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 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT02064205
Description: None
Frequency Threshold: 0
Time Frame: During the conduct of the study; June - November 2014
Study: NCT02064205
Study Brief: Appetite Suppression Trial With Polydextrose
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Condition A Breakfast with preload of yogurt and polydextrose None None 0 32 5 32 View
Condition B Breakfast with preload of yogurt and glucose control None None 0 32 5 32 View
Condition C Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose None None 0 31 2 31 View
Condition D Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup None None 0 32 2 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Presyncope (light headedness) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Pyrexia (fever) SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Dysmenorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (10.0) View