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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114908795 | 11490879 | 5 | F | 2014 | 20160712 | 20150910 | 20160719 | EXP | CA-AMGEN-CANSP2015093585 | AMGEN | 3.00 | YR | C | F | Y | 63.99000 | KG | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114908795 | 11490879 | 1 | PS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 12.5 MG, 1 EVERY 1 WEEK | U | 103795 | 12.5 | MG | UNKNOWN FORMULATION | /wk | |||||
| 114908795 | 11490879 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 25 MG, Q2WK | U | 103795 | 25 | MG | UNKNOWN FORMULATION | QOW | |||||
| 114908795 | 11490879 | 3 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 280 MG, 1 EVERY 1 WEEK | 0 | 280 | MG | /wk | |||||||
| 114908795 | 11490879 | 4 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK | 0 | ||||||||||
| 114908795 | 11490879 | 5 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Oral | 5 MG, 1 EVERY 1 DAY | 0 | 5 | MG | QD | |||||||
| 114908795 | 11490879 | 6 | SS | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 70 G, UNK | 0 | 70 | G | ||||||||
| 114908795 | 11490879 | 7 | SS | IMMUNE GLOBULIN INTRAVENOUS (HUMAN) | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 114908795 | 11490879 | 8 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 3 MG, 1 EVERY 1 WEEK | 0 | 3 | MG | /wk | |||||||
| 114908795 | 11490879 | 9 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Unknown | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 114908795 | 11490879 | 10 | SS | KINERET | ANAKINRA | 1 | Subcutaneous | 50 MG, 1 EVERY 1 DAY | 0 | 50 | MG | QD | |||||||
| 114908795 | 11490879 | 11 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 114908795 | 11490879 | 12 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | 15 MG/M2, QWK | 0 | 15 | MG/M**2 | /wk | |||||||
| 114908795 | 11490879 | 13 | SS | ORENCIA | ABATACEPT | 1 | Intravenous (not otherwise specified) | 250 MG, QMO | 0 | 250 | MG | /month | |||||||
| 114908795 | 11490879 | 14 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 3 MG, BID | 0 | 3 | MG | BID | |||||||
| 114908795 | 11490879 | 15 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 114908795 | 11490879 | 16 | SS | ANAKINRA | ANAKINRA | 1 | Subcutaneous | 50 MG, QD | 0 | 50 | MG | QD | |||||||
| 114908795 | 11490879 | 17 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 250 MG, 1 EVERY 1 DAY | 0 | 250 | MG | QD | |||||||
| 114908795 | 11490879 | 18 | SS | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | UNK | 0 | INJECTION | |||||||||
| 114908795 | 11490879 | 19 | SS | ABATACEPT | ABATACEPT | 1 | Intravenous (not otherwise specified) | 250 MG, QMO | 0 | 250 | MG | /month | |||||||
| 114908795 | 11490879 | 20 | SS | TOCILIZUMAB | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 280 MG, Q2WK | 0 | 280 | MG | QOW | |||||||
| 114908795 | 11490879 | 21 | SS | IMMUNOGLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 0 | |||||||||||
| 114908795 | 11490879 | 22 | SS | NAPROXEN. | NAPROXEN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114908795 | 11490879 | 1 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 3 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 4 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 5 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 6 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 8 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 10 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 11 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 12 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 13 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 14 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 16 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 17 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 18 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 19 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 20 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 21 | Juvenile idiopathic arthritis |
| 114908795 | 11490879 | 22 | Juvenile idiopathic arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114908795 | 11490879 | HO |
| 114908795 | 11490879 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114908795 | 11490879 | Activities of daily living impaired | |
| 114908795 | 11490879 | Adrenal insufficiency | |
| 114908795 | 11490879 | Antibody test positive | |
| 114908795 | 11490879 | Arthritis | |
| 114908795 | 11490879 | Body height below normal | |
| 114908795 | 11490879 | Bone density decreased | |
| 114908795 | 11490879 | C-reactive protein increased | |
| 114908795 | 11490879 | Condition aggravated | |
| 114908795 | 11490879 | Diarrhoea | |
| 114908795 | 11490879 | Dizziness | |
| 114908795 | 11490879 | Drug ineffective | |
| 114908795 | 11490879 | Drug intolerance | |
| 114908795 | 11490879 | Human antichimeric antibody positive | |
| 114908795 | 11490879 | Juvenile idiopathic arthritis | |
| 114908795 | 11490879 | Mobility decreased | |
| 114908795 | 11490879 | Nausea | |
| 114908795 | 11490879 | Obesity | |
| 114908795 | 11490879 | Polyarthritis | |
| 114908795 | 11490879 | Psoriasis | |
| 114908795 | 11490879 | Red blood cell sedimentation rate increased | |
| 114908795 | 11490879 | Septic shock | |
| 114908795 | 11490879 | Synovitis | |
| 114908795 | 11490879 | Therapy non-responder | |
| 114908795 | 11490879 | Vomiting | |
| 114908795 | 11490879 | Wheelchair user |
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 |
|---|---|---|---|---|---|---|
| 114908795 | 11490879 | 1 | 200608 | 0 | ||
| 114908795 | 11490879 | 2 | 200703 | 0 | ||
| 114908795 | 11490879 | 8 | 200707 | 200803 | 0 | |
| 114908795 | 11490879 | 11 | 200804 | 200806 | 0 | |
| 114908795 | 11490879 | 16 | 200808 | 201007 | 0 | |
| 114908795 | 11490879 | 19 | 201007 | 201009 | 0 | |
| 114908795 | 11490879 | 20 | 201110 | 201203 | 0 |