Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
NCT ID:
NCT02364557
Group ID:
EG001
Title:
Standard of Care + Ablation (Arm 2)
Description:
Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician.
Stereotactic Body Radiotherapy: Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry.
* For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy.
* For a single liver metastases, patients receive a single fraction of 30 Gy.
* For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy.
* For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy.
* For spinal metastases, patients receive 1 fraction of 20 Gy.
* For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy.
* For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy.
Surgery: All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.
Deaths Number Affected:
17
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
57
Other Number Affected:
50
Other Number At Risk:
57
Study:
NCT02364557
Results Section:
NCT02364557
Adverse Events Module:
NCT02364557