TriangleNCT03038672 · OUTCOME
Duration of Response
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
- 2 years
What was measured
Defined as the date at which the patient's objective status is first noted to be a PR or CR for patients evaluated by CT-based criteria or CMR or PMR for patients evaluated by PET-CT based criteria to the earliest date progression (documentation of disease progression \[PMD\] or progressive disease \[PD\]) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test.
Analysis population: All eligible and treated patients that achieve a response.
Groups in this outcome
Group I (Nivolumab)
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
Group II (Varlilumab, Nivolumab)
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Group I (Nivolumab) | 4 |
| Group II (Varlilumab, Nivolumab) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group I (Nivolumab) | NA | Not reported | NA | NA | Due to a lack of events the median and confidence intervals cannot be determined. |
| Group II (Varlilumab, Nivolumab) | 0.2 | Not reported | 0.2 | NA | Due to a lack of events the upper confidence interval cannot be determined. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to a lack of events the median and confidence intervals cannot be determined.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Due to a lack of events the upper confidence interval cannot be determined.
- group Id
- OG001
- lower Limit
- 0.2
- upper Limit
- NA
- value
- 0.2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Defined as the date at which the patient's objective status is first noted to be a PR or CR for patients evaluated by CT-based criteria or CMR or PMR for patients evaluated by PET-CT based criteria to the earliest date progression (documentation of disease progression \[PMD\] or progressive disease \[PD\]) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
- id
- OG000
- title
- Group I (Nivolumab)
- description
- Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Group II (Varlilumab, Nivolumab)
- param Type
- MEDIAN
- population Description
- All eligible and treated patients that achieve a response.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- years
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice