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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT06149104
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were reported from first dose of study treatment until end of study treatment, up to a maximum duration of approximately 8 months.
Study: NCT06149104
Study Brief: A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sacubitril/Valsartan The starting dose of study drug was determined by the investigator in consideration of the participant´s condition. The dose level at the end of study visit of CLCZ696B2319E1 study could remain the same, or the dose level could be changed at the discretion of the investigator. 0 None 1 8 6 8 View
All Patients All Patients 0 None 1 8 6 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (27.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (27.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (27.0) View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (27.0) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (27.0) View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (27.0) View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (27.0) View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (27.0) View