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 @ 2:59 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT00290433
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
Study: NCT00290433
Study Brief: Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell 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
HCVIDDOXIL Regimen Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14. Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3. None None 1 53 46 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
massive cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infectious Disease SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Liver Toxicities SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View