{"description":"SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.","eventGroups":[{"description":"Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \\<27 kg: 25 mg QD, Weight \\>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \\<27 kg: 12.5 mg QD, Weight \\>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.","id":"EG000","otherNumAffected":15,"otherNumAtRisk":15,"seriousNumAffected":2,"seriousNumAtRisk":15,"title":"Part 1 (Dose-Finding Period)"},{"description":"Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.","id":"EG001","otherNumAffected":20,"otherNumAtRisk":21,"seriousNumAffected":2,"seriousNumAtRisk":21,"title":"Part 2 (Randomized Period) -Placebo"},{"description":"Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \\<27 kg received 25 mg QD, and par with a body weight of \\>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \\<27 kg received 12.5 mg QD, and with a body weight of \\>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.","id":"EG002","otherNumAffected":36,"otherNumAtRisk":44,"seriousNumAffected":4,"seriousNumAtRisk":44,"title":"Part 2 (Randomized Period) - Eltrombopag"},{"description":"Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.","id":"EG003","otherNumAffected":62,"otherNumAtRisk":65,"seriousNumAffected":8,"seriousNumAtRisk":65,"title":"Part 2/ 3 (Eltrombopag Open-Label Period)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":15},{"groupId":"EG001","numAffected":6,"numAtRisk":21},{"groupId":"EG002","numAffected":4,"numAtRisk":44},{"groupId":"EG003","numAffected":10,"numAtRisk":65}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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