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 @ 7:18 PM
Ignite Modification Date: 2025-12-25 @ 4:57 PM
NCT ID: NCT03848403
Description: All randomized participants who received at least one dose of intervention.
Frequency Threshold: 5
Time Frame: Up to 85 Days
Study: NCT03848403
Study Brief: Study of Ixekizumab in Healthy Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ixekizumab (Reference) Reference formulation 80 mg ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods. 0 None 0 61 3 61 View
Ixekizumab (Test 1) Test 1 formulation ixekizumab 80mg administered as an SC injection in a prefilled syringe in one of three study periods. 0 None 0 63 5 63 View
Ixekizumab (Test 2) Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods. 0 None 0 61 6 61 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View