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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126826161 | 12682616 | 1 | I | 20160210 | 20160825 | 20160825 | EXP | CA-AMGEN-CANSP2016018624 | AMGEN | 54.00 | YR | A | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126826161 | 12682616 | 1 | PS | ENBREL | ETANERCEPT | 1 | Unknown | 50 MG, WEEKLY | N | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 126826161 | 12682616 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 4 | SS | ARAVA | LEFLUNOMIDE | 1 | Unknown | 20 MG, DAILY | 0 | 20 | MG | TABLET | QD | ||||||
| 126826161 | 12682616 | 5 | SS | CIMZIA | CERTOLIZUMAB PEGOL | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 7 | SS | ORENCIA | ABATACEPT | 1 | Unknown | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 8 | SS | PLAQUENIL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 200 MG, BID | 0 | 200 | MG | TABLET | BID | ||||||
| 126826161 | 12682616 | 9 | SS | REMICADE | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||||
| 126826161 | 12682616 | 10 | SS | SIMPONI | GOLIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 11 | SS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | UNK | 0 | SOLUTION FOR INFUSION | |||||||||
| 126826161 | 12682616 | 12 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Unknown | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 13 | C | MELOXICAM. | MELOXICAM | 1 | Unknown | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 14 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 25 MG/ML, WEEKLY | 0 | /wk | |||||||||
| 126826161 | 12682616 | 15 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 126826161 | 12682616 | 16 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | 20 MG, QD | 0 | 20 | MG | QD | ||||||||
| 126826161 | 12682616 | 17 | C | TYLENOL WITH CODEINE | ACETAMINOPHENCODEINE PHOSPHATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126826161 | 12682616 | 1 | Rheumatoid arthritis |
| 126826161 | 12682616 | 2 | Rheumatoid arthritis |
| 126826161 | 12682616 | 3 | Rheumatoid arthritis |
| 126826161 | 12682616 | 4 | Rheumatoid arthritis |
| 126826161 | 12682616 | 5 | Product used for unknown indication |
| 126826161 | 12682616 | 6 | Rheumatoid arthritis |
| 126826161 | 12682616 | 7 | Rheumatoid arthritis |
| 126826161 | 12682616 | 8 | Rheumatoid arthritis |
| 126826161 | 12682616 | 9 | Rheumatoid arthritis |
| 126826161 | 12682616 | 10 | Product used for unknown indication |
| 126826161 | 12682616 | 11 | Rheumatoid arthritis |
| 126826161 | 12682616 | 12 | Rheumatoid arthritis |
| 126826161 | 12682616 | 13 | Rheumatoid arthritis |
| 126826161 | 12682616 | 14 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126826161 | 12682616 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126826161 | 12682616 | Activities of daily living impaired | |
| 126826161 | 12682616 | Arthralgia | |
| 126826161 | 12682616 | C-reactive protein abnormal | |
| 126826161 | 12682616 | Condition aggravated | |
| 126826161 | 12682616 | Drug ineffective | |
| 126826161 | 12682616 | Drug intolerance | |
| 126826161 | 12682616 | Fatigue | |
| 126826161 | 12682616 | Gait disturbance | |
| 126826161 | 12682616 | Joint swelling | |
| 126826161 | 12682616 | Malaise | |
| 126826161 | 12682616 | Pain | |
| 126826161 | 12682616 | Pain in extremity | |
| 126826161 | 12682616 | Peripheral swelling | |
| 126826161 | 12682616 | Red blood cell sedimentation rate increased | |
| 126826161 | 12682616 | Rheumatoid arthritis | |
| 126826161 | 12682616 | Somnolence | |
| 126826161 | 12682616 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 126826161 | 12682616 | 1 | 200310 | 2006 | 0 | |
| 126826161 | 12682616 | 16 | 20030625 | 200310 | 0 |