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 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT03158805
Description: None
Frequency Threshold: 5
Time Frame: Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
Study: NCT03158805
Study Brief: Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Drug Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued liraglutide stopped because of gastrointestinal issues (n=1), mood dysregulation (n=1), and suicidal ideation (n=1). No adverse event was judged to reflect an interaction between liraglutide and participants' BD medications. There were no changes in psychopathology safety scales or vital signs. No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study. 0 None 0 29 29 29 View
Placebo Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued placebo did so for mood dysregulation (n=5), gastrointestinal issues (n=4), and suicidal ideation (n=2). Two participants receiving placebo had a serious adverse event- one was medically hospitalized for a bowel obstruction presumed due to past bariatric surgery while the other was psychiatrically hospitalized for mood dysregulation-neither adverse event was attributed to study medication. There were no changes in psychopathology safety scales or vital signs . No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study. 0 None 2 31 25 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bowel obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mood dysregylation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
URI SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mood dysregulation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Injection site irritatation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View