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 @ 3:38 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT02918292
Description: An AE is any undesirable sign, symptom or medical condition or experience that develops or worsens after starting the first dose of study treatment or any procedure specified in the protocol, regardless of relationship to the study. A SAE is any AE that results in one of the followings, regardless of causality and expectedness: death, life-threatening, inpatient hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event.
Frequency Threshold: 0
Time Frame: Adverse event reporting and monitoring were conducted throughout the study, up to 1 year.
Study: NCT02918292
Study Brief: Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enrolled Participants Participants will be treated with a preparative regimen of Antithymocyte Globulin (ATG) (4.5 mg/kg), fludarabine (150 mg/m\^2), cyclophosphamide (29 mg/kg), and low dose total body irradiation (TBI) (200 cGy) before undergoing the haplo HSCT. GVHD prophylaxis will be with post-HSCT cyclophosphamide (100 mg/kg), tacrolimus, and mycophenolate mofetil (MMF). G-CSF will be administered post-transplant. 7 None 1 32 0 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
INCARCERATED INGUINAL HERNIA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Other Events(If Any):