{"description":"A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.","eventGroups":[{"deathsNumAffected":68,"deathsNumAtRisk":137,"description":"Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.","id":"EG000","otherNumAffected":135,"otherNumAtRisk":137,"seriousNumAffected":34,"seriousNumAtRisk":137,"title":"Dato DXd 6.0 mg/kg Q3W"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":137,"numEvents":24}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":137,"numEvents":16}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":137,"numEvents":12}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137,"numEvents":7}],"term":"Keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":82,"numAtRisk":137,"numEvents":117}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":137,"numEvents":89}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":137,"numEvents":47}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":137,"numEvents":41}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":137,"numEvents":19}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":137,"numEvents":40}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":137,"numEvents":35}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":137,"numEvents":17}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":137,"numEvents":13}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137,"numEvents":7}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":137,"numEvents":20}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":9}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":137,"numEvents":14}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":137,"numEvents":17}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":9}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":12}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":13}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":10}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":10}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137,"numEvents":8}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":137,"numEvents":44}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":10}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":9}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":11}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":8}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":137,"numEvents":7}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":137,"numEvents":14}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":137,"numEvents":9}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":8}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":137,"numEvents":21}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":137,"numEvents":16}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":137,"numEvents":8}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":137,"numEvents":71}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":137,"numEvents":27}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":137,"numEvents":14}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":137,"numEvents":11}],"term":"Rash maculo-papular"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":2}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Gastric perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":137,"numEvents":2}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Soft tissue swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Non-small cell lung cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Tumour associated fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Hypoxic-ischaemic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":137,"numEvents":4}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":137,"numEvents":4}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Bronchial obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Pharyngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1}],"term":"Deep vein thrombosis"}],"timeFrame":"Adverse events (AE) were collected from the date of first treatment, up to 24 months."}