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 @ 3:04 AM
Ignite Modification Date: 2025-12-26 @ 1:43 AM
NCT ID: NCT00982033
Description: None
Frequency Threshold: 0
Time Frame: 2 years, 2 months
Study: NCT00982033
Study Brief: Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo 50% of subjects participating in this trial will be randomized to placebo. placebo: placebo qd for 24 weeks. None None 4 27 13 27 View
Aliskiren 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd. aliskiren: aliskiren 300mg qd for 24 weeks. None None 0 25 6 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
dyspnea, CHF exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
leg, back and or joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
altered mental status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
root canal SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
increased blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pneumonia and or upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
abdominal pain, colitis, and or virus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ear and or eye infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
viral symdrom and or possible thrush SYSTEMATIC_ASSESSMENT Endocrine disorders None View
atrial fibrillation and or palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
numbness in left arm SYSTEMATIC_ASSESSMENT Nervous system disorders None View