Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:56 AM
Ignite Modification Date: 2025-12-26 @ 1:36 AM
NCT ID: NCT03272633
Description: no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I
Frequency Threshold: 5
Time Frame: Up to 8 weeks after last protocol treatment
Study: NCT03272633
Study Brief: Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies 0 None 0 0 0 0 View
Cohort II (Initial IHC Within 70 Days or After Relapse) Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies 0 None 0 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Musculoskeletal and connective tissue disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General disorders and administration site conditions SYSTEMATIC_ASSESSMENT General disorders None View
Investigations SYSTEMATIC_ASSESSMENT Investigations None View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View