TriangleNCT02155647 · OUTCOME
Part A: Interim Analysis: Overall Survival (OS) Time
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016)
What was measured
The OS time was defined as the time from first administration of trial treatment until death. The OS time was analyzed using the Kaplan-Meier method.
Analysis population: Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment.
Groups in this outcome
Part A: Avelumab
Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
| Group | Source count |
|---|---|
| Part A: Avelumab | 88 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Avelumab | 11.3 | Not reported | 7.5 | 14.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- 14.0
- value
- 11.3
- denoms
- counts
- group Id
- OG000
- value
- 88
- units
- Participants
- description
- The OS time was defined as the time from first administration of trial treatment until death. The OS time was analyzed using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- id
- OG000
- title
- Part A: Avelumab
- param Type
- MEDIAN
- population Description
- Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016)
- title
- Part A: Interim Analysis: Overall Survival (OS) Time
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice