Adverse Events Module

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 @ 10:23 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT01303835
Description: The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT01303835
Study Brief: Low Dose Naltrexone for Glioma Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Naltrexone Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed. None None 12 54 51 54 View
Placebo Randomized patients received placebo to be taken every night before bed. None None 17 56 54 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Encephalitis infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Pyramidal tract syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Eye disorders - Other, specify: VISUAL FIELD CUT IN BOTH LOWER QUADRANTS SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (4.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal disorders - Other, specify: CHIPPED TOOTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal disorders - Other, specify: DIVERTICULITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal disorders - Other, specify: DIVERTICULITIS BASELINE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Gastrointestinal disorders - Other, specify: GI BUG SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Ileal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Irritability SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, specify: FLU SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, specify: H-PYLORI SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, specify: LLE CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, specify: LYME'S DX SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Infections and infestations - Other, specify: SHINGLES SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Metabolism and nutrition disorders - Other, specify: PHOSPHORUS ELEVATED SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Buttock pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Musculoskeletal and connective tissue disorder - Other, specify: CRAMPS IN FEET SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Musculoskeletal and connective tissue disorder - Other, specify: CRAMPS IN LEGS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Musculoskeletal and connective tissue disorder - Other, specify: JOINT AND MUSCLE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders - Other, specify: BASELINE L HEMIPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders - Other, specify: DECREASED GRIP STRENGTH IN R HAND SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders - Other, specify: GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders - Other, specify: L HEMIPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Nervous system disorders - Other, specify: LE WEAKNESS SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Pyramidal tract syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Psychiatric disorders - Other, specify SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders - Other, specify: DERMATITIS AT WOUND SITE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Skin and subcutaneous tissue disorders-MACULAR ERRYTHEMATOUS, BACK AND ABDOMEN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View