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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:21 PM
NCT ID: NCT00377156
Description: All patients that began treatment and were assessed at least once for adverse events are included in this analysis. Adverse Events were collected at weeks 6 and 12 after radiation treatment, and at months 6, 9, 12, 16, 24, 36, 48, and 60 after radiation treatment.
Frequency Threshold: 0
Time Frame: Up to 60 months from the start of treatment
Study: NCT00377156
Study Brief: Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (SRS) Patients undergo stereotactic radiosurgery (SRS) received 24 Gy in a single fraction if lesions were less than 2.0cm or 20 Gy if lesions were 2 to 2.9 cm in maximum diameter. 5 None 8 68 45 68 View
Arm II (SRS+WBRT) Patients randomly assigned to SRS plus WBRT received 30 GY in 12 fractions of 2.5-Gy WBRT delivered 5 days a week. Whole brain radiotherapy began within 14 days of SRS. 7 None 11 64 53 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal 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
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Encephalitis infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase 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
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition 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
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular 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
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
External ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Optic nerve disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Gait abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 9 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pancreas infection 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
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
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Coagulopathy SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Lipase increased 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
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Chest wall 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 upper limb 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
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
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache 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
Syncope 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
Confusion 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
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hiccough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pleural hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin disorder 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
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View