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: 2025-12-25 @ 2:48 AM
Ignite Modification Date: 2025-12-26 @ 1:29 AM
NCT ID: NCT05036733
Description: Non-serious adverse event information was not collected.
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT05036733
Study Brief: Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in 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
Dupilumab Dupilumab: Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits. Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints. 0 None 2 15 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia-attributed acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory difficulty requiring hospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute myeloid leukemia diagnosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):