TriangleNCT01953692 · OUTCOME
Progression-free Survival (PFS) 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 78.5 months
What was measured
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, \>50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a \>50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; \>50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS 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) | 8.7 | Not reported | 4.9 | 28.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.9
- upper Limit
- 28.1
- value
- 8.7
- denoms
- counts
- group Id
- OG000
- value
- 31
- units
- Participants
- description
- PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, \>50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a \>50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; \>50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
- dispersion Type
- 95% 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
- MEDIAN
- 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
- Progression-free Survival (PFS) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice