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 @ 10:42 PM
Ignite Modification Date: 2025-12-25 @ 8:13 PM
NCT ID: NCT00623935
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00623935
Study Brief: Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fludarabine Plus Busulfan Patients will receive a reduced intensity transplant regimen consisting of Fludarabine (40 mg/m2/day x 4 days) plus Busulfan (3.2 mg/m2/day x 2 days or 3.2 mg/m2/day x 4 days) Patients who receive Busulfan at 3.2mg/m2/day x 2 days, and a mismatched allograft (7/8 HLA match), will additionally receive 200 cGy of total body irradiation (TBI) pre-transplant. Patients will undergo an allogeneic stem cell transplant from related or unrelated donor. None None 21 56 16 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac ischemia/infarction None Cardiac disorders None View
Hypotension None Cardiac disorders None View
Fever None General disorders None View
Death not associated with CTCAE term None General disorders None View
Anorexia None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Hematoma None Vascular disorders None View
Febrile neutropenia None Infections and infestations None View
Blood Infection None Infections and infestations None View
Soft Tissue Infection None Infections and infestations None View
Infection - Other None Infections and infestations None View
Infection with normal ANC or Grade 1 or 2 neutrophils None Infections and infestations None View
Glucose, serum-high (hyperglycemia) None Metabolism and nutrition disorders None View
Confusion None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Mental status None Psychiatric disorders None View
Seizure None Nervous system disorders None View
Syncope (fainting) None Nervous system disorders None View
Abdomen Pain None Gastrointestinal disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Chest Wall Pain None Musculoskeletal and connective tissue disorders None View
Chest/Thorax Pain None Cardiac disorders None View
Syndromes - Other None General disorders None View
Thrombosis/embolism (vascular access-related) None Vascular disorders None View
Thrombosis/thrombus/embolism None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucositis/stomatitis None Gastrointestinal disorders None View
Infection None Infections and infestations None View
Blood Infection None Infections and infestations None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Thrombosis (vascular access related) None Vascular disorders None View
Anorexia None Gastrointestinal disorders None View