Adverse event (AE) reporting policy for leukemia phase 2 studies
| (1) All deaths with possible, probable, or definite attribution to the study drug must have a written report submitted to the Institutional Review Board (IRB) via office of protocol research (OPR) within 24 hours (next working day) of knowledge of the event. All deaths not related to the study drug must have a written report submitted to the IRB within 5 working days. |
| (2) Unexpected life-threatening events will be reported to IRB within 5 working days of notification regardless of attribution to study drug. These events may include opportunistic infections, eg, CMV, pneumocystis, tuberculosis, or other unusual organisms or their presentations. Other unexpected life-threatening events, specifically events prompting initiation of life support and organ failure known not to be due to leukemia, will be reported. |
| Examples: |
| (a) Simple febrile neutropenia with hospitalization is not an expedited reportable event to the IRB but will be included in the annual report to the IRB, whereas febrile neutropenia complicated by Gram-negative bacteremia with shock or its complications is to be reported within 5 working days of notification. |
| (b) Thrombocytopenic epistaxis or bleeding from mucosal surfaces easily managed with platelet support is not an expedited reportable event to the IRB but will be included in the annual report to the IRB, whereas bleeding not controlled with platelet support within 48 hours of onset of the bleed, or resulting in significant clinical conditions (eg, CNS or pulmonary hemorrhage), will be reported within 5 working days of notification. |
| (3a) Prolonged myelosuppression following induction therapy defined as marrow cellularity 5% without evidence of leukemia 42 or more days from start of therapy and not due to use of additional antileukemia agents before day 42 will be reported within 30 days of notification. |
| (3b) Myelosuppression following postremission therapy will be reported if at 42 days after treatment marrow has not recovered to platelets >20 000×109/L or granulocytes > 500×109/L. Myelosuppression and associated complications are expected events during leukemia therapy. Myelosuppression and associated simple complications such as fever, infections, bleeding, and related hospitalizations will, except as noted above, not be reported as individual AEs, but will be summarized in annual report to the IRB. Extramedullary toxicities (eg, renal, pulmonary, hepatic) will be reported according to the standard MDACC adverse event reporting policy |
| (1) All deaths with possible, probable, or definite attribution to the study drug must have a written report submitted to the Institutional Review Board (IRB) via office of protocol research (OPR) within 24 hours (next working day) of knowledge of the event. All deaths not related to the study drug must have a written report submitted to the IRB within 5 working days. |
| (2) Unexpected life-threatening events will be reported to IRB within 5 working days of notification regardless of attribution to study drug. These events may include opportunistic infections, eg, CMV, pneumocystis, tuberculosis, or other unusual organisms or their presentations. Other unexpected life-threatening events, specifically events prompting initiation of life support and organ failure known not to be due to leukemia, will be reported. |
| Examples: |
| (a) Simple febrile neutropenia with hospitalization is not an expedited reportable event to the IRB but will be included in the annual report to the IRB, whereas febrile neutropenia complicated by Gram-negative bacteremia with shock or its complications is to be reported within 5 working days of notification. |
| (b) Thrombocytopenic epistaxis or bleeding from mucosal surfaces easily managed with platelet support is not an expedited reportable event to the IRB but will be included in the annual report to the IRB, whereas bleeding not controlled with platelet support within 48 hours of onset of the bleed, or resulting in significant clinical conditions (eg, CNS or pulmonary hemorrhage), will be reported within 5 working days of notification. |
| (3a) Prolonged myelosuppression following induction therapy defined as marrow cellularity 5% without evidence of leukemia 42 or more days from start of therapy and not due to use of additional antileukemia agents before day 42 will be reported within 30 days of notification. |
| (3b) Myelosuppression following postremission therapy will be reported if at 42 days after treatment marrow has not recovered to platelets >20 000×109/L or granulocytes > 500×109/L. Myelosuppression and associated complications are expected events during leukemia therapy. Myelosuppression and associated simple complications such as fever, infections, bleeding, and related hospitalizations will, except as noted above, not be reported as individual AEs, but will be summarized in annual report to the IRB. Extramedullary toxicities (eg, renal, pulmonary, hepatic) will be reported according to the standard MDACC adverse event reporting policy |