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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT00547534
Description: None
Frequency Threshold: 5
Time Frame: Two years
Study: NCT00547534
Study Brief: Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's 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
Lymphoma Subjects Subjects that met all eligibility criteria and were given study treatment. None None 13 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Liver Failure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Renal Failure SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Rigors / chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Allergic reaction SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pruritis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Stomach/abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View