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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125825512 | 12582551 | 2 | F | 20160707 | 20160718 | 20160722 | 20160726 | EXP | PHHY2016US099061 | NOVARTIS | 7.42 | YR | F | Y | 68.50000 | KG | 20160726 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125825512 | 12582551 | 1 | PS | ACZ885 | CANAKINUMAB | 1 | Subcutaneous | 180 MG, QD | 11160 | MG | Y | 125319 | 180 | MG | POWDER FOR SOL FOR INJ | QD | |||
| 125825512 | 12582551 | 2 | SS | ACZ885 | CANAKINUMAB | 1 | Subcutaneous | 180 MG, QD | 11160 | MG | Y | 125319 | 180 | MG | POWDER FOR SOL FOR INJ | QD | |||
| 125825512 | 12582551 | 3 | SS | SANDIMMUNE NEORAL | CYCLOSPORINE | 1 | Unknown | 100 MG, QD | 16350 | MG | 0 | 100 | MG | QD | |||||
| 125825512 | 12582551 | 4 | SS | SANDIMMUNE NEORAL | CYCLOSPORINE | 1 | Unknown | 150 MG, QD | 16350 | MG | 0 | 150 | MG | QD | |||||
| 125825512 | 12582551 | 5 | SS | SANDIMMUNE NEORAL | CYCLOSPORINE | 1 | Unknown | 100 MG, UNK | 16350 | MG | 0 | 100 | MG | ||||||
| 125825512 | 12582551 | 6 | SS | SANDIMMUNE NEORAL | CYCLOSPORINE | 1 | Unknown | UNK | 16350 | MG | 0 | ||||||||
| 125825512 | 12582551 | 7 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | 500 MG, QD | 0 | 500 | MG | QD | |||||||
| 125825512 | 12582551 | 8 | SS | ACTEMRA | TOCILIZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 125825512 | 12582551 | 9 | C | HUMIRA | ADALIMUMAB | 1 | Unknown | 40 MG, QD | 320 | MG | Y | 0 | 40 | MG | QD | ||||
| 125825512 | 12582551 | 10 | C | KINERET | ANAKINRA | 1 | Unknown | 100 MG, QD | 4400 | MG | Y | 0 | 100 | MG | QD | ||||
| 125825512 | 12582551 | 11 | C | KINERET | ANAKINRA | 1 | Unknown | 100 MG, QD | 4400 | MG | Y | 0 | 100 | MG | QD | ||||
| 125825512 | 12582551 | 12 | C | VOLTAREN | DICLOFENAC SODIUM | 1 | Unknown | 100 MG, QD | 3600 | MG | Y | 0 | 100 | MG | QD | ||||
| 125825512 | 12582551 | 13 | C | RELAFEN | NABUMETONE | 1 | Unknown | 500 MG, QD | 27500 | MG | Y | 0 | 500 | MG | QD | ||||
| 125825512 | 12582551 | 14 | C | RELAFEN | NABUMETONE | 1 | Unknown | 750 MG, QD | 27500 | MG | Y | 0 | 750 | MG | QD | ||||
| 125825512 | 12582551 | 15 | C | NAPROSYN | NAPROXEN | 1 | Unknown | 500 MG, QD | 75000 | MG | U | 0 | 500 | MG | QD | ||||
| 125825512 | 12582551 | 16 | C | NAPROSYN | NAPROXEN | 1 | Unknown | 500 MG, QD | 75000 | MG | U | 0 | 500 | MG | QD | ||||
| 125825512 | 12582551 | 17 | C | NAPROSYN | NAPROXEN | 1 | Unknown | 500 MG, QD | 75000 | MG | U | 0 | 500 | MG | QD | ||||
| 125825512 | 12582551 | 18 | C | FERROUS SULFATE. | FERROUS SULFATE | 1 | Unknown | 325 MG, QD | 0 | 325 | MG | QD | |||||||
| 125825512 | 12582551 | 19 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 125825512 | 12582551 | 20 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 0 | ||||||||||||
| 125825512 | 12582551 | 21 | C | PREDNISOLONE ACETATE. | PREDNISOLONE ACETATE | 1 | Unknown | 3 DRP (PER EYE), QD | 0 | 3 | GTT | EYE DROPS | QD | ||||||
| 125825512 | 12582551 | 22 | C | MEDROL | METHYLPREDNISOLONE | 1 | Unknown | 40 MG, QD | 0 | 40 | MG | QD | |||||||
| 125825512 | 12582551 | 23 | C | MEDROL | METHYLPREDNISOLONE | 1 | Unknown | 38 MG, QD | 0 | 38 | MG | QD | |||||||
| 125825512 | 12582551 | 24 | C | MEDROL | METHYLPREDNISOLONE | 1 | Unknown | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 125825512 | 12582551 | 25 | C | ISRADIPINE. | ISRADIPINE | 1 | Unknown | 2.5 MG, UNK | U | 0 | 2.5 | MG | |||||||
| 125825512 | 12582551 | 26 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 812.5 MG, QD | 812.5 | MG | Y | 0 | 812.5 | MG | QD | ||||
| 125825512 | 12582551 | 27 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | 25 MG, QD | 25 | MG | Y | 0 | 25 | MG | QD | ||||
| 125825512 | 12582551 | 28 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, QD | 20 | MG | Y | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125825512 | 12582551 | 1 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 3 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 7 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 9 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 10 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 12 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 13 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 15 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 18 | Anaemia |
| 125825512 | 12582551 | 19 | Prophylaxis against gastrointestinal ulcer |
| 125825512 | 12582551 | 20 | Nausea |
| 125825512 | 12582551 | 21 | Uveitis |
| 125825512 | 12582551 | 22 | Juvenile idiopathic arthritis |
| 125825512 | 12582551 | 25 | Product used for unknown indication |
| 125825512 | 12582551 | 26 | Product used for unknown indication |
| 125825512 | 12582551 | 27 | Product used for unknown indication |
| 125825512 | 12582551 | 28 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125825512 | 12582551 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125825512 | 12582551 | Abdominal pain | |
| 125825512 | 12582551 | Blood glucose increased | |
| 125825512 | 12582551 | Headache | |
| 125825512 | 12582551 | Hepatomegaly | |
| 125825512 | 12582551 | Hypertension | |
| 125825512 | 12582551 | Inappropriate schedule of drug administration | |
| 125825512 | 12582551 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 125825512 | 12582551 | 1 | 20160325 | 20160413 | 0 | |
| 125825512 | 12582551 | 2 | 20160428 | 20160608 | 0 | |
| 125825512 | 12582551 | 3 | 20160113 | 20160211 | 0 | |
| 125825512 | 12582551 | 4 | 20160211 | 20160509 | 0 | |
| 125825512 | 12582551 | 5 | 20160509 | 0 | ||
| 125825512 | 12582551 | 6 | 20160706 | 0 | ||
| 125825512 | 12582551 | 7 | 20160621 | 0 | ||
| 125825512 | 12582551 | 8 | 20160706 | 0 | ||
| 125825512 | 12582551 | 9 | 20160106 | 20160113 | 0 | |
| 125825512 | 12582551 | 10 | 20160113 | 20160211 | 0 | |
| 125825512 | 12582551 | 11 | 20160211 | 20160224 | 0 | |
| 125825512 | 12582551 | 12 | 20151209 | 20160113 | 0 | |
| 125825512 | 12582551 | 13 | 20151028 | 20151118 | 0 | |
| 125825512 | 12582551 | 14 | 20151118 | 20151209 | 0 | |
| 125825512 | 12582551 | 15 | 20150901 | 20151028 | 0 | |
| 125825512 | 12582551 | 16 | 20160113 | 20160413 | 0 | |
| 125825512 | 12582551 | 17 | 20160420 | 0 | ||
| 125825512 | 12582551 | 18 | 201601 | 0 | ||
| 125825512 | 12582551 | 19 | 201509 | 0 | ||
| 125825512 | 12582551 | 21 | 201512 | 0 | ||
| 125825512 | 12582551 | 24 | 20160430 | 0 | ||
| 125825512 | 12582551 | 26 | 20160706 | 20160706 | 0 | |
| 125825512 | 12582551 | 27 | 20160706 | 20160706 | 0 | |
| 125825512 | 12582551 | 28 | 20160706 | 20160706 | 0 |