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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT04552769
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT04552769
Study Brief: Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Abemaciclib Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops Abemaciclib: 200 mg orally 7 None 6 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tracheal obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nail Discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Unilateral Leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shortness og Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pnuemonia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cyst NOS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Glucose High SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
WBC decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Foot Edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Creatinine Increased SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
BUN Increased SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ALT increased SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach irritated feeling of SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cramps of extremities SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hoarness of voice SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Swallowing difficult SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Breathing difficult SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Weight loss SYSTEMATIC_ASSESSMENT General disorders None View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased creatinine clearance SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CD4 lymphocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil count abnormal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Platelet count low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Monocyte decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
RDW Increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Glucose Increased SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Chlorides blood increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Troponin increased SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pressure Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View