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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT00553150
Description: CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until September 30, 2010. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning October 1, 2010. All appropriate treatment areas should have access to a copy of the CTCAE v4.0.
Frequency Threshold: 0
Time Frame: Adverse events were assessed weekly during Cycle 1, at the end of RT, prior to cycles 3-8, and during treatment with everolimus only until progression (Cycles ≥9). Only patients who had completed one cycle of treatment and completed an adverse event form were included in this adverse event table; Up to 5 years.
Study: NCT00553150
Study Brief: Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phase I Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1. None None 5 18 18 18 View
Phase II Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1. None None 32 101 99 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum triglycerides increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 9 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Upper aerodigestive tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Serum triglycerides increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Central nervous system necrosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Mini mental status examination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngeal examination abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View