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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT00737633
Description: None
Frequency Threshold: 4
Time Frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Study: NCT00737633
Study Brief: Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
16-week Population subjects who were randomized to placebo in previous study None None 1 44 33 44 View
72-week Population subjects who were randomized to active during previous study None None 0 57 34 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
parasthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
back injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
chromatopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (10.0) View
nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View