{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"14"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}]}],"title":"Any SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"15"}],"units":"Participants"}],"description":"An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.","groups":[{"description":"All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.","id":"OG000","title":"Part 2/3 (Eltrombopag Open-Label Period) Cohort 1"},{"description":"All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \\<=27 kg received 25 mg QD and participants with a body weight of \\>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.","id":"OG001","title":"Part 2/3 (Eltrombopag Open-Label Period) Cohort 2"},{"description":"All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.","id":"OG002","title":"Part 2/3 (Eltrombopag Open- Label Period) Cohort 3"}],"paramType":"NUMBER","populationDescription":"Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed","reportingStatus":"POSTED","timeFrame":"From Treatment + 1 day up to Week 31 of Part2/3","title":"Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3","type":"SECONDARY","unitOfMeasure":"Participants"}