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 @ 10:14 PM

Ignite Modification Date: 2025-12-25 @ 7:49 PM

NCT ID: NCT00085735

Description: All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.

Frequency Threshold: 0

Time Frame: None

Study: NCT00085735

Study Brief: Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

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 (3-7 Years of Age, LDCSI, IFRT)	See Detailed Description (Arm I) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV	None	None	7	63	60	63	View
Arm II (3-7 Years of Age, LDCSI, PFRT)	See Detailed Description (Arm II) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV	None	None	7	64	61	64	View
Arm III (3-7 Years of Age, SDCSI, IFRT)	See Detailed Description (Arm III) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV	None	None	6	60	55	60	View
Arm IV (3-7 Years of Age, SDCSI, PFRT)	See Detailed Description (Arm IV) Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV	None	None	3	58	53	58	View
Arm V (8-21 Years of Age, SDCSI, IFRT)	See Detailed Description (Arm V) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV	None	None	16	130	123	130	View
Arm VI (8-21 Years of Age, SDCSI, PFRT)	See Detailed Description (Arm VI) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV	None	None	18	138	135	138	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anemia	None	Blood and lymphatic system disorders	None	View
Blood and lymphatic system disorders - Other, specify	None	Blood and lymphatic system disorders	None	View
Febrile neutropenia	None	Blood and lymphatic system disorders	None	View
Esophagitis	None	Gastrointestinal disorders	None	View
Ileus	None	Gastrointestinal disorders	None	View
Encephalomyelitis infection	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Blood bilirubin increased	None	Investigations	None	View
Lymphocyte count decreased	None	Investigations	None	View
Neutrophil count decreased	None	Investigations	None	View
Platelet count decreased	None	Investigations	None	View
Weight loss	None	Investigations	None	View
White blood cell decreased	None	Investigations	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Hypermagnesemia	None	Metabolism and nutrition disorders	None	View
Hypocalcemia	None	Metabolism and nutrition disorders	None	View
Hypokalemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesemia	None	Metabolism and nutrition disorders	None	View
Generalized muscle weakness	None	Musculoskeletal and connective tissue disorders	None	View
Myelodysplastic syndrome	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Ataxia	None	Nervous system disorders	None	View
Central nervous system necrosis	None	Nervous system disorders	None	View
Cognitive disturbance	None	Nervous system disorders	None	View
Depressed level of consciousness	None	Nervous system disorders	None	View
Memory impairment	None	Nervous system disorders	None	View
Myelitis	None	Nervous system disorders	None	View
Neuralgia	None	Nervous system disorders	None	View
Peripheral motor neuropathy	None	Nervous system disorders	None	View
Peripheral sensory neuropathy	None	Nervous system disorders	None	View
Seizure	None	Nervous system disorders	None	View
Psychiatric disorders - Other, specify	None	Psychiatric disorders	None	View
Adult respiratory distress syndrome	None	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Alopecia	None	Skin and subcutaneous tissue disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Appendicitis perforated	None	Infections and infestations	None	View
Bladder infection	None	Infections and infestations	None	View
Bronchial infection	None	Infections and infestations	None	View
Catheter related infection	None	Infections and infestations	None	View
Conjunctivitis infective	None	Infections and infestations	None	View
Device related infection	None	Infections and infestations	None	View
Encephalomyelitis infection	None	Infections and infestations	None	View
Enterocolitis infectious	None	Infections and infestations	None	View
Esophageal infection	None	Infections and infestations	None	View
Eye infection	None	Infections and infestations	None	View
Gallbladder infection	None	Infections and infestations	None	View
Gum infection	None	Infections and infestations	None	View
Wound infection	None	Infections and infestations	None	View
Aortic injury	None	Injury, poisoning and procedural complications	None	View
Bruising	None	Injury, poisoning and procedural complications	None	View
Burn	None	Injury, poisoning and procedural complications	None	View
Dermatitis radiation	None	Injury, poisoning and procedural complications	None	View
Fracture	None	Injury, poisoning and procedural complications	None	View
Neck pain	None	Musculoskeletal and connective tissue disorders	None	View
Osteoporosis	None	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Abducens nerve disorder	None	Nervous system disorders	None	View
Acoustic nerve disorder NOS	None	Nervous system disorders	None	View
Ataxia	None	Nervous system disorders	None	View
Brachial plexopathy	None	Nervous system disorders	None	View
Central nervous system necrosis	None	Nervous system disorders	None	View
Cerebrospinal fluid leakage	None	Nervous system disorders	None	View
Cognitive disturbance	None	Nervous system disorders	None	View
Depressed level of consciousness	None	Nervous system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Dysarthria	None	Nervous system disorders	None	View
Dysgeusia	None	Nervous system disorders	None	View
Dysphasia	None	Nervous system disorders	None	View
Encephalopathy	None	Nervous system disorders	None	View
Glossopharyngeal nerve disorder	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Hydrocephalus	None	Nervous system disorders	None	View
Hypoglossal nerve disorder	None	Nervous system disorders	None	View
Memory impairment	None	Nervous system disorders	None	View
Nervous system disorders - Other, specify	None	Nervous system disorders	None	View
Neuralgia	None	Nervous system disorders	None	View
Nystagmus	None	Nervous system disorders	None	View
Oculomotor nerve disorder	None	Nervous system disorders	None	View
Peripheral motor neuropathy	None	Nervous system disorders	None	View
Peripheral sensory neuropathy	None	Nervous system disorders	None	View
Pyramidal tract syndrome	None	Nervous system disorders	None	View
Irregular menstruation	None	Reproductive system and breast disorders	None	View
Allergic rhinitis	None	Respiratory, thoracic and mediastinal disorders	None	View
Aspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
Atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
Bronchospasm	None	Respiratory, thoracic and mediastinal disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
Laryngeal mucositis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngeal mucositis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngolaryngeal pain	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonitis	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Anemia	None	Blood and lymphatic system disorders	None	View
Blood and lymphatic system disorders - Other, specify	None	Blood and lymphatic system disorders	None	View
Disseminated intravascular coagulation	None	Blood and lymphatic system disorders	None	View
Febrile neutropenia	None	Blood and lymphatic system disorders	None	View
Leukocytosis	None	Blood and lymphatic system disorders	None	View
Cardiac arrest	None	Cardiac disorders	None	View
Cardiac disorders - Other, specify	None	Cardiac disorders	None	View
Palpitations	None	Cardiac disorders	None	View
Sinus tachycardia	None	Cardiac disorders	None	View
Ventricular tachycardia	None	Cardiac disorders	None	View
Ear and labyrinth disorders - Other, specify	None	Ear and labyrinth disorders	None	View
Ear pain	None	Ear and labyrinth disorders	None	View
External ear inflammation	None	Ear and labyrinth disorders	None	View
External ear pain	None	Ear and labyrinth disorders	None	View
Hearing impaired	None	Ear and labyrinth disorders	None	View
Middle ear inflammation	None	Ear and labyrinth disorders	None	View
Tinnitus	None	Ear and labyrinth disorders	None	View
Gingival pain	None	Gastrointestinal disorders	None	View
Ileus	None	Gastrointestinal disorders	None	View
Mucositis oral	None	Gastrointestinal disorders	None	View
Infections and infestations - Other, specify	None	Infections and infestations	None	View
Laryngitis	None	Infections and infestations	None	View
Lip infection	None	Infections and infestations	None	View
Lung infection	None	Infections and infestations	None	View
Meningitis	None	Infections and infestations	None	View
Mucosal infection	None	Infections and infestations	None	View
Otitis externa	None	Infections and infestations	None	View
Otitis media	None	Infections and infestations	None	View
Peripheral nerve infection	None	Infections and infestations	None	View
Phlebitis infective	None	Infections and infestations	None	View
Rash pustular	None	Infections and infestations	None	View
Sepsis	None	Infections and infestations	None	View
Sinusitis	None	Infections and infestations	None	View
Skin infection	None	Infections and infestations	None	View
Small intestine infection	None	Infections and infestations	None	View
Stoma site infection	None	Infections and infestations	None	View
Tooth infection	None	Infections and infestations	None	View
Tracheitis	None	Infections and infestations	None	View
Upper respiratory infection	None	Infections and infestations	None	View
Urinary tract infection	None	Infections and infestations	None	View
Radiation recall reaction (dermatologic)	None	Injury, poisoning and procedural complications	None	View
Vascular access complication	None	Injury, poisoning and procedural complications	None	View
Activated partial thromboplastin time prolonged	None	Investigations	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Alkaline phosphatase increased	None	Investigations	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Blood antidiuretic hormone abnormal	None	Investigations	None	View
Blood bilirubin increased	None	Investigations	None	View
Blood corticotrophin decreased	None	Investigations	None	View
Cholesterol high	None	Investigations	None	View
Creatinine increased	None	Investigations	None	View
Fibrinogen decreased	None	Investigations	None	View
GGT increased	None	Investigations	None	View
Growth hormone abnormal	None	Investigations	None	View
Haptoglobin decreased	None	Investigations	None	View
Investigations - Other, specify	None	Investigations	None	View
Lipase increased	None	Investigations	None	View
Lymphocyte count decreased	None	Investigations	None	View
Neutrophil count decreased	None	Investigations	None	View
Platelet count decreased	None	Investigations	None	View
Reversible posterior leukoencephalopathy syndrome	None	Nervous system disorders	None	View
Seizure	None	Nervous system disorders	None	View
Syncope	None	Nervous system disorders	None	View
Tremor	None	Nervous system disorders	None	View
Trigeminal nerve disorder	None	Nervous system disorders	None	View
Vagus nerve disorder	None	Nervous system disorders	None	View
Agitation	None	Psychiatric disorders	None	View
Anxiety	None	Psychiatric disorders	None	View
Confusion	None	Psychiatric disorders	None	View
Delirium	None	Psychiatric disorders	None	View
Depression	None	Psychiatric disorders	None	View
Hallucinations	None	Psychiatric disorders	None	View
Insomnia	None	Psychiatric disorders	None	View
Personality change	None	Psychiatric disorders	None	View
Suicide attempt	None	Psychiatric disorders	None	View
Acute kidney injury	None	Renal and urinary disorders	None	View
Bladder spasm	None	Renal and urinary disorders	None	View
Chronic kidney disease	None	Renal and urinary disorders	None	View
Proteinuria	None	Renal and urinary disorders	None	View
Renal and urinary disorders - Other, specify	None	Renal and urinary disorders	None	View
Urinary tract obstruction	None	Renal and urinary disorders	None	View
Respiratory, thoracic and mediastinal disorders - Other, specify	None	Respiratory, thoracic and mediastinal disorders	None	View
Sore throat	None	Respiratory, thoracic and mediastinal disorders	None	View
Voice alteration	None	Respiratory, thoracic and mediastinal disorders	None	View
Alopecia	None	Skin and subcutaneous tissue disorders	None	View
Dry skin	None	Skin and subcutaneous tissue disorders	None	View
Hyperhidrosis	None	Skin and subcutaneous tissue disorders	None	View
Pain of skin	None	Skin and subcutaneous tissue disorders	None	View
Pruritus	None	Skin and subcutaneous tissue disorders	None	View
Purpura	None	Skin and subcutaneous tissue disorders	None	View
Rash maculo-papular	None	Skin and subcutaneous tissue disorders	None	View
Skin and subcutaneous tissue disorders - Other, specify	None	Skin and subcutaneous tissue disorders	None	View
Skin hyperpigmentation	None	Skin and subcutaneous tissue disorders	None	View
Skin ulceration	None	Skin and subcutaneous tissue disorders	None	View
Surgical and medical procedures - Other, specify	None	Surgical and medical procedures	None	View
Hematoma	None	Vascular disorders	None	View
Hypertension	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Vascular disorders - Other, specify	None	Vascular disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Oral pain	None	Gastrointestinal disorders	None	View
Pancreatitis	None	Gastrointestinal disorders	None	View
Rectal pain	None	Gastrointestinal disorders	None	View
Stomach pain	None	Gastrointestinal disorders	None	View
Adrenal insufficiency	None	Endocrine disorders	None	View
Endocrine disorders - Other, specify	None	Endocrine disorders	None	View
Hypothyroidism	None	Endocrine disorders	None	View
Blurred vision	None	Eye disorders	None	View
Cataract	None	Eye disorders	None	View
Conjunctivitis	None	Eye disorders	None	View
Extraocular muscle paresis	None	Eye disorders	None	View
Eye disorders - Other, specify	None	Eye disorders	None	View
Eyelid function disorder	None	Eye disorders	None	View
Optic nerve disorder	None	Eye disorders	None	View
Toothache	None	Gastrointestinal disorders	None	View
Typhlitis	None	Gastrointestinal disorders	None	View
Upper gastrointestinal hemorrhage	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Photophobia	None	Eye disorders	None	View
Watering eyes	None	Eye disorders	None	View
Abdominal distension	None	Gastrointestinal disorders	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Anal pain	None	Gastrointestinal disorders	None	View
Ascites	None	Gastrointestinal disorders	None	View
Colitis	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Dental caries	None	Gastrointestinal disorders	None	View
Diarrhea	None	Gastrointestinal disorders	None	View
Dry mouth	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Esophageal pain	None	Gastrointestinal disorders	None	View
Esophageal perforation	None	Gastrointestinal disorders	None	View
Esophagitis	None	Gastrointestinal disorders	None	View
Fecal incontinence	None	Gastrointestinal disorders	None	View
Gastritis	None	Gastrointestinal disorders	None	View
Gastrointestinal disorders - Other, specify	None	Gastrointestinal disorders	None	View
Gastroparesis	None	Gastrointestinal disorders	None	View
Chills	None	General disorders	None	View
Facial pain	None	General disorders	None	View
Fatigue	None	General disorders	None	View
Fever	None	General disorders	None	View
Gait disturbance	None	General disorders	None	View
General disorders and administration site conditions - Other, specify	None	General disorders	None	View
Localized edema	None	General disorders	None	View
Multi-organ failure	None	General disorders	None	View
Non-cardiac chest pain	None	General disorders	None	View
Pain	None	General disorders	None	View
Cholecystitis	None	Hepatobiliary disorders	None	View
Hepatobiliary disorders - Other, specify	None	Hepatobiliary disorders	None	View
Allergic reaction	None	Immune system disorders	None	View
Anaphylaxis	None	Immune system disorders	None	View
Autoimmune disorder	None	Immune system disorders	None	View
Abdominal infection	None	Infections and infestations	None	View
Serum amylase increased	None	Investigations	None	View
Weight gain	None	Investigations	None	View
Weight loss	None	Investigations	None	View
White blood cell decreased	None	Investigations	None	View
Acidosis	None	Metabolism and nutrition disorders	None	View
Anorexia	None	Metabolism and nutrition disorders	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Hypercalcemia	None	Metabolism and nutrition disorders	None	View
Hyperglycemia	None	Metabolism and nutrition disorders	None	View
Hyperkalemia	None	Metabolism and nutrition disorders	None	View
Hypermagnesemia	None	Metabolism and nutrition disorders	None	View
Hypernatremia	None	Metabolism and nutrition disorders	None	View
Hypertriglyceridemia	None	Metabolism and nutrition disorders	None	View
Hyperuricemia	None	Metabolism and nutrition disorders	None	View
Hypoalbuminemia	None	Metabolism and nutrition disorders	None	View
Hypocalcemia	None	Metabolism and nutrition disorders	None	View
Hypoglycemia	None	Metabolism and nutrition disorders	None	View
Hypokalemia	None	Metabolism and nutrition disorders	None	View
Hypomagnesemia	None	Metabolism and nutrition disorders	None	View
Hyponatremia	None	Metabolism and nutrition disorders	None	View
Hypophosphatemia	None	Metabolism and nutrition disorders	None	View
Iron overload	None	Metabolism and nutrition disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Bone pain	None	Musculoskeletal and connective tissue disorders	None	View
Chest wall pain	None	Musculoskeletal and connective tissue disorders	None	View
Generalized muscle weakness	None	Musculoskeletal and connective tissue disorders	None	View
Growth suppression	None	Musculoskeletal and connective tissue disorders	None	View
Muscle weakness left-sided	None	Musculoskeletal and connective tissue disorders	None	View
Muscle weakness lower limb	None	Musculoskeletal and connective tissue disorders	None	View
Muscle weakness right-sided	None	Musculoskeletal and connective tissue disorders	None	View
Muscle weakness upper limb	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal and connective tissue disorder - Other, specify	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Myositis	None	Musculoskeletal and connective tissue disorders	None	View