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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:31 PM
NCT ID: NCT01409993
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01409993
Study Brief: Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sildenafil - Aims 1 and 2 sildenafil 25 mg p.o. tid Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test. None None 1 39 32 39 View
Placebo - Aims 1 and 2 matching placebo p.o. tid Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test. None None 0 39 25 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hypertension and bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Smell or taste abnormality SYSTEMATIC_ASSESSMENT Nervous system disorders None View
abnormal uterine bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Lightheadeness SYSTEMATIC_ASSESSMENT General disorders None View
transient numbness NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View