Outcomes and assessments
tumor, DLTs, neutropenia, toxicity, Malignant Lymphoma, hyperglycemia, Cancer
ADVERSE EVENT, TUMOR, NEUTROPENIA, ADVERSE DRUG REACTION, DISEASE, MALIGNANT LYMPHOMA, HYPERGLYCEMIA, PANCREATITIS, EVENTS, HYPERTENSION, CANCER
Patients were assessed for AEs, and blood samples were taken for laboratory assessments at screening, on day 1 of cycle 1, at each visit during treatment, and at the safety follow-up visit 28–35 days after the last administration of copanlisib. AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4), and assessed as related or not related to copanlisib by the investigator. Treatment-emergent AEs (TEAEs) were any AEs arising or worsening after the start of drug administration until 28–35 days after the last dose of copanlisib, and an adverse drug reaction (ADR) was an AE considered to be related to copanlisib treatment.A DLT was defined as any grade 3 or 4 non-hematologic toxicity that did not improve within 21 days despite optimal supportive care, excluding the following events: transient post-infusion grade 3 hypertension, grade 3 or 4 hyperglycemia that improves with insulin treatment, and any grade 3 or 4 lipase and/or amylase elevation without signs of pancreatitis. Hematologic DLTs were defined as grade 4 neutropenia lasting for ≥ 7 days despite adequate treatment (including granulocyte colony stimulating factor), an absolute neutrophil count < 1000/mmThe primary endpoint was to assess the safety profile of copanlisib at the recommended dose. Contrast-enhanced computed tomography or magnetic resonance imaging of all suspected disease sites was performed at screening, every 2 cycle during study treatment during Year 1, every 3 cycle during Year 2, and every 6 cycle during Year 3. An independent, blinded evaluation of the tumor status was conducted using the Revised Response Criteria for Malignant Lymphoma [