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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT04917757
Description: Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
Frequency Threshold: 5
Time Frame: From the date of primary diagnosis of the adrenal incidentaloma until the date of death or last follow-up (data lock December 31, 2018). Median follow-up duration was 7.0 years.
Study: NCT04917757
Study Brief: Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Adenoma With Possible Autonomous Cortisol Secretion cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L 168 None 130 1208 547 1250 View
Adenoma With Autonomous Cortisol Secretion cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L 41 None 22 225 123 232 View
Non-functioning Adenoma cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L 143 None 145 1892 724 2002 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MACE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dylipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View