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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT02404792
Description: Events were described as definite, probable, or possible in relation to the exercise intervention or related to other study procedures. Participants reported any AE in real-time. Additionally, participants completed a health information sheet every 2-3 weeks where they were asked about any calls or visits to their provider, hospitalizations, or imaging.
Frequency Threshold: 3
Time Frame: Adverse data were collected up at each study visit for up to 24 weeks through completion of the exercise intervention, and for 3 days following muscle biopsy, in participants who received a biopsy following completion of the exercise intervention.
Study: NCT02404792
Study Brief: Exercise for Healthy Aging: The Impact of HIV and Aging on Physical Function and the Somatopause
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIV-uninfected Controls All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) or advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks. 0 None 0 37 9 37 View
Participants With HIV All participants were aged 50 to 75 years, sedentary (\<60 minutes of physical activity each week for 6 months preceding by self-report), had a body mass index (BMI) between 20 and 40 kg/m2, and had no contraindications to initiating an exercise regimen (e.g., severe mobility limitation, unstable angina, supplemental oxygen requirement, uncontrolled hypertension). Participants with diabetes had hemoglobin A1c of 7.5% or less; sex hormone supplementation was restricted to stable, physiologic doses for ≥3 months prior to study entry and intramuscular testosterone was excluded. PLWH were on stable ART with an undetectable HIV-1 RNA for \>2 years and a CD4 T-cell count \>200 cells/µL. At week 12, VO2 max measurements were repeated and participants were randomized to either continue moderate-intensity exercise (40-50% VO2 max and 60-70% 1-RM) advance to high-intensity (60-70% of week 13 VO2 max and \>80% 1-RM) for the remaining 12 weeks. 0 None 0 32 17 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal injury/pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hernia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizzyness or lightheadedness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain and shortness of breath NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View