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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115157499 | 11515749 | 9 | F | 2005 | 20160712 | 20150916 | 20160725 | EXP | CA-PFIZER INC-2015293060 | PFIZER | 1.00 | YR | F | Y | 64.00000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115157499 | 11515749 | 1 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 12.5 MG, ONCE WEEKLY | N | 0 | 12.5 | MG | /wk | ||||||
| 115157499 | 11515749 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 25 MG, Q2WK | N | 0 | 25 | MG | |||||||
| 115157499 | 11515749 | 3 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | UNK | N | 11719 | SOLUTION FOR INJECTION | |||||||||
| 115157499 | 11515749 | 4 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Subcutaneous | 15 MG/M2, WEEKLY | N | 11719 | 15 | MG/M**2 | SOLUTION FOR INJECTION | /wk | |||||
| 115157499 | 11515749 | 5 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 250 MG, 1X/DAY | N | 7073 | 250 | MG | QD | ||||||
| 115157499 | 11515749 | 6 | SS | INFLIXIMAB HOSPIRA | INFLIXIMAB | 1 | Intravenous (not otherwise specified) | 3 MG, 1 EVERY 1 WEEK | N | 0 | 3 | MG/KG | /wk | ||||||
| 115157499 | 11515749 | 7 | SS | INFLIXIMAB HOSPIRA | INFLIXIMAB | 1 | 5 MG/DOSE, UNK | N | 0 | 5 | MG | ||||||||
| 115157499 | 11515749 | 8 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Oral | 5 MG/KG, DAILY | N | 0 | 5 | MG/KG | |||||||
| 115157499 | 11515749 | 9 | SS | HYDROXYCHLOROQUINE | HYDROXYCHLOROQUINE | 1 | Oral | 5 MG/KG, DAILY | N | 0 | 5 | MG/KG | |||||||
| 115157499 | 11515749 | 10 | SS | NAPROXEN. | NAPROXEN | 1 | UNK | N | 0 | ||||||||||
| 115157499 | 11515749 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, 2X/DAY | N | 0 | 5 | MG | BID | ||||||
| 115157499 | 11515749 | 12 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, 2X/DAY | N | 0 | 5 | MG | BID | ||||||
| 115157499 | 11515749 | 13 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, 2X/DAY | N | 0 | 5 | MG | BID | ||||||
| 115157499 | 11515749 | 14 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 3 MG, 2X/DAY | N | 0 | 3 | MG | BID | ||||||
| 115157499 | 11515749 | 15 | SS | ADALIMUMAB | ADALIMUMAB | 1 | Unknown | UNK | N | 0 | |||||||||
| 115157499 | 11515749 | 16 | SS | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | N | 0 | |||||||||
| 115157499 | 11515749 | 17 | SS | IMMUNOGLOBULIN /00025201/ | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 70 G, UNK | N | 0 | 70 | G | |||||||
| 115157499 | 11515749 | 18 | SS | ANAKINRA | ANAKINRA | 1 | Subcutaneous | 50 MG, DAILY | N | 0 | 50 | MG | |||||||
| 115157499 | 11515749 | 19 | SS | ABATACEPT | ABATACEPT | 1 | Intravenous (not otherwise specified) | 250 MG, MONTHLY | N | 0 | 250 | MG | /month | ||||||
| 115157499 | 11515749 | 20 | SS | TOCILIZUMAB | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 280 MG, CYCLIC (EVERY 2 WEEKS) | N | 0 | 280 | MG | |||||||
| 115157499 | 11515749 | 21 | SS | TRIAMCINOLONE HEXACETONIDE | TRIAMCINOLONE HEXACETONIDE | 1 | UNK | N | 0 | INJECTION | |||||||||
| 115157499 | 11515749 | 22 | SS | IMMUNE GLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 70 G, UNK | U | 0 | 70 | G | |||||||
| 115157499 | 11515749 | 23 | SS | IMMUNE GLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 115157499 | 11515749 | 24 | SS | ORENCIA | ABATACEPT | 1 | 250 MG, MONTHLY | U | 0 | 250 | MG | /month | |||||||
| 115157499 | 11515749 | 25 | SS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | 280 MG, 1 EVERY 1 WEEK | U | 0 | 280 | MG | /wk | ||||||
| 115157499 | 11515749 | 26 | SS | HUMIRA | ADALIMUMAB | 1 | Subcutaneous | UNK | U | 0 | |||||||||
| 115157499 | 11515749 | 27 | SS | KINERET | ANAKINRA | 1 | Subcutaneous | 50 MG, 1 EVERY 1 DAY | U | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115157499 | 11515749 | 1 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 3 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 5 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 6 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 8 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 10 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 11 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 15 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 16 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 18 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 19 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 20 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 21 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 22 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 24 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 25 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 26 | Juvenile idiopathic arthritis |
| 115157499 | 11515749 | 27 | Juvenile idiopathic arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115157499 | 11515749 | HO |
| 115157499 | 11515749 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115157499 | 11515749 | Activities of daily living impaired | |
| 115157499 | 11515749 | Adrenal insufficiency | |
| 115157499 | 11515749 | Arthritis | |
| 115157499 | 11515749 | Body height below normal | |
| 115157499 | 11515749 | Bone density decreased | |
| 115157499 | 11515749 | C-reactive protein increased | |
| 115157499 | 11515749 | Condition aggravated | |
| 115157499 | 11515749 | Diarrhoea | |
| 115157499 | 11515749 | Dizziness | |
| 115157499 | 11515749 | Drug ineffective | |
| 115157499 | 11515749 | Drug intolerance | |
| 115157499 | 11515749 | Human antichimeric antibody positive | |
| 115157499 | 11515749 | Juvenile idiopathic arthritis | |
| 115157499 | 11515749 | Mobility decreased | |
| 115157499 | 11515749 | Nausea | |
| 115157499 | 11515749 | Obesity | |
| 115157499 | 11515749 | Polyarthritis | |
| 115157499 | 11515749 | Psoriasis | |
| 115157499 | 11515749 | Red blood cell sedimentation rate increased | |
| 115157499 | 11515749 | Septic shock | |
| 115157499 | 11515749 | Synovitis | |
| 115157499 | 11515749 | Therapy non-responder | |
| 115157499 | 11515749 | Vomiting | |
| 115157499 | 11515749 | 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 |
|---|---|---|---|---|---|---|
| 115157499 | 11515749 | 1 | 200608 | 200703 | 0 | |
| 115157499 | 11515749 | 2 | 200703 | 200706 | 0 | |
| 115157499 | 11515749 | 6 | 200707 | 200711 | 0 | |
| 115157499 | 11515749 | 7 | 200711 | 200803 | 0 | |
| 115157499 | 11515749 | 9 | 20140101 | 0 | ||
| 115157499 | 11515749 | 11 | 200502 | 0 | ||
| 115157499 | 11515749 | 12 | 200510 | 201501 | 0 | |
| 115157499 | 11515749 | 13 | 2015 | 0 | ||
| 115157499 | 11515749 | 14 | 201501 | 0 | ||
| 115157499 | 11515749 | 15 | 200804 | 200806 | 0 | |
| 115157499 | 11515749 | 16 | 200806 | 200808 | 0 | |
| 115157499 | 11515749 | 17 | 201501 | 0 | ||
| 115157499 | 11515749 | 18 | 200808 | 201007 | 0 | |
| 115157499 | 11515749 | 19 | 201007 | 201009 | 0 | |
| 115157499 | 11515749 | 20 | 201110 | 201203 | 0 | |
| 115157499 | 11515749 | 21 | 201402 | 2014 | 0 |