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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
NCT ID:
NCT03630120
Group ID:
EG001
Title:
Adaptive Care: DTC
Description:
SOC followed by Adaptive Care TKI Therapy for DTC Participants with \>=50% drop: Lenvatinib + Sorafenib.
Lenvatinib: Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.
Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.
Sorafenib: Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.
Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment ("baseline" level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the "baseline" level.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
2
Other Number Affected:
0
Other Number At Risk:
2
Study:
NCT03630120
Results Section:
NCT03630120
Adverse Events Module:
NCT03630120