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 @ 6:50 PM
Ignite Modification Date: 2025-12-25 @ 4:22 PM
NCT ID: NCT04458857
Description: The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Baseline up to Month 3
Study: NCT04458857
Study Brief: A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fremanezumab Dose B Participants weighing ≥threshold weight received fremanezumab SC at dose B for 3 months (Days 1, 29, and 57). 0 None 1 87 29 87 View
Placebo Participants received placebo matched to fremanezumab SC for 3 months (Days 1, 29, and 57). 0 None 3 112 26 112 View
Fremanezumab Dose A Participants weighing \<threshold weight received fremanezumab SC at dose A for 3 months (Days 1, 29, and 57). 0 None 1 36 8 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatitis infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Hemiparesis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Immune thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View