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: 2025-12-24 @ 1:17 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT02919995
Description: None
Frequency Threshold: 0
Time Frame: From informed consent through study completion, up to 52 days
Study: NCT02919995
Study Brief: A Study of RPL554 in Patients With Cystic Fibrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Higher Dose RPL554 Single dose of inhaled 6 mg RPL554 RPL554: RPL554 suspension administered using a nebuliser 0 None 0 9 6 9 View
Lower Dose RPL554 Single dose of inhaled 1.5 mg RPL554 RPL554: RPL554 suspension administered using a nebuliser 0 None 1 10 6 10 View
Placebo Inhaled placebo dose Placebo: Placebo solution administered using a nebuliser 0 None 0 10 3 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
exacerbation of cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Forced expiratory volume decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Pulmonary function test decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Drug hypersensitivity NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.1 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.1 View
Infective exacerbation of cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View