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: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT00100802
Description: Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
Frequency Threshold: 0
Time Frame: None
Study: NCT00100802
Study Brief: Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle. lomustine: Capsule temozolomide: Capsule adjuvant therapy radiation therapy None None 3 106 83 106 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrophil count decreased None Investigations None View
White blood cell decreased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell decreased None Investigations None View
Anorexia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Glucose intolerance None Metabolism and nutrition 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
Seizure None Nervous system disorders None View
Eye disorders - Other, specify None Eye disorders None View
Allergic reaction None Immune system disorders None View
Anemia None Blood and lymphatic system disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Hemolysis None Blood and lymphatic system disorders None View
Cushingoid None Endocrine disorders None View
Endocrine disorders - Other, specify None Endocrine disorders None View
Extraocular muscle paresis None Eye disorders None View
Papilledema None Eye disorders None View
Abdominal pain None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dysphagia None Gastrointestinal disorders None View
Intra-abdominal hemorrhage None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Oral pain None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Edema limbs None General disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Gait disturbance None General disorders None View
Anorectal infection None Infections and infestations None View
Appendicitis None Infections and infestations None View
Catheter related infection None Infections and infestations None View
Gum infection None Infections and infestations None View
Infections and infestations - Other, specify None Infections and infestations None View
Meningitis None Infections and infestations None View
Skin infection None Infections and infestations None View
Upper respiratory infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Burn None Injury, poisoning and procedural complications None View
Radiation recall reaction (dermatologic) None Injury, poisoning and procedural complications None View
Alanine aminotransferase increased None Investigations None View
Alkaline phosphatase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Blood bilirubin increased None Investigations None View
GGT increased None Investigations None View
Investigations - Other, specify 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
Hyperglycemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Tumor pain None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Abducens nerve disorder None Nervous system disorders None View
Ataxia None Nervous system disorders None View
Depressed level of consciousness None Nervous system disorders None View
Dysphasia None Nervous system disorders None View
Headache None Nervous system disorders None View
Hydrocephalus None Nervous system disorders None View
IVth 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
Syncope None Nervous system disorders None View
Depression None Psychiatric disorders None View
Personality change None Psychiatric disorders None View
Psychosis None Psychiatric disorders None View
Epistaxis 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
Erythema multiforme None Skin and subcutaneous tissue disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Thromboembolic event None Vascular disorders None View