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 @ 12:14 PM
Ignite Modification Date: 2025-12-25 @ 12:01 PM
NCT ID: NCT05041361
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT05041361
Study Brief: HypErthermia as an Additional Treatment for the Biology and Experience of Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cognitive Behavioral Therapy (CBT) and 8 Sessions Whole-Body Hyperthermia (WBH) Participants received up to 8 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions. Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F. Cognitive Behavioral Therapy (CBT): Cognitive Behavioral Therapy (CBT) is a behavioral (psychotherapeutic) intervention for major depressive disorder (MDD). A highly trained masters' or PhD-level clinician administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol. 0 None 0 6 5 6 View
Cognitive Behavioral Therapy (CBT) and 4 Sessions Whole-Body Hyperthermia (WBH) Participants received up to 4 weekly whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions. Whole-Body Hyperthermia (WBH): Whole-body hyperthermia (WBH) was administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down lasted 3.5-4 hours, with active WBH lasting up to approximately 140 minutes. WBH took place in an infrared sauna dome, and the active heating phase lasted until participants achieved a core (rectal) temperature of 101.3 F. Cognitive Behavioral Therapy (CBT): Cognitive Behavioral Therapy (CBT) is a behavioral (psychotherapeutic) intervention for major depressive disorder (MDD). A highly trained masters' or PhD-level clinician administered 8 weekly CBT sessions (\~50 minutes each), following the standard cognitive behavioral therapy for depression protocol. 0 None 0 10 6 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Jitteriness SYSTEMATIC_ASSESSMENT General disorders None View
Migraine SYSTEMATIC_ASSESSMENT General disorders None View
Heat Rash SYSTEMATIC_ASSESSMENT General disorders None View
Heart Palpitations SYSTEMATIC_ASSESSMENT General disorders None View
Shin Pain SYSTEMATIC_ASSESSMENT General disorders None View
Tingling in arms and legs SYSTEMATIC_ASSESSMENT General disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loose Bowels SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nighttime overheating and body pain SYSTEMATIC_ASSESSMENT General disorders None View