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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115673566 | 11567356 | 6 | F | 201203 | 20160913 | 20150929 | 20160921 | EXP | CA-ROCHE-1638076 | ROCHE | 8.00 | YR | F | Y | 64.00000 | KG | 20160921 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115673566 | 11567356 | 1 | PS | NAPROXEN. | NAPROXEN | 1 | Unknown | U | 17581 | ||||||||||
| 115673566 | 11567356 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 125276 | 280 | MG | SOLUTION FOR INFUSION | QOW | |||||||
| 115673566 | 11567356 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Subcutaneous | U | 0 | 15 | MG/M**2 | /wk | |||||||
| 115673566 | 11567356 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 | /wk | |||||||||
| 115673566 | 11567356 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 3 | MG | BID | |||||||
| 115673566 | 11567356 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | BID | |||||||
| 115673566 | 11567356 | 7 | SS | ABATACEPT | ABATACEPT | 1 | Intravenous (not otherwise specified) | THERAPY DURATION: 3 MONTHS | U | 0 | 250 | MG | INFUSION | /month | |||||
| 115673566 | 11567356 | 8 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | THERAPY DURATION: 3 MONTHS | U | 0 | |||||||||
| 115673566 | 11567356 | 9 | SS | ANAKINRA | ANAKINRA | 1 | Subcutaneous | THERAPY DURATION: 3 YEARS | U | 0 | 50 | MG | QD | ||||||
| 115673566 | 11567356 | 10 | SS | ETANERCEPT | ETANERCEPT | 1 | Subcutaneous | U | 0 | 12.5 | MG | /wk | |||||||
| 115673566 | 11567356 | 11 | SS | ETANERCEPT | ETANERCEPT | 1 | Subcutaneous | U | 0 | 25 | MG | /wk | |||||||
| 115673566 | 11567356 | 12 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 3 | MG/KG | ||||||||
| 115673566 | 11567356 | 13 | SS | INFLIXIMAB | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | U | 0 | 5 | MG | ||||||||
| 115673566 | 11567356 | 14 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | U | 0 | 250 | MG | QD | |||||||
| 115673566 | 11567356 | 15 | SS | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | U | 0 | ||||||||||
| 115673566 | 11567356 | 16 | SS | TRIAMCINOLONE | TRIAMCINOLONE | 1 | Unknown | U | 0 | ||||||||||
| 115673566 | 11567356 | 17 | SS | IVIG | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 115673566 | 11567356 | 18 | SS | IVIG | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | THERAPY DURATION: 3 MONTHS | U | 0 | 70 | G | INFUSION | ||||||
| 115673566 | 11567356 | 19 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Oral | U | 0 | 5 | MG/KG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115673566 | 11567356 | 1 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 2 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 3 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 5 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 7 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 8 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 9 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 10 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 12 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 14 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 15 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 17 | Juvenile idiopathic arthritis |
| 115673566 | 11567356 | 19 | Juvenile idiopathic arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115673566 | 11567356 | LT |
| 115673566 | 11567356 | OT |
| 115673566 | 11567356 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115673566 | 11567356 | Activities of daily living impaired | |
| 115673566 | 11567356 | Adrenal insufficiency | |
| 115673566 | 11567356 | Antibody test positive | |
| 115673566 | 11567356 | Bone density decreased | |
| 115673566 | 11567356 | C-reactive protein increased | |
| 115673566 | 11567356 | Condition aggravated | |
| 115673566 | 11567356 | Diarrhoea | |
| 115673566 | 11567356 | Dizziness | |
| 115673566 | 11567356 | Drug ineffective | |
| 115673566 | 11567356 | Drug intolerance | |
| 115673566 | 11567356 | Juvenile idiopathic arthritis | |
| 115673566 | 11567356 | Mobility decreased | |
| 115673566 | 11567356 | Nausea | |
| 115673566 | 11567356 | Obesity | |
| 115673566 | 11567356 | Polyarthritis | |
| 115673566 | 11567356 | Psoriasis | |
| 115673566 | 11567356 | Red blood cell sedimentation rate increased | |
| 115673566 | 11567356 | Septic shock | |
| 115673566 | 11567356 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 115673566 | 11567356 | 1 | 2005 | 0 | ||
| 115673566 | 11567356 | 2 | 201110 | 201203 | 0 | |
| 115673566 | 11567356 | 3 | 2005 | 2014 | 0 | |
| 115673566 | 11567356 | 4 | 2005 | 0 | ||
| 115673566 | 11567356 | 5 | 200510 | 0 | ||
| 115673566 | 11567356 | 6 | 201501 | 0 | ||
| 115673566 | 11567356 | 7 | 201007 | 201009 | 0 | |
| 115673566 | 11567356 | 8 | 200804 | 200806 | 0 | |
| 115673566 | 11567356 | 9 | 200808 | 201007 | 0 | |
| 115673566 | 11567356 | 10 | 200608 | 0 | ||
| 115673566 | 11567356 | 11 | 200703 | 200706 | 0 | |
| 115673566 | 11567356 | 12 | 200707 | 200803 | 0 | |
| 115673566 | 11567356 | 13 | 200711 | 200803 | 0 | |
| 115673566 | 11567356 | 14 | 2014 | 0 | ||
| 115673566 | 11567356 | 16 | 201402 | 2014 | 0 | |
| 115673566 | 11567356 | 17 | 200806 | 200808 | 0 | |
| 115673566 | 11567356 | 18 | 201501 | 0 | ||
| 115673566 | 11567356 | 19 | 2014 | 0 |