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 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT01749293
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01749293
Study Brief: Partially HLA Mismatched (Haploidentical) Allogeneic Bone Marrow Transplantation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Haploidentical Transplant All subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol\*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis. Fludarabine: Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3. Busulfan: Subjects in this trial will receive Busulfan total AUC 2400 μmol\*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3. Total Body Irradiation: Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1. Cyclophosphamide: Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant. 2 None 1 3 0 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious None Cardiac disorders None View
Other Events(If Any):