{"description":"The Safety population included all participants in the Enrolled population who received at least 1 dose or partial dose of the study treatments and had 1 post-dose safety observation recorded.","eventGroups":[{"deathsNumAffected":10,"deathsNumAtRisk":21,"description":"Participants received a single oral dose of 400 mg tazemetostat on Cycle 1 Day 1, BID dose of tazemetostat 400 mg on Days 3 to 14 and single dose of tazemetostat 400 mg on Day 15. A single oral dose of 200 mg itraconazole was administered daily from Day 18 to Day 20. From Days 21 to 35, they received a 400 mg BID dose of tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Itraconazole was also administered on Days 37 and 38 as a single oral 200 mg daily dose. On Cycle 1 Day 36, they received a single dose of 400 mg tazemetostat co-administered with a single dose of oral 200 mg itraconazole. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 40 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).","id":"EG000","otherNumAffected":19,"otherNumAtRisk":21,"seriousNumAffected":8,"seriousNumAtRisk":21,"title":"Part 1: Tazemetostat + Itraconazole"},{"deathsNumAffected":3,"deathsNumAtRisk":21,"description":"Participants received a single oral dose of 800 mg tazemetostat on Cycle 1 Day 1, BID dose of 800 mg of tazemetostat from Days 3 to 14 and a single oral dose of 800 mg tazemetostat on Day 15. From Days 17 to 23, they received an 800 mg BID dose of tazemetostat co-administered with a single dose of oral 600 mg rifampin. On Day 24, subjects received a single dose of 800 mg tazemetostat co-administered with a single dose of oral 600 mg rifampin. Rifampin was also administered on Cycle 1 Day 25 as a single oral 600 mg dose. Participants continued to receive tazemetostat treatment at the recommended therapeutic dose (oral 800 mg tazemetostat BID), from Day 27 (Cycle 2 Day 1) for each subsequent cycle of 28-day duration until Investigator assessed clinical progression per standard practice, unacceptable treatment related toxicity/withdrawal; survival follow-up (until death/study closure).","id":"EG001","otherNumAffected":20,"otherNumAtRisk":21,"seriousNumAffected":9,"seriousNumAtRisk":21,"title":"Part 2: Tazemetostat + Rifampin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":10},{"groupId":"EG001","numAffected":5,"numAtRisk":21,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":21,"numEvents":6}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":21,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":21,"numEvents":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":7,"numAtRisk":21,"numEvents":9}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":21,"numEvents":4}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":21,"numEvents":6},{"groupId":"EG001","numAffected":9,"numAtRisk":21,"numEvents":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":21,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":3}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":21,"numEvents":5}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":21,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":21,"numEvents":4}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":21,"numEvents":3}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":21,"numEvents":2}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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(23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":21,"numEvents":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Superior vena cava syndrome"}],"timeFrame":"Treatment-emergent adverse events and all-cause mortality were reported from the first dose of study treatment (Day 1) through 30 days after the end of study treatment (approximately 33 months)."}