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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT04981366
Description: None
Frequency Threshold: 1
Time Frame: 16 weeks
Study: NCT04981366
Study Brief: Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN) Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation. Protein supplement: 40g of whey protein in the breakfast; 0 None 1 35 8 35 View
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA) Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo. isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast; 0 None 1 35 8 35 View
Control Group (CTRL) Patients allocated to this arm did not receive any intervention. 0 None 0 35 8 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Third-degree atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Articular pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fell during exercise training NON_SYSTEMATIC_ASSESSMENT General disorders None View
Transitory pain after muscle biopsies NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruising after muscle biopsies NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View