TriangleNCT01953692 · OUTCOME
Complete Remission Rate (CRR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to approximately 78.5 months
What was measured
CRR was defined as the percentage of participants with complete remission according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. Complete remission was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. Cohort 3 was evaluated statistically by comparing the complete remission for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with complete remission as assessed by the investigator is presented.
Analysis population: All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Groups in this outcome
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
| Group | Source count |
|---|---|
| Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) | 22.6 | Not reported | 11.1 | 38.3 | Not reported |
Source statistical analyses
- group Description
- Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0306
- p Value Comment
- one-sided p-value
- statistical Method
- exact binomial distribution
Complete source fields
- analyses
- group Description
- Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0306
- p Value Comment
- one-sided p-value
- statistical Method
- exact binomial distribution
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- 38.3
- value
- 22.6
- denoms
- counts
- group Id
- OG000
- value
- 31
- units
- Participants
- description
- CRR was defined as the percentage of participants with complete remission according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. Complete remission was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. Cohort 3 was evaluated statistically by comparing the complete remission for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with complete remission as assessed by the investigator is presented.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
- param Type
- NUMBER
- population Description
- All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Complete Remission Rate (CRR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice