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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT02648932
Description: None
Frequency Threshold: 0
Time Frame: 100 days
Study: NCT02648932
Study Brief: The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Haplo-Cord Search If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant. Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device 1 None 0 2 1 2 View
Matched Unrelated Donor Search (MUD) If subject meets the inclusion criteria and consents, will undergo a MUD transplant. Matched Unrelated Donor Transplant 2 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View