Expedited 24-hour notification followed by complete report within 5 calendar days for: All Grade 3, 4, and Grade 5 AEs Expedited 10 calendar reports for: Grade 2 AEs resulting in hospitalization or prolongation of hospitalization 2 For studies using PET or SPECT IND agents, the AE reporting period is limited to 10 radioactive half-lives, rounded UP to the nearest whole day, after the agent/intervention was last administered. above Footnote “1” applies after this reporting period. Effective Date: May 5, 2011 Additional Protocol-Specific Expedited Adverse Event Reporting Exclusions For this protocol only, the AEs/grades listed below do not require expedited reporting via AdEERS. However, they still must be reported through the routine reporting mechanism (Section 7.4): CTCAE Adverse Event Grade Hospitalization/ Attribution Comments SOC Prolongation of Hospitalization 7.4 Routine Adverse Event Reporting All Adverse Events must be reported in routine study data submissions. AEs reported through AdEERS must also be reported in routine study data submissions. 7.5 Secondary Malignancy A is a cancer caused by treatment for a previous malignancy secondary malignancy (e.g., treatment with investigational agent/intervention, radiation or chemotherapy). A secondary malignancy is not considered a metastasis of the initial neoplasm. CTEP requires all secondary malignancies that occur following treatment with an agent under an NCI IND/IDE be reported via AdEERS. Three options are available to describe the event: Leukemia secondary to oncology chemotherapy (e.g., acute myelocytic leukemia [AML]) Myelodysplastic syndrome (MDS) Treatment-related secondary malignancy Any malignancy possibly related to cancer treatment (including AML/MDS) should
Expedited 24-hour notification followed by complete report within 5 calendar days for: All Grade 3, 4, and Grade 5 AEs Expedited 10 calendar reports for: Grade 2 AEs resulting in hospitalization or prolongation of hospitalization 2 For studies using PET or SPECT IND agents, the AE reporting period is limited to 10 radioactive half-lives, rounded UP to the nearest whole day, after the agent/intervention was last administered. Footnote “1” above applies after this reporting period. Effective Date: May 5, 2011 Additional Protocol-Specific Expedited Adverse Event Reporting Exclusions For this protocol only, the AEs/grades listed below do not require expedited reporting via AdEERS. However, they still must be reported through the routine reporting mechanism (Section 7.4): CTCAE SOC Adverse Event Grade Hospitalization/ Prolongation of Hospitalization Attribution Comments 7.4 Routine Adverse Event Reporting All Adverse Events must be reported in routine study data submissions. AEs reported through AdEERS must also be reported in routine study data submissions. 7.5 Secondary Malignancy A secondary malignancy is a cancer caused by treatment for a previous malignancy (e.g., treatment with investigational agent/intervention, radiation or chemotherapy). A secondary malignancy is not considered a metastasis of the initial neoplasm. CTEP requires all secondary malignancies that occur following treatment with an agent under an NCI IND/IDE be reported via AdEERS. Three options are available to describe the event: Leukemia secondary to oncology chemotherapy (e.g., acute myelocytic leukemia [AML]) Myelodysplastic syndrome (MDS) Treatment-related secondary malignancy Any malignancy possibly related to cancer treatment (including AML/MDS) should
Hepatic_Dysfunction_Template_v4.docx