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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT00381004
Description: None
Frequency Threshold: 5
Time Frame: Adverse event collection through total of 6 courses administered, courses are 28 to 42 days (+/- 7 days) depending on recovery of peripheral blood counts and assessments for toxicities after 3 and 6 courses, up to 252 days.
Study: NCT00381004
Study Brief: FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic 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
FCR + Sargramostim Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m\^2 IV Days 2-4; Course 2-6: 25 mg/m\^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m\^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m\^2 Days 1-3. Rituximab - Course 1: 375 mg/m\^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m\^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m\^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m\^2 SQ Days -1 and 4-10. None None 12 60 4 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DIARRHEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
DEATH SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
FEVER OF UNKNOWN ORIGIN SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
SECONDARY MALIGNANCY DUCTAL CARCINOMA IN SITU RIGHT BREAST SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
SECONDARY MALIGNANCY MDS SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
SECONDARY MALIGNANCY SQUAMOUS CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
ENCEPHALOATHY SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders 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
Pain/erythema at injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View