TriangleNCT02453594 · OUTCOME
Progression-free Survival (PFS) Based on BICR
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 99 months
What was measured
PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first based on BICR. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment.
Analysis population: All allocated participants who received at least 1 dose of study treatment.
Groups in this outcome
Cohort 1
Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
Cohort 2
Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
Cohort 3
Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
| Group | Source count |
|---|---|
| Cohort 1 | 69 |
| Cohort 2 | 81 |
| Cohort 3 | 60 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 16.5 | Not reported | 12.0 | 30.3 | Not reported |
| Cohort 2 | 11.1 | Not reported | 7.5 | 13.7 | Not reported |
| Cohort 3 | 19.7 | Not reported | 10.8 | 32.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- 30.3
- value
- 16.5
- group Id
- OG001
- lower Limit
- 7.5
- upper Limit
- 13.7
- value
- 11.1
- group Id
- OG002
- lower Limit
- 10.8
- upper Limit
- 32.9
- value
- 19.7
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 81
- group Id
- OG002
- value
- 60
- units
- Participants
- description
- PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first based on BICR. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
- id
- OG000
- title
- Cohort 1
- description
- Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
- id
- OG001
- title
- Cohort 2
- description
- Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
- id
- OG002
- title
- Cohort 3
- param Type
- MEDIAN
- population Description
- All allocated participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 99 months
- title
- Progression-free Survival (PFS) Based on BICR
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice