Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:39 AM
Ignite Modification Date: 2025-12-26 @ 1:17 AM
NCT ID: NCT02829034
Description: None
Frequency Threshold: 0
Time Frame: 7 months including 6 months of drug treatment and 1 month post treatment
Study: NCT02829034
Study Brief: Targeting Right Ventricle in Pulmonary Hypertension Gilead
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ranolazine Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks. 0 None 3 14 11 14 View
Placebo Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks 1 None 2 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dark urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
leg weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
loss of appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hair loss NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
muscle spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
restless sleep NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dryness on CPAP NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
TENOSYNOVITIS, NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
cold NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fatique NON_SYSTEMATIC_ASSESSMENT General disorders None View
bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View