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: 2025-12-26 @ 2:42 PM
Ignite Modification Date: 2025-12-26 @ 2:42 PM
NCT ID: NCT00597506
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from 26Oct2007 (date of enrollment of first subject) through 17 April2010 (30 days after the last subject completed study drug).
Study: NCT00597506
Study Brief: Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bevacizumab and Everolimus Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus None None 27 50 48 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE ver 3.0 View
Enterovesicular fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Bowel Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage, GI rectum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Abdominal abscess with anastomatic leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Shortness of breath/chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Small bowel obstruction and pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Aspiration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Disease progression/Death SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Acute Renal failure SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Alkaline phosphatase elevation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Mucositis/Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View