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: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT00145600
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from the date a patient went on study through the completion of therapy. The elapsed timeframe for adverse event collection was eleven years (March, 2000 through May, 2011).
Study: NCT00145600
Study Brief: Therapy for Pediatric Hodgkin 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
Favorable Risk Ann Arbor stage IA or IIA with: 1. Non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x-ray) 2. \< 3 nodal regions involved on the same side of the diaphragm 3. No extranodal extension of disease None None 0 91 54 88 View
Intermediate Risk Stage must be classified as one of the following: 1. Ann Arbor stage IB and IIIA 2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) None None 0 46 39 46 View
Unfavorable Risk, Group 1 Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13). None None 0 13 12 13 View
Unfavorable Risk, Group 2 Stage must be classified as one of the following: a. Ann Arbor stage IIB, IIIB, or any IV None None 1 146 116 146 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombosis/thrombus/embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hemoglobin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Leukocytes (total WBC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutrophils/granulocytes (ANC/AGC) NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platelets NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis/stomatitis (functional/symptomatic), Oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC<1.0x10e NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Infection with unknown ANC, Blood NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
AST, SGOT(serum glutamic oxaloacetic transaminase) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Bilirubin (hyperbilirubinemia) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Potassium, serum-low (hypokalemia) NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View