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 @ 1:03 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT02248961
Description: The number and percent of subjects and number and group of AEs will be performed within every organ/system group
Frequency Threshold: 0
Time Frame: 18 weeks
Study: NCT02248961
Study Brief: Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial 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
Kanarb (Fimasartan) 60/120 mg Kanarb (Fimasartan) administered orally once a day in the morning for 12 weeks period 0 None 0 89 20 89 View
Cozaar® (Losartan) 50/100 mg Cozaar® (Losartan) administered orally once a day for 12 week period 0 None 0 90 15 90 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypochromic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.1) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.1) View
Conjunctival oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.1) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (16.1) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (16.1) View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (16.1) View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (16.1) View
Irritable bowel syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.1) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.1) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.1) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.1) View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (16.1) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (16.1) View