Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:45 AM
Ignite Modification Date: 2025-12-26 @ 1:25 AM
NCT ID: NCT02980133
Description: Safety analysis set included all randomized participants who received at least 1 dose of IMP.
Frequency Threshold: 5
Time Frame: Baseline up to Week 13
Study: NCT02980133
Study Brief: Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
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 MDPI Participants received matching placebo via MDPI for 12 weeks. 0 None 1 209 11 209 View
Fp MDPI 25 mcg BID Participants received 1 inhalation of 25 mcg fluticasone propionate via MDPI BID (total daily dose: 50 mcg) for 12 weeks. 0 None 2 211 8 211 View
Fp MDPI 50 mcg BID Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks. 0 None 1 208 11 208 View
FS MDPI 50/12.5 mcg BID Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks. 0 None 4 211 9 211 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Disruptive mood dysregulation disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View