{"eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":14,"description":"Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment.\n\nGC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.","id":"EG000","otherNumAffected":12,"otherNumAtRisk":14,"seriousNumAffected":6,"seriousNumAtRisk":14,"title":"Investigational Drug infusion-for Safety and Effectiveness"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":14,"numEvents":6}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":14,"numEvents":11}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Non-Cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hoarseness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":14,"numEvents":3}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":14,"numEvents":5}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Nasal Congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Mucosal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}]},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Dry Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pruritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Edema Limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Chest Wall Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Chest Pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}]},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v.4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Ileus"}],"timeFrame":"Adverse event data was collected from time of first administration of study product until 30 days of the last administration of study product, approximately 1 year and 5 months."}