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 @ 12:38 PM
Ignite Modification Date: 2025-12-25 @ 12:12 PM
NCT ID: NCT02151461
Description: Treatment-Energent Adverse Event (TEAE) is defined as an adverse event occurring on or after the first dose of randomized study medication, or existing prior to the time of and worsening after the time of the first dose of randomized study medication. Subjects experiencing multiple episodes of a given adverse event are counted once. This was a 28 day study and adverse event reporting went upto day 30.
Frequency Threshold: 5
Time Frame: 30 days
Study: NCT02151461
Study Brief: Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FDC125 Leucine 1100mg +Metformin 125mg 0 None 1 24 3 24 View
FDC500 Leucine 1100mg +Metformin 500mg 0 None 0 24 3 24 View
Control Day 1-14: 500mg, Day 15-28: 850mg 0 None 1 23 5 23 View
FDC250 Leucine 1100mg +Metformin 250mg 0 None 1 25 3 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lacunar Infarction SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastric Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Food SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Respiratory Disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal Distension SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Nervous Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View