{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"265"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"215"},{"groupId":"OG001","value":"209"}]}],"title":"Gastrointestinal disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"94"}]}],"title":"Diarrhoea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"84"}]}],"title":"Nausea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"53"}]}],"title":"Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"56"}]}],"title":"Stomatitis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"69"}]}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"38"}]}],"title":"Abdominal pain"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"23"}]}],"title":"Dyspepsia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"25"}]}],"title":"Abdominal pain upper"},{"categories":[{"measurements":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"188"}]}],"title":"Infections and infestations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"41"}]}],"title":"Pneumonia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"28"}]}],"title":"Sepsis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"177"},{"groupId":"OG001","value":"173"}]}],"title":"General disorders and administration site disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"109"}]}],"title":"Pyrexia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"37"}]}],"title":"Oedema peripheral"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"23"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"143"}]}],"title":"Blood and lymphatic system disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"113"}]}],"title":"Febrile neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"27"}]}],"title":"Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"title":"Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"19"}]}],"title":"Anaemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"153"}]}],"title":"Metabolism and nutrition disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"96"}]}],"title":"Hypokalaemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"36"}]}],"title":"Decreased appetite"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"}]}],"title":"Hypomagnesaemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"24"}]}],"title":"Hypophosphataemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"29"}]}],"title":"Hypocalcaemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"158"}]}],"title":"Skin and subcutaneous tissue disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"66"}]}],"title":"Rash"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"40"}]}],"title":"Pruritus"},{"categories":[{"measurements":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"105"}]}],"title":"Investigations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"27"}]}],"title":"Alanine aminotransferase increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"11"}]}],"title":"Electrocardiogram QT prolonged"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"19"}]}],"title":"Aspartate aminotransferase increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"12"}]}],"title":"Neutrophil count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"115"}]}],"title":"Respiratory, thoracic, and mediastinal disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"44"}]}],"title":"Cough"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"29"}]}],"title":"Epistaxis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"18"}]}],"title":"Oropharyngeal pain"},{"categories":[{"measurements":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"97"}]}],"title":"Nervous system disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"53"}]}],"title":"Headache"},{"categories":[{"measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"108"}]}],"title":"Musculoskeletal and connective tissue disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"35"}]}],"title":"Arthralgia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"28"}]}],"title":"Back pain"},{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"70"}]}],"title":"Vascular disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"33"}]}],"title":"Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"50"}]}],"title":"Psychiatric disorders"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"30"}]}],"title":"Insomnia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"268"}],"units":"Participants"}],"description":"A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related.","groups":[{"description":"Participants who were randomized to receive quizartinib treatment regimen.","id":"OG000","title":"Quizartinib"},{"description":"Participants who were randomized to receive placebo treatment regimen.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Treatment-emergent adverse events were assessed in the Safety Analysis Set.","reportingStatus":"POSTED","timeFrame":"Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)","title":"Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia","type":"SECONDARY","unitOfMeasure":"Participants"}