{"description":"Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study. Assessments up to 30 days after the date of last dose of study medication (for serious adverse events and unresolved study drug-related AEs) were included.","eventGroups":[{"description":"DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"75 Milligram (mg) DKN-01 Part A"},{"description":"DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"150 mg DKN-01 Part A"},{"description":"DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.","id":"EG002","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"300 mg DKN-01 Part A"},{"description":"DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"600 mg DKN-01 Part A"},{"description":"Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.","id":"EG004","otherNumAffected":16,"otherNumAtRisk":19,"seriousNumAffected":6,"seriousNumAtRisk":19,"title":"300 mg DKN-01 Part B"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3},{"groupId":"EG004","numAffected":4,"numAtRisk":19}],"term":"NAUSEA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":3,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":4,"numAtRisk":19}],"term":"FATIGUE"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3},{"groupId":"EG004","numAffected":4,"numAtRisk":19}],"term":"DECREASED APPETITE"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":6,"numAtRisk":19}],"term":"DYSPNOEA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3},{"groupId":"EG004","numAffected":2,"numAtRisk":19}],"term":"VOMITTING"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":2,"numAtRisk":19}],"term":"CONSTIPATION"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":1,"numAtRisk":19}],"term":"ASTHENIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":1,"numAtRisk":19}],"term":"DYSPHAGIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":2,"numAtRisk":19}],"term":"HYPOKALAEMIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":3,"numAtRisk":19}],"term":"PNEUMONIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3},{"groupId":"EG004","numAffected":3,"numAtRisk":19}],"term":"PRODUCTIVE COUGH"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"CARDIO-RESPIRATORY ARREST"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"ASCITES"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"NAUSEA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"VOMITING"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"ATRIAL FIBRILLATION"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"PAIN MANAGEMENT"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"PLEURAL EFFUSION"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"PNEUMONIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"PULMONARY EMBOLISM"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"RESPIRATORY FAILURE"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"SUPERIOR VENA CAVA SYNDROME"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (14.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":19,"numEvents":0}],"term":"PERICARDIAL EFFUSION"}],"timeFrame":"Entirety of the study. 1 year, 3 months."}