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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT00985192
Description: Systemic adverse event assessment occurred every 14 days through investigator assessment during Treatment.
Frequency Threshold: 0
Time Frame: Adverse Event data collected continuously for subjects. Subjects evaluated every 14 days until 30 days after last drug dose. Up to 2.5 years.
Study: NCT00985192
Study Brief: Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach 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
Everolimus Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity everolimus laboratory biomarker analysis None None 24 47 47 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mucositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
ALT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI CTCAE v3 View
AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders NCI CTCAE v3 View
Bloating SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Cachexia SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Cardiac Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3 View
Cardiopulmonary Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Distension SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3 View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Dysphagia SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Edema - limb SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Halitosis SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Hemorrhage pulmonary - nose SYSTEMATIC_ASSESSMENT Surgical and medical procedures NCI CTCAE v3 View
Hemorrhage, GI - abdomen NOS SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3 View
Hot flashes SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Hypercholesteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTCAE v3 View
Infection - Kidney SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3 View
Infection - Lung SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3 View
Infection - urinary tract NOS SYSTEMATIC_ASSESSMENT Infections and infestations NCI CTCAE v3 View
Insomnia SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
LDL - elevated SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Mood alteration - anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3 View
Mood alteration - depression SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI CTCAE v3 View
Mucositis - oral cavity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI CTCAE v3 View
Muscle weakness - generalized SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Nasal/paranasal reactions SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Neuropathy-sensory SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Pain - abdomen SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - back SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - body SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - chest/thorax NOS SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - extremity-limb SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - eye SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - head SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - hip SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - NOS SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - oral cavity SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - shoulder SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Pain - Stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Pain - throat SYSTEMATIC_ASSESSMENT Nervous system disorders NCI CTCAE v3 View
Performance status decrease SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI CTCAE v3 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders NCI CTCAE v3 View
Stomatitis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders NCI CTCAE v3 View
Sweating SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders NCI CTCAE v3 View
Taste alteration SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI CTCAE v3 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTCAE v3 View
Weakness SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View
Weight loss SYSTEMATIC_ASSESSMENT General disorders NCI CTCAE v3 View