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 @ 10:50 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00758069
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00758069
Study Brief: Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sitagliptin 100 mg QD The Sitagliptin 100 mg QD group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily). None None 1 None 1 None View
Sitagliptin 50 mg BID The Sitagliptin 50 mg BID group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally twice daily (BID=twice daily). None None 2 None 1 None View
Placebo The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally. None None 0 None 2 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 8.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 8.0 View