{"description":"All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. 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(14.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Palmar-Plantar Erythrodysaesthesia Syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Skin Ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Pruritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 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(14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Nail Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Nail Discoloration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Rash Erythematous"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Rash Papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Skin Irritation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":34},{"groupId":"EG001","numAffected":9,"numAtRisk":14}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":34},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Mucosal Inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Non-Cardiac Chest 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(14.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":34},{"groupId":"EG001","numAffected":13,"numAtRisk":14}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":34},{"groupId":"EG001","numAffected":5,"numAtRisk":14}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":34},{"groupId":"EG001","numAffected":8,"numAtRisk":14}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34},{"groupId":"EG001","numAffected":5,"numAtRisk":14}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Dry Mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Hemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Oral Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Cheilitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Glossodynia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Haematochezia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Intestinal Obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":34},{"groupId":"EG001","numAffected":5,"numAtRisk":14}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":34},{"groupId":"EG001","numAffected":7,"numAtRisk":14}],"term":"Decreased Appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":34},{"groupId":"EG001","numAffected":9,"numAtRisk":14}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":34},{"groupId":"EG001","numAffected":4,"numAtRisk":14}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":34},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":6,"numAtRisk":14}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":3,"numAtRisk":14}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34},{"groupId":"EG001","numAffected":1,"numAtRisk":14}],"term":"Dygeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34},{"groupId":"EG001","numAffected":0,"numAtRisk":14}],"term":"Ataxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Any Relationship","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":34},{"groupId":"EG001","numAffected":2,"numAtRisk":14}],"term":"Peripheral 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