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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:44 AM
NCT ID: NCT04088760
Description: Only events that were determined to be attributable to study intervention noted after the first week were recorded and reported.
Frequency Threshold: 0
Time Frame: Adverse Events were collected for the first week of the study. Serious Adverse Events and All-Cause Mortality were collected up to 1 year.
Study: NCT04088760
Study Brief: TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TCRαβ+/CD19+ Depleted HSCT TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT): The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold. 6 None 2 15 7 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Worsening pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations CTCAE (5.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (5.0) View
Bacteremia (strep mitis) SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (5.0) View