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 @ 4:00 PM
Ignite Modification Date: 2025-12-26 @ 4:00 PM
NCT ID: NCT01949506
Description: None
Frequency Threshold: 0
Time Frame: 3 years
Study: NCT01949506
Study Brief: (SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Stereotactic Body Radiation Therapy Arms: Stereotactic Body Radiation Therapy (SBRT) with Adaptive Radiation Therapy (ART) for all patients. A non-randomized study. Patients must have 1-5 pulmonary metastases all less than 5 cm in size. Pathologic confirmation of primary soft tissue sarcoma. All lesions to receive 3-5 fractions to each tumor. Treatments delivered with \> 10 Gy per fraction will have a minimum of 48 hour interfraction interval. For treatments with ≤ 10 Gy per fraction will have a minimum 24 hour interfraction interval. Treatments will be ideally completed over 14 days for 3 fraction treatments and over 21 days for \>5 fraction treatment schedules. SBRT: Stereotactic Body Radiation Therapy 3 None 3 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Burning sensation in chest SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 4.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View