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 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT03691493
Description: None
Frequency Threshold: 0
Time Frame: All-Cause Mortality monitored/assessed up to 44 months. Adverse Events were monitored/assessed up to 3 months post Radiation Therapy.
Study: NCT03691493
Study Brief: Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Grade 3 Adverse Event Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Anastrozole: Given PO Exemestane: Given PO Fulvestrant: Given IM 0 None 0 36 17 36 View
Grade 4 Adverse Event Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Anastrozole: Given PO Exemestane: Given PO Fulvestrant: Given IM 0 None 0 36 2 36 View
Grade 5 Adverse Event Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Anastrozole: Given PO Exemestane: Given PO Fulvestrant: Given IM 7 None 0 36 0 36 View
Grade 2 Adverse Event Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Anastrozole: Given PO Exemestane: Given PO Fulvestrant: Given IM 0 None 0 36 30 36 View
Grade 1 Adverse Event Patients undergo radiation therapy over 5-10 days and receive palbociclib PO QD on days 1-21. At the discretion of treating physician, patients also receive letrozole, anastrozole, exemestane, or tamoxifen PO QD on days 1-28, or fulvestrant IM on days 1 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Anastrozole: Given PO Exemestane: Given PO Fulvestrant: Given IM 0 None 0 36 31 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT General disorders None View
Bilateral Arm Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bilateral Shoulder Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Skin/Rash on Back SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT General disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastroesophagealreflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Sores SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil Count Decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pruitus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
White Blood Cell Decrease SYSTEMATIC_ASSESSMENT Investigations None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dermatitis Radiation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphocyte Count Decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Moderate erythema over sternum SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Any Grade 4 AE - excluding neutropenia and leukpenia SYSTEMATIC_ASSESSMENT Investigations None View