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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT00806260
Description: None
Frequency Threshold: 5
Time Frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Study: NCT00806260
Study Brief: A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Period 1 Placebo None None None 0 39 5 39 View
Period 1 Alcohol None None None 0 41 22 41 View
Period 2 and 3 Placebo Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population. None None 0 42 11 42 View
Period 2 and 3 Qnexa The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population. None None 0 39 14 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.1) View
parethesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.1) View
pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.1) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.1) View
disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.1) View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.1) View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View
hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View
rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View
sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.1) View