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 @ 3:57 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT01316692
Description: None
Frequency Threshold: 5
Time Frame: 3 years, 10 months
Study: NCT01316692
Study Brief: Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MLN8237 Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. laboratory biomarker identification and analysis: Correlative studies biopsy: Correlative studies immunohistochemistry/tissue microarrays: Correlative studies TdT-mediated dUTP nick end labeling assay: Correlative studies mass spectrometry: Correlative studies None None 2 15 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea None Gastrointestinal disorders None View
Dehydration None Gastrointestinal disorders None View
Thromboembolic event None Vascular disorders None View
Upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
Bronchial infection None Vascular disorders None View
Anemia None Blood and lymphatic system disorders None View
Platelet count decreased None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia None Metabolism and nutrition disorders None View
Anorexia None Metabolism and nutrition disorders None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypokalemia None Metabolism and nutrition disorders None View
Mucositis oral None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Fatigue None General disorders None View
Chills None General disorders None View
Pain None General disorders None View
administration site conditions None General disorders None View
White blood cell decreased None Investigations None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Bladder infection None Infections and infestations None View
Upper respiratory infection None Infections and infestations None View
Tremor None Nervous system disorders None View
Syncope None Nervous system disorders None View
Hematuria None Renal and urinary disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Hypotension None Vascular disorders None View
Palpitations None Cardiac disorders None View
Confusion None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Hypophosphatemia None Metabolism and nutrition disorders None View
Diarrhea None Gastrointestinal disorders None View
Bloating None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Gastroesophageal reflux disease None Gastrointestinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash acneiform None Skin and subcutaneous tissue disorders None View
Fever None General disorders None View
Lymphocyte count decreased None Investigations None View
Alkaline phosphatase increased None Investigations None View
Creatinine increased None Investigations None View
Anemia None Blood and lymphatic system disorders None View
Generalized muscle weakness None Musculoskeletal and connective tissue disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Nystagmus None Nervous system disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Sneezing None Respiratory, thoracic and mediastinal disorders None View
Thromboembolic event None Vascular disorders None View