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 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:35 PM
NCT ID: NCT06307457
Description: Due to non-interventional nature of the study minimum criteria for reporting an adverse event could not be met, hence SAEs and other AEs were not planned to be assessed/evaluated and reported.
Frequency Threshold: 0
Time Frame: All-cause mortality: From date of metastatic breast cancer diagnosis until the end of follow-up (from 01 January 2017 and 1 February 2024, maximum up to 7.09 years). Data for non-serious adverse events and serious adverse events (SAEs) were not assessed/evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs
Study: NCT06307457
Study Brief: A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Participants with HR+/HER2 mBC who initiated treatment with palbociclib as first line in combination with AI between 01 January 2017 and 31 December 2021 was observed retrospectively for approximately 1.3 months in this study. 322 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):