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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT04519658
Description: One patient who was randomized to the 1 mg CIN-107 treatment group withdrew from the study prior to treatment with the study drug due to the physician's decision.
Frequency Threshold: 5
Time Frame: From the time of informed consent to the end of the Follow-up Period, up to 24 weeks.
Study: NCT04519658
Study Brief: A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Population 1mg The Safety Population included all patients who received at least 1 dose of any randomized study drug. 0 None 2 69 16 69 View
Safety Population 2mg The Safety Population included all patients who received at least 1 dose of any randomized study drug. 0 None 6 67 8 67 View
Safety Population Placebo The Safety Population included all patients who received at least 1 dose of any randomized study drug. 0 None 2 69 10 69 View
Safety Population 0.5mg The Safety Population included all patients who received at least 1 dose of any randomized study drug. 0 None 0 69 6 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (23.0) View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (23.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (23.0) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (23.0) View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (23.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (23.0) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (23.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (23.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (23.0) View