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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT01772368
Description: None
Frequency Threshold: 5
Time Frame: Day 1 to Day 35
Study: NCT01772368
Study Brief: Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FS MDPI 100/6.25 mcg Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate. 0 None 0 68 0 68 View
FS MDPI 100/12.5mcg Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate. 0 None 0 69 0 69 View
FS MDPI 100/25 mcg Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate. 0 None 0 67 0 67 View
FS MDPI 100/50 mcg Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. 0 None 0 68 0 68 View
Advair Diskus 100/50 mcg Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms. 0 None 0 66 0 66 View
Fp MDPI 100 mcg Subjects inhaled a single dose of 100 mcg fluticasone propionate. 0 None 0 67 0 67 View
Fp MDPI 50 mcg X 2 BID Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg. 0 None 0 72 4 72 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.1) View