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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT03924193
Description: Mortality and serious adverse events were assessed for all intervention groups but adverse events (e.g., side effects expected for the study medication, LDX) were assessed only for the medication groups (LDX and LDX+CBT).
Frequency Threshold: 5
Time Frame: Reported adverse events were only monitored and collected for those receiving pharmacologic treatment for the first month of treatment.
Study: NCT03924193
Study Brief: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lisdexamfetamine Dimesylate (LDX) Lisdexamfetamine Dimesylate: Participants randomly assigned to this arm will receive 12 weeks of LDX medication. 0 None 1 47 46 47 View
Cognitive-Behavioral Therapy Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy 0 None 0 47 0 0 View
LDX and Cognitive Behavioral Therapy Combination LDX and Cognitive-Behavioral Therapy: Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy 0 None 0 47 46 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bruxism NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Increased Energy SYSTEMATIC_ASSESSMENT General disorders None View
Feeling Jittery SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Increased Heart Rate SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Itchy Skin SYSTEMATIC_ASSESSMENT General disorders None View
Excessive Sweating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling Sensation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Racing Thoughts SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nightmare SYSTEMATIC_ASSESSMENT General disorders None View
Mouth/throat Pain SYSTEMATIC_ASSESSMENT General disorders None View
Changes to Thought Patterns SYSTEMATIC_ASSESSMENT Psychiatric disorders None View