Adverse Events Module

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 @ 2:40 PM
Ignite Modification Date: 2025-12-25 @ 1:12 PM
NCT ID: NCT03042559
Description: None
Frequency Threshold: 0
Time Frame: The study has concluded. During the entire 4-week experiment (baseline to conclusion), no adverse event (AEs) occurred to any of the subjects. Subjects participated in one of two exercise programs over a 4 week period from baseline testing to the conclusion of the study. In each group, exercises were to be performed 3 times per week. This represents a total 12 exercise sessions (3 x 4 WEEKS ). Each session included 3 sets of 10-15 repetitions for each exercise as outlined.
Study: NCT03042559
Study Brief: Protonics Knee Brace Versus Hamstring Resisted Exercise (HRE) on Individuals With Patellofemoral Pain Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Protonics Knee Brace All subjects were fitted with a regular-sized Protonics knee brace with resistive settings to resist knee flexion. Protonics Knee brace: Protonics Therapy Program is separated into three phases for a period of 4 weeks. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks. Subjects will be monitored for any and all adverse events including excessive Delayed Onset Muscle Soreness throughout the study during the three (3) phases of the . Protonics Neuromuscular repositioning Technique training, 0 None 0 21 0 21 View
Sport Cords Resistive sports cord to resist knee flexion. Sports Cords: Sports Cord Therapy Program is separated into three phases for a period of 4 weeks. In each phase the patients will learn how to perform the sports cord gait and open-chain exercise. All subjects will be asked to perform the exercise 3 times a week, 3 sets a day; every set is 10-15 repetitions for 4 weeks.Subjects will be monitored for any and all adverse events including excessive Delayed Onset Muscle Soreness throughout the study during the three (3) phases of the Sport Cord training, 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):