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 @ 4:56 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT00736450
Description: Only reporting all Serious adverse events and Other AEs grade 3 and 4.
Frequency Threshold: 5
Time Frame: Participants adverse event data was collected from time of initial study drug dosing until completed study treatment. (approximately 6 months)
Study: NCT00736450
Study Brief: Oblimersen Sodium & Combination Chemotherapy in Treating Patients With Newly Diagnosed Diffuse Large B-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
Arm I Patients in this study who are found to have the Activated B-Cell (ABC) type after gene expression profiling or Immunohistochemistry (IHC) staining will receive combination chemotherapy with the standard CHOP-R with Genasense (oblimersen) (anti-bcl2 oligonucleotide). oblimersen sodium: Given IV rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate: Given IV prednisone: Given orally 0 None 2 14 12 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
White blood cells decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Infections and infestations - Other 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
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Injury, poisoning and procedural complications - Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Infections and infestations - Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View