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 @ 7:37 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT00955903
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00955903
Study Brief: Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Participants receive Exercise Only Intervention Exercise Only: Participants will participate in supervised exercise sessions None None 11 54 36 54 View
Weight Maintenance Participants receive Exercise Only and a Weight Maintenance Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Weight Maintenance Diet: Participants will follow a weight maintenance diet None None 12 55 40 55 View
Weight Loss Participants receive Exercise Only and Reduced Calorie Diet Interventions Exercise Only: Participants will participate in supervised exercise sessions Reduced Calorie Diet: Participants will follow a reduced calorie diet None None 8 55 36 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Joint surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary symptoms SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Heart rate and blood pressure abnormalities SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Complications related to surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Broken bone SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General, Constitutional SYSTEMATIC_ASSESSMENT General disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Muscle and bone issues SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous system SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric and mood changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View