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: 2025-12-25 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT01573767
Description: On-treatment SAEs and non-serious AEs are reported for members of the ITT Population, comprised of all participants who were randomized to treatment and received at least one dose of study medication.
Frequency Threshold: 3
Time Frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 9 weeks).
Study: NCT01573767
Study Brief: Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
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 Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication. None None 0 115 10 115 View
VI 6.25 OD Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication. None None 0 114 17 114 View
VI 12.5 OD Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication. None None 0 113 12 113 View
VI 25 OD Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication. None None 1 114 11 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View