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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:47 AM
NCT ID: NCT05137002
Description: None
Frequency Threshold: 5
Time Frame: Part I - AEs during the 8-week treatment period Part II - AEs during the following 4-week treatment period
Study: NCT05137002
Study Brief: A Study of CIN-107 in Patients With Uncontrolled Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) 0 None 0 64 5 64 View
CIN-107 2 mg CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) or withdraw study participation depending on BP control 1 None 1 60 3 60 View
CIN-107 0.5 mg CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) 0 None 0 63 8 63 View
CIN-107 1 mg CIN-107: CIN-107 tablets by mouth once daily. Remain on background anti-hypersensitive regimen for 8 weeks (part I). After 8 weeks, patients will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks (part II) 0 None 1 62 6 62 View
Part II - CIN-107 2 mg CIN-107: (2mg) CIN-107 tablets by mouth once daily and discontinue their background anti-hypertensive agent(s) for 4 weeks (Part II). 0 None 3 213 6 213 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (24.0) View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (24.0) View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (24.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.0) View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View