | Rheumatoid arthritis |
| 125644492 | 12564449 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125644492 | 12564449 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125644492 | 12564449 | Arthralgia | |
| 125644492 | 12564449 | Asthenia | |
| 125644492 | 12564449 | Back pain | |
| 125644492 | 12564449 | Bursitis | |
| 125644492 | 12564449 | C-reactive protein abnormal | |
| 125644492 | 12564449 | Drug ineffective | |
| 125644492 | 12564449 | Drug intolerance | |
| 125644492 | 12564449 | Dry mouth | |
| 125644492 | 12564449 | Joint range of motion decreased | |
| 125644492 | 12564449 | Lip dry | |
| 125644492 | 12564449 | Liver disorder | |
| 125644492 | 12564449 | Local swelling | |
| 125644492 | 12564449 | Lung disorder | |
| 125644492 | 12564449 | Muscle spasms | |
| 125644492 | 12564449 | Musculoskeletal pain | |
| 125644492 | 12564449 | Musculoskeletal stiffness | |
| 125644492 | 12564449 | Night sweats | |
| 125644492 | 12564449 | Obesity | |
| 125644492 | 12564449 | Oedema | |
| 125644492 | 12564449 | Oedema peripheral | |
| 125644492 | 12564449 | Osteoarthritis | |
| 125644492 | 12564449 | Pain | |
| 125644492 | 12564449 | Pain in extremity | |
| 125644492 | 12564449 | Paraesthesia | |
| 125644492 | 12564449 | Peripheral swelling | |
| 125644492 | 12564449 | Peripheral venous disease | |
| 125644492 | 12564449 | Red blood cell sedimentation rate abnormal | |
| 125644492 | 12564449 | 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 |
|---|---|---|---|---|---|---|
| 125644492 | 12564449 | 1 | 20140529 | 0 | ||
| 125644492 | 12564449 | 6 | 20150304 | 0 |