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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT00433966
Description: None
Frequency Threshold: 5
Time Frame: 3 Years
Study: NCT00433966
Study Brief: Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pharmacology Arm - Bivalirudin To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in: 1. reduced rates of major bleeding events at 30 days 2. similar rates of major adverse ischemic cardiac events at 30 days 3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days. Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room). Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). 102 None 397 1800 81 1800 View
Pharmacology Arm - Unfractionated Heparin To establish the safety and efficacy of the use of bivalirudin in patients with acute myocardial infarction undergoing a primary angioplasty strategy by showing that compared to unfractionated heparin plus routine use of GP IIb/IIIa inhibitors, bivalirudin (with use of GP IIb/IIIa inhibitors reserved for angioplasty complications) results in: 1. reduced rates of major bleeding events at 30 days 2. similar rates of major adverse ischemic cardiac events at 30 days 3. reduced rates of the composite of major adverse ischemic cardiac events + major bleeding at 30 days. Bivalirudin: Bivalirudin bolus of 0.75 mg/kg IV, followed by an infusion of 1.75 mg/kg/h as soon as logistically feasible (ideally in the emergency room). Unfractionated heparin: 60 U/kg of IV heparin, started as soon as possible (ideally in the emergency room). 134 None 439 1802 132 1802 View
Stent Arm - Paclitaxel-Eluting Stent To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in: 1. reduced rates of target lesion revascularization for ischemia at 1 year 2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 3. lower rates of analysis segment binary angiographic restenosis at 13 months Bare metal stent: Uncoated bare metal stent Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent 123 None 473 2257 122 2257 View
Stent Arm - Bare Metal Stent To establish the safety and efficacy of the paclitaxel-eluting TAXUS™ stent by showing that compared to an otherwise identical bare metal EXPRESS2™ stent, the TAXUS™ stent results in: 1. reduced rates of target lesion revascularization for ischemia at 1 year 2. similar rates of death, reinfarction, stroke or stent thrombosis at 1 year 3. lower rates of analysis segment binary angiographic restenosis at 13 months Bare metal stent: Uncoated bare metal stent Paclitaxel-eluting stent: slow rate-release paclitaxel-eluting stent 48 None 185 749 32 749 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stent thrombosis (definite or probable) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death (cardiac) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ischemia-driven target vessel revascularization (TVR) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ischemia-driven target lesion revascularization (TLR) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ischemia-driven TVR, non-TLR SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Major bleeing (protocol), non-coronary artery bypass grafting-related SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blood transfusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Global Use of Strategies to Open Occluded Arteries (GUSTO) Moderate Bleeding SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombolysis in Myocardial Infarction Minor Bleeding SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Global Use of Strategies to Open Occluded Arteries Mild Bleeding SYSTEMATIC_ASSESSMENT Cardiac disorders None View