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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT03369704
Description: Analysis was done in the safety set. n total 162 were randomized to IGE025 arm. 1 patient in IGE025 arm was randomized but received no study drug, so this patient was excluded from Safety set.
Frequency Threshold: 2
Time Frame: Adverse Events (AEs) were collected up to 85 days(end of the treatment epoch). Serious adverse events (SAE) were collected until 30 days after the end of the treatment epoch, up to approximately 4 months.
Study: NCT03369704
Study Brief: Study of Efficacy and Safety of Omalizumab in Severe Japanese Cedar Pollinosis Adult and Adolescent Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IGE025 Eligible patients randomized to this arm received omalizumab subcutaneously for 12 weeks 0 None 1 161 26 161 View
Placebo Placebo administered subcutaneously for 12 weeks 0 None 0 175 21 175 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Testicular neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View