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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT02105012
Description: The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.
Frequency Threshold: 2
Time Frame: AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.
Study: NCT02105012
Study Brief: Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BD MDI 320 µg Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg None None 0 124 7 124 View
BD MDI 160 µg Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg None None 0 132 7 132 View
BD MDI 80 µg Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg None None 2 64 1 64 View
BD MDI 40 µg Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg None None 0 63 2 63 View
Placebo MDI Placebo MDI. None None 0 127 12 127 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View