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: 2025-12-26 @ 10:44 PM
Ignite Modification Date: 2025-12-26 @ 10:44 PM
NCT ID: NCT04131712
Description: AEs and SAEs were collected according to the standard definitions used by clinicaltrials.gov.
Frequency Threshold: 0
Time Frame: Adverse events were monitored over the 9 day study period and for approximately 3 days post last biopsy.
Study: NCT04131712
Study Brief: Mechanisms Underlying Local and Systemic Effects of Massage
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ambulatory Control Following baseline assessments, participants will be randomized into the ambulatory group for the remainder of the study. Atrophy will not be induced and massage intervention will not be applied. Ambulatory groups will be recruited following the immobilized groups. 0 None 0 9 0 9 View
Ambulatory Massage Following baseline assessments, participants will be randomized into the ambulatory group for the remainder of the study. No atrophy induction. Four massage treatments will be applied every other day until the end of the study. Ambulatory groups will be recruited following the immobilized groups. Massage: A custom-made cyclic compressive loading (CCL) device will be used to apply a mechanical load to the left thigh of the participants. Massage application using a 35 Newton load will be applied for 15 minutes every other day over the course of 7 days for a total of four massages. 0 None 0 0 0 0 View
Immobilization Control Following baseline assessments, participants will be randomized into the unilateral lower limb suspension group undergoing atrophy for the remainder of the study. Massage intervention will not be applied. 0 None 0 16 4 16 View
Immobilization Massage Following baseline assessments, participants will be randomized into the unilateral lower limb suspension group undergoing atrophy for the remainder of the study. Four massage treatments will be applied every other day until the end of the study. Massage: A custom-made cyclic compressive loading (CCL) device will be used to apply a mechanical load to the left thigh of the participants. Massage application using a 35 Newton load will be applied for 15 minutes every other day over the course of 7 days for a total of four massages. 0 None 0 16 5 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View