Serious adverse events
pleural effusion, pneumonia, MM, HGG, SAEs, pyrexia, sepsis
PULMONARY EMBOLISM, PLEURAL EFFUSION, PNEUMONIA, HEMORRHAGIC STROKE, ADVERSE EVENTS, DIVERTICULITIS, SEPSIS, ADENOCARCINOMA OF THE PANCREAS
Across all cohorts, 93 (45.1%) patients had serious adverse events (SAEs) regardless of study treatment relationship. The most frequently reported (≥5 patients) SAEs were pyrexia (SAEs (≥2 patients across all cohorts) regardless of study drug relationshipValues are number of patients, Preferred terms by MedDRA version 23.0 and CTCAE version 4.0.All treated patients (primary and expansion cohorts).MedDRA, Medical Dictionary for Regulatory Activities.Fatal SAEs were reported in nine (4.4%) patients. Fatal SAEs were seen in three (8.3%) patients in the ATC (sepsis, pneumonia, diverticulitis, pleural effusion and pulmonary embolism) cohort and three (5.5%) patients in the HCL (sepsis, pneumonia, adenocarcinoma of the pancreas and hemorrhagic stroke) cohort. In the BTC cohort, two (4.7%) patients died due to sepsis, and one patient in the HGG cohort died due to general physical health deterioration. No fatal SAEs were reported in the LGG and MM cohorts. None of these fatal SAEs was related to the study drug.