NCT03617913 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From registration to time of first documentation of progression or death from any cause, assessed up to 12 months
What was measured
Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.
Analysis population: All patients who registered and were treated are included in this analysis.
Groups in this outcome
Avelumab and Cisplatin IV
Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Avelumab and Cisplatin IV | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab and Cisplatin IV | NA | Not reported | NA | NA | Too few events have occurred to obtain a median or a 95% CI. |
Complete source fields
- classes
- categories
- measurements
- comment
- Too few events have occurred to obtain a median or a 95% CI.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- description
- Progression-free survival is defined as the time from registration to the time of progression or death. This study will not use RECIST criteria to evaluate response or progression. The patients enrolled will have non-measurable disease on imaging and response will be evaluated with biopsy or cytology. Progression is defined as progression in T stage, N stage or M stage both clinically or radiologically. Histological confirmation of metastatic disease is at the discretion of the treating provider. The median time will be estimated using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Avelumab and Cisplatin IV
- param Type
- MEDIAN
- population Description
- All patients who registered and were treated are included in this analysis.
- reporting Status
- POSTED
- time Frame
- From registration to time of first documentation of progression or death from any cause, assessed up to 12 months
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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