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 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:26 AM
NCT ID: NCT03725033
Description: None
Frequency Threshold: 0
Time Frame: During the study - 12 weeks.
Study: NCT03725033
Study Brief: Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Subetta Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal. 0 None 0 105 15 105 View
Placebo Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal. 0 None 0 97 20 97 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in the abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Epigastric pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Acute cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rhinopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Increase of leukocytes in the urine SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increase of alanine aminotransferase levels SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increase of aspartate aminotransferase level SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increase of glycated hemoglobin level SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Increase of blood pressure SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Postprandial hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Deterioration of the condition SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Unsteadiness of gait SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Concussion of the brain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View