Adverse Events Module

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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT05432167
Description: Safety population included all participants who received at least one dose of any study drug.
Frequency Threshold: 0
Time Frame: From randomization (Day 1) until the end of Follow up period (approximately 8 months)
Study: NCT05432167
Study Brief: A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CIN-107 Low Dosing Strategy Group Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks. 0 None 7 65 47 65 View
Placebo Participants received oral tablets of Placebo for 26 weeks. 0 None 2 64 35 64 View
CIN-107 High Dosing Strategy Group Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks. 0 None 5 63 52 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Eye infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Toxic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Nodal arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Lower gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Generalised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hyperuricaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Hypovolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Metabolic acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 27.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Glomerular filtration rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood potassium increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
SARS-CoV-2 test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood bicarbonate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood glucose decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Cardiac murmur NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Electrocardiogram QRS complex shortened NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Electrocardiogram QT interval abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Electrocardiogram abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Eosinophil count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Helicobacter test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Liver function test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Gangrene NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Tinea capitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Trichomoniasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Dysuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
IgA nephropathy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Urine odour abnormal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 27.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Pain in jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Arteriosclerosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 27.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Feeling cold NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Mass NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 27.0 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Left ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Hyperkeratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Ingrowing nail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Intertrigo NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 27.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 27.0 View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Ocular discomfort NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Ocular hypertension NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 27.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Malignant neoplasm of eye NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.0 View
Skin cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.0 View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 27.0 View
Vaginal haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA version 27.0 View
Hypoparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA version 27.0 View
Hepatic lesion NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 27.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 27.0 View
Blood uric acid increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Influenza A virus test positive NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 27.0 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Soft tissue infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 27.0 View
Chondrocalcinosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Flank pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 27.0 View
Overflow diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 27.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 27.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 27.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 27.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 27.0 View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 27.0 View