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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT00720369
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00720369
Study Brief: CoQ10 in Geriatric Bipolar Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CoQ10 Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group. None None 0 11 9 11 View
Healthy Controls Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group. None None 1 8 2 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
chest pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
discomfort in MRI SYSTEMATIC_ASSESSMENT General disorders None View
flu like symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
persistence of pre-existing atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hair loss SYSTEMATIC_ASSESSMENT General disorders None View
eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
food poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View