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 @ 3:38 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT01614392
Description: None
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT01614392
Study Brief: Lower Extremity Muscle and Function in the Elderly: Study 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Velocity Low Force Power Training Lower extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). None None 0 25 1 25 View
Low Velocity High Force Power Training Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). None None 0 27 3 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
General SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View