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 @ 1:06 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT01128361
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01128361
Study Brief: Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aerobic Exercise Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill. None None 0 39 13 39 View
Stretching Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention. None None 0 37 9 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac None Cardiac disorders None View
Muscle soreness or joint pain None Musculoskeletal and connective tissue disorders None View
Fall None Musculoskeletal and connective tissue disorders None View
Skin breakdown None Skin and subcutaneous tissue disorders None View