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 @ 3:01 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT00498433
Description: The Safety Population consisted of all patients that received at least one dose of study drug with at least one post-baseline safety assessment. In Part 1 of the study, no events were reported in period 1 when patients received placebo.
Frequency Threshold: 5
Time Frame: None
Study: NCT00498433
Study Brief: Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With 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
Part 1: Aliskiren All eligible patients received 4 week treatment of 300 mg aliskiren o.d.. None None 1 10 6 10 View
Part 1: Amlodipine All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. None None 0 10 3 10 View
Part 2: Placebo run-in Period After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase. None None 1 36 1 36 View
Part 2: Aliskiren Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks None None 0 8 2 8 View
Part 2: Amlodipine Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks None None 0 8 3 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MUSCLE HAEMORRHAGE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
MUSCLE STRAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
POST PROCEDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
ERECTILE DYSFUNCTION SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
PSORIASIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View