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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT02909959
Description: Adverse conditions were collected prior to randomization and allocation of treatment at baseline. Participants who described any of these symptoms as worsening (or becoming present) over the 16 weeks of the study were classified as having an adverse event.
Frequency Threshold: 0
Time Frame: Adverse events were assessed from baseline to week 16 (a total of 16 weeks).
Study: NCT02909959
Study Brief: Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sulforaphane Participants will take a sulforaphane supplement 3-8 tablets daily, with dose depending upon body weight. Each tablet contains 125 mg broccoli seed powder and 50 mg broccoli sprout extract, providing approximately 15 µmol sulforaphane. The weight-based dosing schedule is as follows: 3 tablets (approx. 46.5 µmol SF) if \<100 lb; 5 tablets (approx. 77.5 µmol SF) if 100-125 lb; 6 tablets (approx. 93 µmol SF) if 126-175 lb; 7 tablets (approx. 108.5 µmol SF) if 176-199 lb; 8 tablets (approx. 124 µmol SF) if ≥ 200 lb 0 None 0 24 14 24 View
Placebo Participants in this arm will take placebo tablets that are identical in shape, size, and color to the sulforaphane tablets. The number of tablets taken per day corresponds to the weight-based schedule described for the sulforaphane arm. 0 None 0 24 14 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Difficulty Falling Asleep SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Localized Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sedation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Self-injurious Behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stereotypy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stomach Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Appetite Decrease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View