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 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:20 PM
NCT ID: NCT00472056
Description: None
Frequency Threshold: 5
Time Frame: 4 Years, 5 Months
Study: NCT00472056
Study Brief: Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 65 Years of Age or Less With Arm 2 Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab None None 14 25 24 25 View
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1 Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab None None 9 19 18 19 View
Cohort 1 65 Years of Age or Less With Arm 1 Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab None None 9 32 31 32 View
Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2 Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab None None 8 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Neutropenic fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Low Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Failure to Thrive SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View