{"description":"All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug and include AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose. All TESAE, and non-serious TEAEs for a preferred term at a frequency of \\> 5% in any treatment group during the randomized period are presented.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":71,"description":"Actual Treatment Group","id":"EG000","otherNumAffected":70,"otherNumAtRisk":71,"seriousNumAffected":10,"seriousNumAtRisk":71,"title":"Selumetinib 25 mg/m2"},{"deathsNumAffected":0,"deathsNumAtRisk":74,"description":"Actual Treatment Group","id":"EG001","otherNumAffected":54,"otherNumAtRisk":74,"seriousNumAffected":9,"seriousNumAtRisk":74,"title":"Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":71,"numEvents":33},{"groupId":"EG001","numAffected":6,"numAtRisk":74,"numEvents":7}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":71,"numEvents":14},{"groupId":"EG001","numAffected":10,"numAtRisk":74,"numEvents":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":71,"numEvents":14},{"groupId":"EG001","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":71,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":74,"numEvents":3}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":71,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":74,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":71,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":74,"numEvents":1}],"term":"Dental caries"}],"timeFrame":"All-cause mortality (death due to any cause) and Treatment emergent adverse events during randomised period, which is from the first dose of study intervention until the first date when selumetinib kit(s) are dispensed at Cycle 12 Day 28 (about 1 year), or 30 days after study intervention discontinuation, or up to one day prior to start of subsequent therapy, whichever occurs first. The medians of total treatment duration were 336 days for Selumetinib group and 335 days for Placebo group."}