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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892231 | 12689223 | 1 | I | 20160817 | 20160826 | 20160826 | EXP | CA-AMGEN-CANSP2016108441 | AMGEN | 47.00 | YR | A | M | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892231 | 12689223 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QWK | U | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 126892231 | 12689223 | 2 | SS | CYCLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 0 | ||||||||||
| 126892231 | 12689223 | 3 | SS | NIFEDIPINE. | NIFEDIPINE | 1 | Unknown | 30 MG, QD | 0 | 30 | MG | QD | |||||||
| 126892231 | 12689223 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 126892231 | 12689223 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 1 MG, BID | 0 | 1 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126892231 | 12689223 | 1 | Rheumatoid arthritis |
| 126892231 | 12689223 | 2 | Product used for unknown indication |
| 126892231 | 12689223 | 3 | Product used for unknown indication |
| 126892231 | 12689223 | 4 | Product used for unknown indication |
| 126892231 | 12689223 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126892231 | 12689223 | OT |
| 126892231 | 12689223 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126892231 | 12689223 | Antinuclear antibody positive | |
| 126892231 | 12689223 | Arrhythmia | |
| 126892231 | 12689223 | Arthritis | |
| 126892231 | 12689223 | Back pain | |
| 126892231 | 12689223 | Blood creatinine increased | |
| 126892231 | 12689223 | Cardiac failure congestive | |
| 126892231 | 12689223 | Cardiomyopathy | |
| 126892231 | 12689223 | Depression | |
| 126892231 | 12689223 | Dry eye | |
| 126892231 | 12689223 | Dry mouth | |
| 126892231 | 12689223 | Dyspnoea | |
| 126892231 | 12689223 | Gait disturbance | |
| 126892231 | 12689223 | Gastrooesophageal reflux disease | |
| 126892231 | 12689223 | Hypoaesthesia | |
| 126892231 | 12689223 | Impaired healing | |
| 126892231 | 12689223 | Infection | |
| 126892231 | 12689223 | Infusion related reaction | |
| 126892231 | 12689223 | Intervertebral disc protrusion | |
| 126892231 | 12689223 | Kyphosis | |
| 126892231 | 12689223 | Mixed connective tissue disease | |
| 126892231 | 12689223 | Muscular weakness | |
| 126892231 | 12689223 | Onychomycosis | |
| 126892231 | 12689223 | Osteoarthritis | |
| 126892231 | 12689223 | Pain | |
| 126892231 | 12689223 | Photosensitivity reaction | |
| 126892231 | 12689223 | Raynaud's phenomenon | |
| 126892231 | 12689223 | Renal impairment | |
| 126892231 | 12689223 | Scar | |
| 126892231 | 12689223 | Sclerodactylia | |
| 126892231 | 12689223 | Scleroderma | |
| 126892231 | 12689223 | Scoliosis | |
| 126892231 | 12689223 | Sensory loss | |
| 126892231 | 12689223 | Skin hypertrophy | |
| 126892231 | 12689223 | Skin sensitisation | |
| 126892231 | 12689223 | Skin ulcer | |
| 126892231 | 12689223 | Telangiectasia | |
| 126892231 | 12689223 | Tenderness | |
| 126892231 | 12689223 | Vasculitis | |
| 126892231 | 12689223 | Ventricular dysfunction | |
| 126892231 | 12689223 | Vertebral foraminal stenosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |