TriangleNCT03038672 · OUTCOME
Overall Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 years
What was measured
Will be assessed by computed tomography (CT)-based criteria or positron emission tomography (PET)-CT based criteria. A response will be defined as an objective status of partial remission (PR) or complete remission (CR) for patients evaluated by CT-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) for patients evaluated by PET-CT based criteria. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm. Comparison of overall response rates between the two treatment groups will be performed using a one-sided Fisher's exact test at significance level 0.15.
Analysis population: All eligible patients that had a disease evaluation after being treated.
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) | 25 |
| Group II (Varlilumab, Nivolumab) | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group I (Nivolumab) | 0.16 | Not reported | 0.045 | 0.361 | Not reported |
| Group II (Varlilumab, Nivolumab) | 0.08 | Not reported | 0.010 | 0.251 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.045
- upper Limit
- 0.361
- value
- 0.16
- group Id
- OG001
- lower Limit
- 0.010
- upper Limit
- 0.251
- value
- 0.08
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- Will be assessed by computed tomography (CT)-based criteria or positron emission tomography (PET)-CT based criteria. A response will be defined as an objective status of partial remission (PR) or complete remission (CR) for patients evaluated by CT-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) for patients evaluated by PET-CT based criteria. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm. Comparison of overall response rates between the two treatment groups will be performed using a one-sided Fisher's exact test at significance level 0.15.
- 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
- NUMBER
- population Description
- All eligible patients that had a disease evaluation after being treated.
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice