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: 2025-12-25 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:25 AM
NCT ID: NCT03101020
Description: The patients were asked by the treating physiotherapist about adverse effects such as sore muscles, back pain and abdominal discomfort. The therapist took note on a blank paper corresponding to the participant identification number.
Frequency Threshold: 5
Time Frame: The adverse effects were collected before and after each session. A total of 5 weeks.
Study: NCT03101020
Study Brief: Visceral Manipulation in Patients With Chronic Low Back Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Group The participants received standard care physiotherapy plus active visceral manipulation Active Visceral Manipulation: Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodeno-jejunal valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times. Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes. 0 None 0 10 10 10 View
Control Group The participants received standard care physiotherapy plus placebo visceral manipulation Standard care physiotherapy: The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes. Placebo Visceral Manipulation: The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique 0 None 0 10 10 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle soreness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View