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: 2025-12-24 @ 5:46 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT02072668
Description: The safety analysis population includes all participants exposed to any study intervention evaluated in this study.
Frequency Threshold: 0
Time Frame: Data collected from date of informed consent to end of study visit, approximately 3 months
Study: NCT02072668
Study Brief: The Effect of Rivaroxaban in Sickle Cell Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rivaroxaban Participants who received Rivaroxaban 20 mg tablet in either the first or the second half of the study 0 None 1 14 8 14 View
Placebo Participants who received placebo tablet (matching Rivaroxaban 20 mg) in either the first or the second half of the study 0 None 1 13 7 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
painful crisis with bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
pain crisis treated at home SYSTEMATIC_ASSESSMENT Vascular disorders None View
chest pain SYSTEMATIC_ASSESSMENT General disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ankle laceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
tick bite SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
diarrhea, nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View
tinea versicolor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
elevate liver enzymes SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough, fever, body aches, congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pain in lower extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
dyspnea SYSTEMATIC_ASSESSMENT General disorders None View
pelvic pressure with urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
right flank pain SYSTEMATIC_ASSESSMENT General disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View