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 @ 12:24 AM
Ignite Modification Date: 2025-12-25 @ 10:29 PM
NCT ID: NCT00671658
Description: None
Frequency Threshold: 5
Time Frame: Up to 8 cycles of 21 days with 7 day waiting period in between (approximately 28 days) then 30 following last treatment, therefore up to 210 days for completed treatment periods.
Study: NCT00671658
Study Brief: Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HYPER-CVAD Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide (CTX) 300 mg/m\^2 IV, Doxorubicin 50 mg/m\^2 IV, Vincristine 2 mg IV, Dexamethasone 40 mg IV or oral (PO). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m\^2 IV followed by 800 mg/m\^2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m\^2 IV for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m\^2 a day IV, Pegylated asparaginase 2000 International units/m\^2 IV. Pegfilgrastim 6 mg (flat dose) within 72 hours after completion of chemotherapy. Solumedrol 40 mg IV for Courses 2,4,6,8. 25 None 61 215 24 220 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vision Loss SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hemorrhage CNS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Psychosis SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Paraparesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Flu-Like Syndrome SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Thrombosis Embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Acute Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Back Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Bactremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Duodenal Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hydro-Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Soft Tissue Necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Acute Pancreatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Arm Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Gastrointestinal Rectum Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hemorrhage Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Lung Hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Musculoskeletal Soft tissue discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Pain Gallbladder SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Partial Small Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Perforated Sigmoid Colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Right Eye Retinal Necrosis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Right Subclavian Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neutropenic Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View