TriangleNCT02332980 · OUTCOME
Proportion of Patients Who Achieve a Confirmed Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of responders
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 1 year
What was measured
Confirmed response is defined to be a partial response, nodular partial response, clinical complete response, confirmed response with incomplete blood count recovery or confirmed response (Arm A and B), or complete metabolic response, partial metabolic response, partial response, or confirmed response (Arm C). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
Groups in this outcome
Arm A (CLL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
Arm B (NHL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
| Group | Source count |
|---|---|
| Arm A (CLL) | 25 |
| Arm B (NHL) | 23 |
| Arm C (CLL With Richters) | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (CLL) | 0.0800 | Not reported | 0.0098 | 0.2603 | Not reported |
| Arm B (NHL) | 0 | Not reported | 0 | 0.1482 | Not reported |
| Arm C (CLL With Richters) | 0 | Not reported | 0 | 0.1951 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0098
- upper Limit
- 0.2603
- value
- 0.0800
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0.1482
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 0.1951
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- Confirmed response is defined to be a partial response, nodular partial response, clinical complete response, confirmed response with incomplete blood count recovery or confirmed response (Arm A and B), or complete metabolic response, partial metabolic response, partial response, or confirmed response (Arm C). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
- id
- OG000
- title
- Arm A (CLL)
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG001
- title
- Arm B (NHL)
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
- id
- OG002
- title
- Arm C (CLL With Richters)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Proportion of Patients Who Achieve a Confirmed Response
- type
- PRIMARY
- unit Of Measure
- proportion of responders
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice