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: 2025-12-25 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT04874233
Description: None
Frequency Threshold: 5
Time Frame: 61 days of dosing
Study: NCT04874233
Study Brief: Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active: HU6 450mg HU6 is active study drug 0 None 0 19 16 19 View
Placebo Comparator Non-active study drug 0 None 0 20 11 20 View
Active: HU6 150mg HU6 is active Study Drug 0 None 0 20 13 20 View
Active: HU6 300mg HU6 is active study drug 0 None 0 21 17 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (version 5.0) View
Hot Flush SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (version 5.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (version 5.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (version 5.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (version 5.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (version 5.0) View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (version 5.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (version 5.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (version 5.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (version 5.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (version 5.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (version 5.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders CTCAE (version 5.0) View
Vessel puncture site haemorrhage SYSTEMATIC_ASSESSMENT General disorders CTCAE (version 5.0) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (version 5.0) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (version 5.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (version 5.0) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (version 5.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (version 5.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (version 5.0) View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (version 5.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (version 5.0) View