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 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT01917656
Description: Safety analysis set included all randomised subjects who were exposed to the trial drug. Subjects in the safety analysis set contributed to the evaluation 'as treated'. A total of 315 randomised subjects were exposed to trial products during Ramadan (fasting), of which 152 subjects were exposed to liraglutide and 163 subjects were exposed to SU.
Frequency Threshold: 5
Time Frame: A treatment emergent AE during Ramadan (fasting) had onset on or after the individual subject's first day of Ramadan fasting, and no later than the individual subject's last day of Ramadan fasting.
Study: NCT01917656
Study Brief: Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
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 and Metformin Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. None None 2 152 8 152 View
Sulfonylurea and Metformin Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose. None None 0 163 1 163 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View