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 @ 7:44 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT02543203
Description: According to all laboratory reports and physician review of adverse events potentially related to oil blend administration, there are no clinically significant abnormal values or adverse events. Recorded adverse events related to study treatment include minor events such as hyperactivity and intolerance to oil smell
Frequency Threshold: 5
Time Frame: Participants are systematically monitored for adverse events by study physicians (at all 10 visits). Vital signs, including resting BP, were evaluated at every visit as well.
Study: NCT02543203
Study Brief: Essential Oils for Enhancing QOL in ASD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reconnect Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the Reconnect group. 0 None 0 24 24 24 View
Coconut Oil Blend (Comparator) Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the coconut oil comparator group. 0 None 0 23 23 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
URI NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders URI View
Increased Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Irritability View
Streptococcal pharyngitis, NON_SYSTEMATIC_ASSESSMENT Infections and infestations Streptococcal pharyn View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Vomiting View
Enuresis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders Enuresis View
Environmental Allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders Allergy View
Tussis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Tussis View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations Fever View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Gastroenteritis View
Gastrointestinal upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Gastrointestinal Ups View
Increased Self Injury NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Increased Self injur View
Otitis media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Otitis media View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Rhinorrhea View
Sleep disturbance NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Sleep disturbance View
Viral exanthem NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Viral exanthem View
Increase of verbal stemming NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Verbal stemming View
Adverse reaction to noxious oil smell NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Noxious oil smell View