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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT03158532
Description: Hand isquemia
Frequency Threshold: 1.8
Time Frame: 30 days
Study: NCT03158532
Study Brief: Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nitroglycerin I /Nitroglycerin II 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. 0 None 0 510 13 510 View
Placebo I/Placebo II 0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. 0 None 0 510 6 510 View
Nitroglycerin I/Placebo II 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. 0 None 0 510 12 510 View
Placebo I /Nitroglycerin II 0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis. 0 None 0 510 6 510 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View