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: 2025-12-24 @ 3:21 PM
Ignite Modification Date: 2025-12-25 @ 1:40 PM
NCT ID: NCT02127892
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected over a period of 1 year post transplant.
Study: NCT02127892
Study Brief: SCID Bu/Flu/ATG Study With T Cell Depletion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Unrelated BM With T Cell Depletion Acceptable matching for matched unrelated donor (MUD) bone marrow will be genotypic matches at 10 of 10 HLA alleles (HLA-A, B, C, DR and DQ) or 9 of 10 HLA alleles. unrelated BM with T cell depletion: Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted). 1 None 1 7 5 7 View
Unrelated Cord Blood Acceptable matching for unrelated cord blood will be a genotypic match at 6 of 6 alleles (HLA A, B and DR) or 5 of 6 alleles, but not with mismatches at both alleles of a single locus (e.g. not mismatched for both HLA A alleles). unrelated cord blood: Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP. 1 None 1 2 1 2 View
Haplo BM With T Cell Depletion If there is no unrelated donor available meeting the matching criteria for unrelated bone marrow or unrelated cord blood donors. haplo BM with T cell depletion: haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation. 0 None 0 0 0 0 View
Unrelated PBSC With T Cell Depletion The preferred source will be bone marrow, however, if a donor is unable or unwilling to donate bone marrow, peripheral blood stem cells (PBSC) will be allowed. unrelated PBSC with T cell depletion: peripheral blood stem cell will be processed for CD34+ cell isolation. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinusoidal obstruction syndrome SYSTEMATIC_ASSESSMENT Hepatobiliary disorders SOS View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pulmonary Hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection - Fungal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Graft Versus Host Disease SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection - Aspergillis SYSTEMATIC_ASSESSMENT Infections and infestations None View