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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126900661 | 12690066 | 1 | I | 20160817 | 20160826 | 20160826 | EXP | CA-AMGEN-CANSP2016108107 | AMGEN | 51.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126900661 | 12690066 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, QWK | U | 103795 | 50 | MG | UNKNOWN FORMULATION | /wk | |||||
| 126900661 | 12690066 | 2 | SS | CICLOSPORIN | CYCLOSPORINE | 1 | Unknown | UNK | 0 | ||||||||||
| 126900661 | 12690066 | 3 | SS | NIFEDIPINE. | NIFEDIPINE | 1 | Unknown | 30 MG, QD | 0 | 30 | MG | QD | |||||||
| 126900661 | 12690066 | 4 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 126900661 | 12690066 | 5 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 1 MG, BID | 0 | 1 | MG | CAPSULE | BID | ||||||
| 126900661 | 12690066 | 6 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 2 MG, BID | 0 | 2 | MG | CAPSULE | BID | ||||||
| 126900661 | 12690066 | 7 | C | ALENDRONATE SODIUM. | ALENDRONATE SODIUM | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 8 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | UNK | 0 | CAPSULE | ||||||||||
| 126900661 | 12690066 | 9 | C | ARAVA | LEFLUNOMIDE | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 10 | C | ASA | ASPIRIN | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 11 | C | CARVEDILOL. | CARVEDILOL | 1 | UNK | 0 | TABLET | ||||||||||
| 126900661 | 12690066 | 12 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | 0 | TABLET | ||||||||||
| 126900661 | 12690066 | 13 | C | DEQUALINIUM | DEQUALINIUM | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 14 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 15 | C | EZETROL | EZETIMIBE | 1 | UNK | 0 | TABLET | ||||||||||
| 126900661 | 12690066 | 16 | C | FOSAVANCE | ALENDRONATE SODIUMCHOLECALCIFEROL | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 17 | C | GABAPENTIN. | GABAPENTIN | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 18 | C | INFLIXIMAB | INFLIXIMAB | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 19 | C | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 126900661 | 12690066 | 20 | C | PROGRAF | TACROLIMUSTACROLIMUS ANHYDROUS | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 21 | C | RABEPRAZOLE | RABEPRAZOLE | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 22 | C | RAMIPRIL. | RAMIPRIL | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 23 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | UNK | 0 | TABLET | ||||||||||
| 126900661 | 12690066 | 24 | C | VALPROATE SEMISODIUM | DIVALPROEX SODIUM | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 25 | C | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126900661 | 12690066 | 26 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126900661 | 12690066 | 1 | Rheumatoid arthritis |
| 126900661 | 12690066 | 2 | Product used for unknown indication |
| 126900661 | 12690066 | 3 | Product used for unknown indication |
| 126900661 | 12690066 | 4 | Product used for unknown indication |
| 126900661 | 12690066 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126900661 | 12690066 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126900661 | 12690066 | Antinuclear antibody positive | |
| 126900661 | 12690066 | Arrhythmia | |
| 126900661 | 12690066 | Arthritis | |
| 126900661 | 12690066 | Back pain | |
| 126900661 | 12690066 | Blood creatinine increased | |
| 126900661 | 12690066 | Cardiac failure congestive | |
| 126900661 | 12690066 | Cardiomyopathy | |
| 126900661 | 12690066 | Depression | |
| 126900661 | 12690066 | Dry eye | |
| 126900661 | 12690066 | Dry mouth | |
| 126900661 | 12690066 | Dyspnoea | |
| 126900661 | 12690066 | Gait disturbance | |
| 126900661 | 12690066 | Gastrooesophageal reflux disease | |
| 126900661 | 12690066 | Hypoaesthesia | |
| 126900661 | 12690066 | Impaired healing | |
| 126900661 | 12690066 | Infusion related reaction | |
| 126900661 | 12690066 | Kyphosis | |
| 126900661 | 12690066 | Left ventricular dysfunction | |
| 126900661 | 12690066 | Mixed connective tissue disease | |
| 126900661 | 12690066 | Muscular weakness | |
| 126900661 | 12690066 | Onycholysis | |
| 126900661 | 12690066 | Onychomycosis | |
| 126900661 | 12690066 | Osteoarthritis | |
| 126900661 | 12690066 | Pain of skin | |
| 126900661 | 12690066 | Raynaud's phenomenon | |
| 126900661 | 12690066 | Renal impairment | |
| 126900661 | 12690066 | Scar | |
| 126900661 | 12690066 | Sclerodactylia | |
| 126900661 | 12690066 | Scleroderma | |
| 126900661 | 12690066 | Scoliosis | |
| 126900661 | 12690066 | Skin hypertrophy | |
| 126900661 | 12690066 | Skin ulcer | |
| 126900661 | 12690066 | Telangiectasia | |
| 126900661 | 12690066 | Tenderness | |
| 126900661 | 12690066 | Vertebral foraminal stenosis | |
| 126900661 | 12690066 | Wound complication |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |