Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT01399918
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT01399918
Study Brief: Everolimus and Bevacizumab in Advanced Non-Clear Cell Renal Cell Carcinoma (RCC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Everolimus and Bevacizumab This is a single-institution, single-arm phase II trial of everolimus in combination with bevacizumab in patients with advanced non-clear cell RCC, who have not received prior VEGF-.or mTOR-targeted therapy. 43 None 22 55 55 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gen disorders & admin site conditions Other, spec SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View