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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT00068250
Description: Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Frequency Threshold: 5
Time Frame: None
Study: NCT00068250
Study Brief: Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
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: Temozolomide 100 mg Rituximab, methotrexate, temozolomide 100 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2. None None 3 6 6 6 View
Phase I: Temozolomide 150 mg Rituximab, methotrexate, temozolomide 150 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2. None None 4 6 6 6 View
Phase II: Temozolomide 100 mg Rituximab, methotrexate, temozolomide 100 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2. None None 16 47 47 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC (2.0) View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC (2.0) View
Vomiting NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTC (2.0) View
Late RT Toxicity:Other NOS SYSTEMATIC_ASSESSMENT General disorders RTOG/EORTC Late Tox. View
Pain-other NON_SYSTEMATIC_ASSESSMENT General disorders CTC (2.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Leukopenia NOS NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Alkalosis NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hyperglycemia NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Ataxia NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Convulsions NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Encephalopathy NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Headache NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Learning disorder NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Speech disorder NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Renal failure NOS NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC (2.0) View
Thrombosis NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTC (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular-Other NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC (2.0) View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC (2.0) View
Diarrhea NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Esophageal spasm NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Esophagitis NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Vomiting NOS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTC (2.0) View
Late RT Toxicity:Other NOS SYSTEMATIC_ASSESSMENT General disorders RTOG/EORTC Late Tox. View
Pain-other NON_SYSTEMATIC_ASSESSMENT General disorders CTC (2.0) View
Rigors NON_SYSTEMATIC_ASSESSMENT General disorders CTC (2.0) View
Hepatic-Other NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTC (2.0) View
Allergy-Other NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTC (2.0) View
Infection NOS NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC (2.0) View
Dermatitis radiation NOS NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTC (2.0) View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTC (2.0) View
Late RT Toxicity:Skin(within RT field)NOS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications RTOG/EORTC Late Tox. View
Operative injury of vein/artery NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTC (2.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Blood alkaline phosphatase NOS increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Leukopenia NOS NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Metabolic-Other NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Prothrombin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Blood bicarbonate decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Blood magnesium decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hyperglycemia NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hypoglycaemia NOS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC (2.0) View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC (2.0) View
Joint, muscle, or bone-Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC (2.0) View
Muscle weakness NOS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC (2.0) View
Amnesia NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Ataxia NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Cerebral ischaemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Convulsions NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Dizziness (exc vertigo) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Late RT Toxicity:Encephalopathy NOS SYSTEMATIC_ASSESSMENT Nervous system disorders RTOG/EORTC Late Tox. View
Neuralgia NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Neurologic-Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Taste disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Tremor NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Anxiety NEC NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC (2.0) View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC (2.0) View
Insomnia NEC NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC (2.0) View
Renal/GU-Other NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC (2.0) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC (2.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC (2.0) View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC (2.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC (2.0) View
Dermatitis exfoliative NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC (2.0) View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC (2.0) View
Pruritus NOS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC (2.0) View
Hypertension NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTC (2.0) View
Thrombosis NOS NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTC (2.0) View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Infection with grade 3 or 4 neutropenia NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTC (2.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Investigations CTC (2.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC (2.0) View
Headache NOS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Late RT Toxicity:Brain NOS SYSTEMATIC_ASSESSMENT Nervous system disorders RTOG/EORTC Late Tox. View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Speech disorder NEC NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTC (2.0) View
Depression NEC NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTC (2.0) View
Erythema multiforme NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC (2.0) View
Skin-Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC (2.0) View
Hematologic-Other NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC (2.0) View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC (2.0) View
Hemolysis NOS NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC (2.0) View
Platelet transfusion NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC (2.0) View
Arrhythmia NOS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTC (2.0) View
Edema NOS NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTC (2.0) View
Cushingoid NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTC (2.0) View
Cataract NEC NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC (2.0) View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC (2.0) View
Dry eye NEC NON_SYSTEMATIC_ASSESSMENT Eye disorders CTC (2.0) View
Late RT Toxicity:Eye NOS SYSTEMATIC_ASSESSMENT Eye disorders RTOG/EORTC Late Tox. View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC (2.0) View