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 @ 5:03 PM
Ignite Modification Date: 2025-12-24 @ 5:03 PM
NCT ID: NCT04158050
Description: Adverse events information was collected in the medical records.
Frequency Threshold: 0
Time Frame: Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3).
Study: NCT04158050
Study Brief: Comparison of Biologicals in Treatment of Severe Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anti-IL5/IL5R-therapy Group Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma 0 None 1 42 7 42 View
Anti-IgE-therapy Group Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma 0 None 0 22 4 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumopleuritis and pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatique NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rise in transaminases NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Limb or joint pain or oedema NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lip swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View