TriangleNCT02576990 · OUTCOME
Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses
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 27 months (Database Cutoff Date: 28MAY2019)
What was measured
The DOR was defined, only for the subgroup of participants who achieved a CR or PR by independent central review, as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. The analysis consisted of Kaplan-Meier estimates. DOR data was censored on the date of the last disease assessment documenting absence of PD for participants who did not have tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment, or were removed from study prior to documentation of tumor progression.
Analysis population: The analysis population included all participants who received at least one dose of study medication (pembrolizumab) and who achieved a CR or PR by independent central review, as the time from start of the first documentation of objective tumor response (CR or PR).
Groups in this outcome
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
| Group | Source count |
|---|---|
| Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 24 |
| Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | NA | Not reported | 25.2 | NA | NA = Median DOR was not reached (no progressive disease by time of last disease assessment). NA = DOR upper limit was not reached (no progressive disease by time of last disease assessment). |
| Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 4.5 | Not reported | 2.7 | 6.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Median DOR was not reached (no progressive disease by time of last disease assessment). NA = DOR upper limit was not reached (no progressive disease by time of last disease assessment).
- group Id
- OG000
- lower Limit
- 25.2
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 2.7
- upper Limit
- 6.2
- value
- 4.5
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- The DOR was defined, only for the subgroup of participants who achieved a CR or PR by independent central review, as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. The analysis consisted of Kaplan-Meier estimates. DOR data was censored on the date of the last disease assessment documenting absence of PD for participants who did not have tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment, or were removed from study prior to documentation of tumor progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
- id
- OG000
- title
- Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
- description
- Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
- id
- OG001
- title
- Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
- param Type
- MEDIAN
- population Description
- The analysis population included all participants who received at least one dose of study medication (pembrolizumab) and who achieved a CR or PR by independent central review, as the time from start of the first documentation of objective tumor response (CR or PR).
- reporting Status
- POSTED
- time Frame
- Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
- title
- Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice