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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:00 AM
NCT ID: NCT02410902
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were recorded from the time of consent through 30-days following subject completion of or withdrawal from study, equalling a maximum of 128 days.
Study: NCT02410902
Study Brief: A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CM-AT Active substance in single unit dose powder CM-AT: Single unit dose powder of active substance, 900mg, (CM-AT) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. 0 None 0 92 79 92 View
Placebo Placebo powder of inactive substance PLACEBO: Single unit dose powder of non-active substance, 900mg, (Placebo) administered 3 times per day, one at each meal for 90 days. Participants were between 3 and 8 years old inclusive. 0 None 0 98 90 98 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18 View
Stool pH Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 18 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 18 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 18 View
Upper Respiratory Tract Infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 18 View
Stool Analysis Abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 18 View
Clostridium Test Positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 18 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 18 View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 18 View
Stool pH Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 18 View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 18 View
Seasonal Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 18 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 18 View