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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT01062256
Description: The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01062256
Study Brief: Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo One placebo tablet administered orally as a single dose None None 0 55 3 55 View
Buckwheat Honey 10 milliliters (mL) administered orally as a single dose None None 0 103 3 103 View
Guaifenesin One 400 milligrams (mg) immediate release tablet administered orally as a single dose None None 0 107 4 107 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.1) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.1) View
Dry throat NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.1) View
Feeling jittery NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (12.1) View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (12.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.1) View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.1) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (12.1) View