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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT00888433
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00888433
Study Brief: Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1. DENERVATION Renal Denervation and maintenance of anti-hypertensive medications None None 5 52 18 52 View
2. CONTROL Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months None None 4 54 7 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Intra-Cerebral Aneurysm Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View