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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT05274750
Description: All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which included all randomized participants who received at least 1 dose of study treatment excluding participants from 1 site with GCP violation. AEs were reported treatment-wise.
Frequency Threshold: 3
Time Frame: All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study intervention (Day 1) till follow up week 56.
Study: NCT05274750
Study Brief: Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Depemokimab Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52 weeks. Participants were to be maintained on their existing baseline maintenance for CRSwNP SOC treatment throughout the study. 0 None 5 143 71 143 View
Placebo Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52 weeks. Participants were to be maintained on their existing baseline maintenance for CRSwNP SOC treatment throughout the study. 0 None 6 128 72 128 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders 27.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.1 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders 27.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 27.1 View
Infective exacerbation of bronchiectasis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 27.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 27.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.1 View
Nasal polyps SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 27.1 View