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 @ 2:41 PM
Ignite Modification Date: 2025-12-26 @ 2:41 PM
NCT ID: NCT01360606
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected for a period of up to 5 years.
Study: NCT01360606
Study Brief: Stereotactic Body Radiation Therapy (SBRT) for Liver Mets
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SBRT - 50 Gy Stereotactic Body Radiation Therapy: SBRT: Patients received 50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period. 0 None 0 3 2 3 View
SBRT - 60 Gy Stereotactic Body Radiation Therapy: SBRT: Patients received 60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period. 0 None 0 6 5 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v4 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v4 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v4 View
Hepatobiliary disorders - Other, specifyLDH increased SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v4 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Investigations - Other, specifyedema in lower extremities SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Investigations - Other, specifyLDH increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Investigations - Other, specifyRib pain SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v4 View
Hypermagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v4 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v4 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v4 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v4 View
Skin and subcutaneous tissue disorders - Other, specifyErythema-right breast SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v4 View