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 @ 3:20 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT04529005
Description: None
Frequency Threshold: 4
Time Frame: 30 days
Study: NCT04529005
Study Brief: Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Angiotensin II (Giapreza) Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management. 0 None 0 20 1 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View