Created at Source Raw Value Validated value
June 25, 2024, noon usa

* new-onset malignancy requiring urgent initiation of systemic chemotherapy * active uncontrolled systemic bacterial or fungal or other viral infection * requires anticoagulation with warfarin or equivalent vitamin k antagonists (e.g., phenprocoumon) * currently receiving btk inhibitor therapy * actively receiving anti-cancer therapy (other than hormonal therapies). all anti-cancer therapy (except hormonal therapies) must be stopped at the time of screening; can be resumed as soon as ibrutinib is discontinued. significantly t cell suppressive chemotherapy (defined as requiring pjp prophylaxis per standard guidelines) is not allowed for 3 months prior to enrollment. * clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification requirement for mechanical ventilation at screening * known bleeding disorders (e.g., von willebrand's disease, platelet storage pool disorders, or hemophilia) * stroke or intracranial hemorrhage within 6 months of screening * major surgery or non-healing wound within 4 weeks of enrollment * concomitant administration of prohibited medications * known history of human immunodeficiency virus (hiv), or active hepatitis b or c infection * disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) * requires chronic treatment with strong cyp3a inhibitors

* new-onset malignancy requiring urgent initiation of systemic chemotherapy * active uncontrolled systemic bacterial or fungal or other viral infection * requires anticoagulation with warfarin or equivalent vitamin k antagonists (e.g., phenprocoumon) * currently receiving btk inhibitor therapy * actively receiving anti-cancer therapy (other than hormonal therapies). all anti-cancer therapy (except hormonal therapies) must be stopped at the time of screening; can be resumed as soon as ibrutinib is discontinued. significantly t cell suppressive chemotherapy (defined as requiring pjp prophylaxis per standard guidelines) is not allowed for 3 months prior to enrollment. * clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification requirement for mechanical ventilation at screening * known bleeding disorders (e.g., von willebrand's disease, platelet storage pool disorders, or hemophilia) * stroke or intracranial hemorrhage within 6 months of screening * major surgery or non-healing wound within 4 weeks of enrollment * concomitant administration of prohibited medications * known history of human immunodeficiency virus (hiv), or active hepatitis b or c infection * disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) * requires chronic treatment with strong cyp3a inhibitors

Sept. 14, 2021, 4:30 a.m. usa

- new-onset malignancy requiring urgent initiation of systemic chemotherapy - active uncontrolled systemic bacterial or fungal or other viral infection - requires anticoagulation with warfarin or equivalent vitamin k antagonists (e.g., phenprocoumon) - currently receiving btk inhibitor therapy - actively receiving anti-cancer therapy (other than hormonal therapies). all anti-cancer therapy (except hormonal therapies) must be stopped at the time of screening; can be resumed as soon as ibrutinib is discontinued. significantly t cell suppressive chemotherapy (defined as requiring pjp prophylaxis per standard guidelines) is not allowed for 3 months prior to enrollment. - clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification requirement for mechanical ventilation at screening - known bleeding disorders (e.g., von willebrand's disease, platelet storage pool disorders, or hemophilia) - stroke or intracranial hemorrhage within 6 months of screening - major surgery or non-healing wound within 4 weeks of enrollment - concomitant administration of prohibited medications - known history of human immunodeficiency virus (hiv), or active hepatitis b or c infection - disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) - requires chronic treatment with strong cyp3a inhibitors

- new-onset malignancy requiring urgent initiation of systemic chemotherapy - active uncontrolled systemic bacterial or fungal or other viral infection - requires anticoagulation with warfarin or equivalent vitamin k antagonists (e.g., phenprocoumon) - currently receiving btk inhibitor therapy - actively receiving anti-cancer therapy (other than hormonal therapies). all anti-cancer therapy (except hormonal therapies) must be stopped at the time of screening; can be resumed as soon as ibrutinib is discontinued. significantly t cell suppressive chemotherapy (defined as requiring pjp prophylaxis per standard guidelines) is not allowed for 3 months prior to enrollment. - clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification requirement for mechanical ventilation at screening - known bleeding disorders (e.g., von willebrand's disease, platelet storage pool disorders, or hemophilia) - stroke or intracranial hemorrhage within 6 months of screening - major surgery or non-healing wound within 4 weeks of enrollment - concomitant administration of prohibited medications - known history of human immunodeficiency virus (hiv), or active hepatitis b or c infection - disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) - requires chronic treatment with strong cyp3a inhibitors

Oct. 26, 2020, 11:31 p.m. usa

- active uncontrolled systemic bacterial or fungal infection - requires anticoagulation with warfarin or equivalent vitamin k antagonists (e.g., phenprocoumon) - currently receiving btk inhibitor therapy - actively receiving anti-cancer therapy. all anti-cancer therapy must be stopped at the time of screening - clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification requirement for mechanical ventilation at screening - known bleeding disorders (e.g., von willebrand's disease, platelet storage pool disorders, or hemophilia) - stroke or intracranial hemorrhage within 6 months of screening - major surgery or non-healing wound within 4 weeks of enrollment - concomitant administration of prohibited medications - known history of human immunodeficiency virus (hiv), or active hepatitis b or c infection - disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) - requires chronic treatment with strong cyp3a inhibitors

- active uncontrolled systemic bacterial or fungal infection - requires anticoagulation with warfarin or equivalent vitamin k antagonists (e.g., phenprocoumon) - currently receiving btk inhibitor therapy - actively receiving anti-cancer therapy. all anti-cancer therapy must be stopped at the time of screening - clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the new york heart association functional classification requirement for mechanical ventilation at screening - known bleeding disorders (e.g., von willebrand's disease, platelet storage pool disorders, or hemophilia) - stroke or intracranial hemorrhage within 6 months of screening - major surgery or non-healing wound within 4 weeks of enrollment - concomitant administration of prohibited medications - known history of human immunodeficiency virus (hiv), or active hepatitis b or c infection - disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) - requires chronic treatment with strong cyp3a inhibitors