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 @ 4:41 PM
Ignite Modification Date: 2025-12-25 @ 2:30 PM
NCT ID: NCT00002766
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00002766
Study Brief: Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or 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
All-2 ARA-C/High-Dose Mitoxantrone("All-2") None None 39 81 49 81 View
L-20 Standard Vincristine/Prednisone ("L-20") None None 33 89 42 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysphagia, esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Fibrinogen SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Hand-Foot Skin reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC-2.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Hematuria SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Hemoglobin (Hgb) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Hemorrhage, other SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Hepatic enlargement SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC-2.0 View
Hepatic, other SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC-2.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Ileus (or neuroconstipation) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
infection SYSTEMATIC_ASSESSMENT Infections and infestations CTC-2.0 View
Infection with grade 3/4 neutrophils SYSTEMATIC_ASSESSMENT Infections and infestations CTC-2.0 View
Infection/Febrible Neutrophil-Other SYSTEMATIC_ASSESSMENT Infections and infestations CTC-2.0 View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC-2.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Neurology, other SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-2.0 View
Neuropathy-motor SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-2.0 View
Neutrophils (Leukemia) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Pain, other SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Pulmonary, other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTC-2.0 View
SGOT (AST) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
SGPT (ALT) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-2.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Syncope SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Vision-blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTC-2.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Supravent arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Stomatitis/pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Neutrophils SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Gastrointestinal, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-2.0 View
Dermatology, skin other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC-2.0 View
Dehydration SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Cardiovascular, Arrhythmia other SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Ascites SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
ALT, SGPT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Adult respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Abdominal pain/cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Acidosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Amylase SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Ataxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Blood,Bone marrow,other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Bone pain SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Cardiac left ventricle SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Cardiovascular, other SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-2.0 View
Colitits SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain/cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Anorexia SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Bone pain SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-2.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-2.0 View
Insomnia SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Muscle weakness SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Pain, other SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
Prothrombin Time SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Rigors, chills SYSTEMATIC_ASSESSMENT General disorders CTC-2.0 View
SGPT (ALT) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-2.0 View
Stomatitis/pharyngitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-2.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTC-2.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTC-2.0 View
Vision-blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTC-2.0 View