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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT01522404
Description: None
Frequency Threshold: 5
Time Frame: All Adverse events were collected from Baseline to week 58 among the participants in both groups.
Study: NCT01522404
Study Brief: Effects of Atomoxetine in Mild Cognitive Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atomoxetine Participants in this arm included all the participants that received Atomoxetine, starting with 10 mg po daily and increasing weekly by increments to a maximum of 100 mg po daily or the maximum tolerated dose. The group includes 20 participants on Atomoxetine during period 1 and 19 participants on Atomoxetine during period 2. 0 None 5 39 39 39 View
Inactive Compound Participants in this arm included all the participants from both groups that received a matching placebo that have inactive compound. 19 participants on inactive compound during period 1 and 18 participants on inactive compound during period 2. 0 None 1 37 37 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture of Right Leg/Hip (Pelvis) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysautonomia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypothermia/dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Severe Elevated Blood Pressure NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loss of Appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Suicide NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Falls NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Irritable Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injury to Head and Ear NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Body Cramps NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View