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 @ 9:11 PM
Ignite Modification Date: 2025-12-25 @ 7:01 PM
NCT ID: NCT03664804
Description: There was no Serious Adverse Event to be reported. Non-Serious Adverse Events at the frequency threshold of 5% cut-off are reported below. Out of 95 recruited participants, 2 were withdrawn before the study intervention, therefore exluded.
Frequency Threshold: 5
Time Frame: AE timeframe: From Baseline to 15 Months
Study: NCT03664804
Study Brief: Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NHS Participants With Early Manifest Stage I or II HD Participants with Early Manifest Stage I or II HD 29 None 0 93 29 93 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post lumbar puncture syndrome NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra v 26 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Medra v 26 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Medra v 26 View
Puncture site pain NON_SYSTEMATIC_ASSESSMENT General disorders Medra v 26 View