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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:11 AM
NCT ID: NCT00794820
Description: Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response.
Frequency Threshold: 2
Time Frame: Adverse events collected through 6 courses; courses repeated every 4-6 weeks, up to 36 weeks.
Study: NCT00794820
Study Brief: Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FCR-Multiple Dose Rituximab Fludarabine phosphate 25 mg/m\^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m\^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m\^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m\^2 on days 2-3 None None 30 65 63 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Bacteria Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations 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
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Other Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View