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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT02282904
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were collected over 5 years (2015 to 2019)
Study: NCT02282904
Study Brief: Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CGD Recipient CGD patients that will undergo haplo transplantation with post-transplant cyclophosphamide as described Sirolimus: For pediatric patients: Begin sirolimus 1 mg/m2 PO q4h for 3 doses, then 1 mg/m2 once a day (QD). For adult patients, begin sirolimus 5 mg PO q4h for 3 doses, then 5 mg once a day (QD). Doses may be adjusted to maintain trough levels between 8-14 ng/ml. Recipients will take sirolimus from Day +5 to at least Day 100 (minimum). Donor peripheral blood stem cells.: Infuse donor graft. Cyclophosphamide post transplant: 50 mg/kg/d IV infused over 90 minutes. Day +3 and +4 Total body 200cGy: Day -1 Cyclophosphamide: 14.5 mg/kg IV over one hour Day -6 and -5 Fludarabine: 30 mg/m2 over 30 minutes Day -6 through Day -2 Busulfan: Busulfan 3.2 mg/kg IV once daily over 2-3 hours Day -4,-3,-2 2 None 3 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post transplant lymphoproliferative disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Severe Acute GvHD SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hemorrhagic Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild GvHD SYSTEMATIC_ASSESSMENT Immune system disorders None View