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: 2025-12-26 @ 10:34 AM
Ignite Modification Date: 2025-12-26 @ 10:34 AM
NCT ID: NCT04199728
Description: Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
Frequency Threshold: 5
Time Frame: 54 days
Study: NCT04199728
Study Brief: Use of a GLP-1R Agonist to Treat Opioid Use 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
Investigational Group Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen. Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer 0 None 2 12 10 12 View
Control Group Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen 0 None 1 13 8 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vasovagal syncope SYSTEMATIC_ASSESSMENT Vascular disorders None View
Overdose to illicit drug SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI/abdominal upset SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hiccups SYSTEMATIC_ASSESSMENT General disorders None View
Continuing opioid withdrawal SYSTEMATIC_ASSESSMENT General disorders None View
Light headed SYSTEMATIC_ASSESSMENT General disorders None View
Ringing sensation SYSTEMATIC_ASSESSMENT General disorders None View
Knee pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Discomfort at Dexcom sensor site SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shakiness, diaphoresis, and tremor SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Night terrors SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intrusive thoughts or images SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Bleeding under Dexcom sensor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin irritation spots SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Insect bite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View