TriangleNCT01953692 · OUTCOME
Duration of Response (DOR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
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
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
Analysis population: All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Groups in this outcome
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
| Group | Source count |
|---|---|
| Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D) | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D) | NA | Not reported | 9.6 | NA | NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG000
- lower Limit
- 9.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
- param Type
- MEDIAN
- population Description
- All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Duration of Response (DOR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice