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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT00105560
Description: Acute toxicity is assessed weekly during craniospinal irradiation (CSI) treatment and late side effects/complications are assessed during routine clinic visits starting at 90 days after the completion of radiation therapy. Participants were assessed for toxicity for the duration of followup, meaning until the patient withdraws from the study, is taken off the protocol, or dies.
Frequency Threshold: 0
Time Frame: Through study completion, median duration of 7 years
Study: NCT00105560
Study Brief: Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radiation Therapy radiation therapy: Radiation therapy with proton beam to standard doses 13 None 13 59 59 59 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
esophhagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Radiation dermatitis (scalp or back) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Cataracts SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Truncal muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
CNS brainstem injury SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (3.0) View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View