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 @ 4:06 AM
Ignite Modification Date: 2025-12-26 @ 3:03 AM
NCT ID: NCT03038620
Description: Adverse events collected at each study visit. GI side effects captured and reported in summary form.
Frequency Threshold: 0
Time Frame: For the entire duration of the study: 40 weeks.
Study: NCT03038620
Study Brief: Impact of Liraglutide 3.0 on Body Fat Distribution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Liraglutide 3.0 mg Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. 0 None 0 92 53 92 View
Placebo Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. Placebo: Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day. 0 None 0 93 34 93 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI related SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory Tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injection site reaction SYSTEMATIC_ASSESSMENT Product Issues None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fever NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View