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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT04518293
Description: The safety set included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received during the double-blind treatment period. Safety analysis was also performed for the participants who were not randomized to any of the treatment groups.
Frequency Threshold: 0.2
Time Frame: 16 weeks
Study: NCT04518293
Study Brief: Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of 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
Not Randomized Participants who were run-in failure and were not randomized (most common reason being home seated mean SBP of 120-154 mmHg in week prior to randomization visit and other reason). 0 None 15 859 136 859 View
GMRx2 Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Single pill telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg: Single pill 0 None 22 551 306 551 View
Dual - TI Telmisartan 20 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/indapamide 2.5 mg Telmisartan 20 mg/indapamide 1.25 mg: oral tablet telmisartan 40 mg/indapamide 2.5 mg: oral tablet 0 None 14 276 142 276 View
Dual - AI Amlodipine 2.5 mg/indapamide 1.25 mg. At week 6 visit, forced up-titration to amlodipine 5 mg/indapamide 2.5 mg Amlodipine 2.5 mg/indapamide 1.25 mg: oral tablet amlodipine 5 mg/indapamide 2.5 mg: oral tablet 0 None 8 276 136 276 View
Dual - TA Telmisartan 20 mg/amlodipine 2.5 mg. At week 6 visit, forced up-titration to telmisartan 40 mg/amlodipine 5 mg Telmisartan 20 mg/amlodipine 2.5 mg: oral tablet telmisartan 40 mg/amlodipine 5 mg: oral tablet 0 None 11 282 139 282 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Sialoadenitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Retroperitoneal fibrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Sleep apnoea syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Anxiety disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Lacrimal gland abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Arthritis reactive SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Cervical radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Lipids increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Glomerular filtration rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Glycosylated haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View