Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT02757092
Description: Before discharge,If air leakage occurs before discharge, we definition it as an adverse event, because it may extend the patient's hospital stay.After discharge, home-based rehabilitation program design as a low-to-medium intensity and non-invasive .Researchers contacted patients at home every week through phone calls to monitor the occurrence of any uncomfortable reaction and post-op 2weeks,6weeks and 12weeks regular check CXR .PFT. 6min walking test and respiratory muscle power .
Frequency Threshold: 5
Time Frame: we collect 12 weeks of adverse event data
Study: NCT02757092
Study Brief: The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pulmonary Rehabilitation Group 0-2 weeks, the aerobic exercise intensity was targeted to reach 10-11 points of RPE scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day.Triflo-II was performed 8-10 times per hour. inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure. 3-6 weeks, the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min).Triflo-II was performed 8-10 times per hour, and inspiratory muscle training, with the pressure intensity adjusted to more than 5% of that in the first stage. 0 None 0 18 6 18 View
The Control Group The control group accept the pulmonary rehabilitation , breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation. 0 None 0 18 6 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Prolonged air leak (PAL) SYSTEMATIC_ASSESSMENT Surgical and medical procedures Prolonged air leak View