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 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT02829268
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT02829268
Study Brief: A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pediatric Pediatric patients treated with dantrolene sodium dantrolene sodium: The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period and a 4-week safety follow-up period. Study assessments include medical \& medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires. 0 None 0 8 8 8 View
Adult Adult patients treated with dantrolene sodium dantrolene sodium: The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions. There is a screening period up to 56 days, a 6-month treatment period, and a 4-week safety follow-up period. Study assessments include medical \& medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires. 0 None 0 11 11 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weakness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated Hepatic enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal upset SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypoglycemia (mild) SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hyponatremia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Knee Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tics SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Knee Effusions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hit by car SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View