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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:10 AM
NCT ID: NCT00706134
Description: Population description of safety set.
Frequency Threshold: 5
Time Frame: End of study (week 8)
Study: NCT00706134
Study Brief: Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Aliskiren 75 mg Aliskiren 75 mg tablet taken once daily in the morning with a light meal. None None 2 191 0 191 View
Aliskiren 150 mg Aliskiren 150 mg tablet taken once daily in the morning with a light meal. None None 3 189 0 189 View
Placebo Placebo tablet taken once daily in the morning with a light meal. None None 1 186 0 186 View
Aliskiren 300 mg Aliskiren 300 mg tablet taken once daily in the morning with a light meal. None None 0 188 0 188 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):