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 @ 2:07 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT04435795
Description: None
Frequency Threshold: 0
Time Frame: 29 Days
Study: NCT04435795
Study Brief: Inhaled Ciclesonide for Outpatients With COVID19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ciclesonide Inhaled and Nasal Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE 0 None 7 105 23 105 View
Placebo Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID 0 None 5 98 15 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospithalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Visit to the emergency department SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry nose, irritated nose or nosebleed SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Wheeze SYSTEMATIC_ASSESSMENT General disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Thrush SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Severe headache SYSTEMATIC_ASSESSMENT General disorders None View
Voice change SYSTEMATIC_ASSESSMENT General disorders None View
throat irritaiton SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View