{"description":"Safety analysis set included all patients who received at least 1 dose of study treatment (analyzed according to actual treatment received). 1 patient randomized to T + D + SoC arm and 1 patient randomized to D + SoC arm only received SoC and were included in SoC alone arm of the safety analysis set. All-cause mortality was determined for patients in the FAS (analyzed according to randomized treatment arm, regardless of the treatment received). Results are reported for the global cohort only.","eventGroups":[{"deathsNumAffected":251,"deathsNumAtRisk":338,"description":"During chemotherapy (combination) stage:\n\nPatients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"EG000","otherNumAffected":309,"otherNumAtRisk":330,"seriousNumAffected":146,"seriousNumAtRisk":330,"title":"T + D + SoC"},{"deathsNumAffected":265,"deathsNumAtRisk":338,"description":"During chemotherapy (combination) stage:\n\nPatients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"EG001","otherNumAffected":302,"otherNumAtRisk":334,"seriousNumAffected":134,"seriousNumAtRisk":334,"title":"D + SoC"},{"deathsNumAffected":285,"deathsNumAtRisk":337,"description":"During chemotherapy (combination) stage:\n\nPatients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.","id":"EG002","otherNumAffected":301,"otherNumAtRisk":333,"seriousNumAffected":117,"seriousNumAtRisk":333,"title":"SoC Alone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":330,"numEvents":22},{"groupId":"EG001","numAffected":16,"numAtRisk":334,"numEvents":19},{"groupId":"EG002","numAffected":10,"numAtRisk":333,"numEvents":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":330,"numEvents":85},{"groupId":"EG001","numAffected":72,"numAtRisk":334,"numEvents":98},{"groupId":"EG002","numAffected":79,"numAtRisk":333,"numEvents":96}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":330,"numEvents":98},{"groupId":"EG001","numAffected":57,"numAtRisk":334,"numEvents":72},{"groupId":"EG002","numAffected":49,"numAtRisk":333,"numEvents":66}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":330,"numEvents":80},{"groupId":"EG001","numAffected":32,"numAtRisk":334,"numEvents":59},{"groupId":"EG002","numAffected":39,"numAtRisk":333,"numEvents":80}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":136,"numAtRisk":330,"numEvents":281},{"groupId":"EG001","numAffected":120,"numAtRisk":334,"numEvents":258},{"groupId":"EG002","numAffected":121,"numAtRisk":333,"numEvents":243}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":150,"numAtRisk":330,"numEvents":213},{"groupId":"EG001","numAffected":137,"numAtRisk":334,"numEvents":188},{"groupId":"EG002","numAffected":146,"numAtRisk":333,"numEvents":203}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":330,"numEvents":177},{"groupId":"EG001","numAffected":75,"numAtRisk":334,"numEvents":135},{"groupId":"EG002","numAffected":77,"numAtRisk":333,"numEvents":161}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":330,"numEvents":18},{"groupId":"EG001","numAffected":20,"numAtRisk":334,"numEvents":25},{"groupId":"EG002","numAffected":16,"numAtRisk":333,"numEvents":17}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":330,"numEvents":82},{"groupId":"EG001","numAffected":51,"numAtRisk":334,"numEvents":74},{"groupId":"EG002","numAffected":45,"numAtRisk":333,"numEvents":80}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":330,"numEvents":67},{"groupId":"EG001","numAffected":31,"numAtRisk":334,"numEvents":42},{"groupId":"EG002","numAffected":39,"numAtRisk":333,"numEvents":49}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":81,"numAtRisk":330,"numEvents":116},{"groupId":"EG001","numAffected":80,"numAtRisk":334,"numEvents":119},{"groupId":"EG002","numAffected":74,"numAtRisk":333,"numEvents":93}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":330,"numEvents":19},{"groupId":"EG001","numAffected":11,"numAtRisk":334,"numEvents":15},{"groupId":"EG002","numAffected":6,"numAtRisk":333,"numEvents":6}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":330,"numEvents":35},{"groupId":"EG001","numAffected":23,"numAtRisk":334,"numEvents":29},{"groupId":"EG002","numAffected":30,"numAtRisk":333,"numEvents":34}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":330,"numEvents":65},{"groupId":"EG001","numAffected":30,"numAtRisk":334,"numEvents":38},{"groupId":"EG002","numAffected":22,"numAtRisk":333,"numEvents":30}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":330,"numEvents":83},{"groupId":"EG001","numAffected":38,"numAtRisk":334,"numEvents":67},{"groupId":"EG002","numAffected":54,"numAtRisk":333,"numEvents":77}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":330,"numEvents":32},{"groupId":"EG001","numAffected":12,"numAtRisk":334,"numEvents":13},{"groupId":"EG002","numAffected":18,"numAtRisk":333,"numEvents":27}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":330,"numEvents":66},{"groupId":"EG001","numAffected":43,"numAtRisk":334,"numEvents":63},{"groupId":"EG002","numAffected":44,"numAtRisk":333,"numEvents":59}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":330,"numEvents":47},{"groupId":"EG001","numAffected":24,"numAtRisk":334,"numEvents":41},{"groupId":"EG002","numAffected":16,"numAtRisk":333,"numEvents":27}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":330,"numEvents":67},{"groupId":"EG001","numAffected":36,"numAtRisk":334,"numEvents":59},{"groupId":"EG002","numAffected":38,"numAtRisk":333,"numEvents":51}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":330,"numEvents":33},{"groupId":"EG001","numAffected":12,"numAtRisk":334,"numEvents":16},{"groupId":"EG002","numAffected":12,"numAtRisk":333,"numEvents":21}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":330,"numEvents":18},{"groupId":"EG001","numAffected":17,"numAtRisk":334,"numEvents":20},{"groupId":"EG002","numAffected":11,"numAtRisk":333,"numEvents":11}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":330,"numEvents":34},{"groupId":"EG001","numAffected":12,"numAtRisk":334,"numEvents":23},{"groupId":"EG002","numAffected":7,"numAtRisk":333,"numEvents":12}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":330,"numEvents":66},{"groupId":"EG001","numAffected":46,"numAtRisk":334,"numEvents":96},{"groupId":"EG002","numAffected":59,"numAtRisk":333,"numEvents":110}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":330,"numEvents":28},{"groupId":"EG001","numAffected":19,"numAtRisk":334,"numEvents":24},{"groupId":"EG002","numAffected":29,"numAtRisk":333,"numEvents":35}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":330,"numEvents":23},{"groupId":"EG001","numAffected":29,"numAtRisk":334,"numEvents":30},{"groupId":"EG002","numAffected":20,"numAtRisk":333,"numEvents":24}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":330,"numEvents":44},{"groupId":"EG001","numAffected":21,"numAtRisk":334,"numEvents":50},{"groupId":"EG002","numAffected":27,"numAtRisk":333,"numEvents":53}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":92,"numAtRisk":330,"numEvents":115},{"groupId":"EG001","numAffected":71,"numAtRisk":334,"numEvents":89},{"groupId":"EG002","numAffected":81,"numAtRisk":333,"numEvents":117}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":330,"numEvents":28},{"groupId":"EG001","numAffected":18,"numAtRisk":334,"numEvents":25},{"groupId":"EG002","numAffected":12,"numAtRisk":333,"numEvents":13}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":330,"numEvents":38},{"groupId":"EG001","numAffected":11,"numAtRisk":334,"numEvents":19},{"groupId":"EG002","numAffected":14,"numAtRisk":333,"numEvents":20}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":330,"numEvents":12},{"groupId":"EG001","numAffected":16,"numAtRisk":334,"numEvents":19},{"groupId":"EG002","numAffected":18,"numAtRisk":333,"numEvents":25}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":330,"numEvents":55},{"groupId":"EG001","numAffected":28,"numAtRisk":334,"numEvents":31},{"groupId":"EG002","numAffected":20,"numAtRisk":333,"numEvents":23}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":330,"numEvents":27},{"groupId":"EG001","numAffected":16,"numAtRisk":334,"numEvents":21},{"groupId":"EG002","numAffected":15,"numAtRisk":333,"numEvents":16}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":330,"numEvents":21},{"groupId":"EG001","numAffected":9,"numAtRisk":334,"numEvents":9},{"groupId":"EG002","numAffected":20,"numAtRisk":333,"numEvents":20}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":330,"numEvents":20},{"groupId":"EG001","numAffected":8,"numAtRisk":334,"numEvents":9},{"groupId":"EG002","numAffected":8,"numAtRisk":333,"numEvents":8}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":330,"numEvents":22},{"groupId":"EG001","numAffected":22,"numAtRisk":334,"numEvents":28},{"groupId":"EG002","numAffected":9,"numAtRisk":333,"numEvents":15}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":330,"numEvents":49},{"groupId":"EG001","numAffected":23,"numAtRisk":334,"numEvents":29},{"groupId":"EG002","numAffected":24,"numAtRisk":333,"numEvents":26}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":330,"numEvents":30},{"groupId":"EG001","numAffected":40,"numAtRisk":334,"numEvents":42},{"groupId":"EG002","numAffected":29,"numAtRisk":333,"numEvents":36}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":330,"numEvents":39},{"groupId":"EG001","numAffected":38,"numAtRisk":334,"numEvents":42},{"groupId":"EG002","numAffected":22,"numAtRisk":333,"numEvents":23}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":330,"numEvents":30},{"groupId":"EG001","numAffected":29,"numAtRisk":334,"numEvents":32},{"groupId":"EG002","numAffected":24,"numAtRisk":333,"numEvents":25}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":330,"numEvents":14},{"groupId":"EG001","numAffected":16,"numAtRisk":334,"numEvents":22},{"groupId":"EG002","numAffected":17,"numAtRisk":333,"numEvents":24}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":330,"numEvents":12},{"groupId":"EG001","numAffected":19,"numAtRisk":334,"numEvents":20},{"groupId":"EG002","numAffected":9,"numAtRisk":333,"numEvents":10}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":330,"numEvents":34},{"groupId":"EG001","numAffected":36,"numAtRisk":334,"numEvents":38},{"groupId":"EG002","numAffected":20,"numAtRisk":333,"numEvents":20}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":330,"numEvents":20},{"groupId":"EG001","numAffected":20,"numAtRisk":334,"numEvents":21},{"groupId":"EG002","numAffected":2,"numAtRisk":333,"numEvents":3}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":330,"numEvents":43},{"groupId":"EG001","numAffected":30,"numAtRisk":334,"numEvents":41},{"groupId":"EG002","numAffected":15,"numAtRisk":333,"numEvents":18}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":330,"numEvents":81},{"groupId":"EG001","numAffected":46,"numAtRisk":334,"numEvents":58},{"groupId":"EG002","numAffected":22,"numAtRisk":333,"numEvents":23}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":330,"numEvents":42},{"groupId":"EG001","numAffected":21,"numAtRisk":334,"numEvents":24},{"groupId":"EG002","numAffected":4,"numAtRisk":333,"numEvents":4}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":330,"numEvents":21},{"groupId":"EG001","numAffected":9,"numAtRisk":334,"numEvents":13},{"groupId":"EG002","numAffected":6,"numAtRisk":333,"numEvents":9}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":330,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":334,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":330,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":334,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":330,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":334,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Autoimmune pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":330,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":334,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":330,"numEvents":8},{"groupId":"EG001","numAffected":3,"numAtRisk":334,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":333,"numEvents":2}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":330,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":334,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Diverticular perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":330,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":334,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Duodenal ulcer haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":330,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":334,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":330,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":334,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":330,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":334,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":333,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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