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In general, the adverse events in pediatric patients were similar in frequency and type as those seen in adult patients. Severe adverse reactions reported in 69 JRA (juvenile idiopathic arthritis) patients ages 4 to 17 years included varicella, gastroenteritis, depression/personality disorder, cutaneousulcer, esophagitis/gastritis, group A streptococcal septic shock, Type 1 diabetes mellitus, and soft tissue and post-operative wound infection.
Forty-three of 69 (62%) children with JRA experienced an infection while receiving Enbrel during three months of study (part 1 open-label), and the frequency and severity of infections wassimilar in 58 patients completing 12 months of open-label extension therapy. The types ofinfections reported in JRA patients were generally mild and consistent with those commonly seenin outpatient pediatric populations. Two JRA patients developed varicella infection and signs andsymptoms of aseptic meningitis which resolved without sequelae.
The following adverse events were reported more commonly in 69 JRA patients receiving 3 months of Enbrel compared to the 349 adult RA patients in placebo-controlled trials. These included headache (19% of patients, 1.7 events per patient-year), nausea (9%, 1.0 events perpatient-year), abdominal pain (19%, 0.74 events per patient-year), and vomiting (13%, 0.74 eventsper patient-year).
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