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 @ 1:05 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT01099761
Description: None
Frequency Threshold: 5
Time Frame: 24 weeks (12 weeks treatment period + 12 weeks follow up)
Study: NCT01099761
Study Brief: Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ACE-031 0.5 mg/kg q4wk ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks. None None 0 9 3 9 View
ACE-031 1.0 mg/kg q2wk ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks. None None 0 9 6 9 View
ACE-031 ACE-03 2.5 mg/kg q4wk ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks. None None 0 0 0 0 View
Placebo Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks. None None 0 6 3 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
telangiectasia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View