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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT01412151
Description: Adverse events were assessed clinically (symptoms reported by the subject or signs detected on examination/through ancillary testing - vital signs, EKG, laboratory tests etc). Stable chronic conditions (e.g. diabetes, arthritis) present prior to the start of the study that did not worsen during the trial were not considered adverse events.
Frequency Threshold: 5
Time Frame: 310 Weeks
Study: NCT01412151
Study Brief: Creatine Safety & Tolerability in 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
Creatine Monohydrate Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events. None None 4 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depression with Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View