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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT00434434
Description: Safety evaluable population
Frequency Threshold: 5
Time Frame: None
Study: NCT00434434
Study Brief: A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic 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
Liquid Omalizumab Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening None None 0 23 7 23 View
Lyopholized Omalizumab Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening None None 2 24 6 24 View
Placebo Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening None None 0 14 5 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion Spontaneous None Pregnancy, puerperium and perinatal conditions None View
Pyrexia None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest Discomfort None General disorders None View
Nasopharyngitis None Infections and infestations None View
Contusion None Injury, poisoning and procedural complications None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Joint Dislocation None Injury, poisoning and procedural complications None View
Concussion None Injury, poisoning and procedural complications None View
Joint Injury None Injury, poisoning and procedural complications None View
Headache None Nervous system disorders None View
Sinus Headache None Nervous system disorders None View
Middle Insomnia None Psychiatric disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Periorbital Oedema None Skin and subcutaneous tissue disorders None View
Facial Pain None General disorders None View
Upper Respiratory Tract Infection None Infections and infestations None View