TriangleNCT02453594 · OUTCOME
Complete Remission Rate (CRR) by BICR Based on Lugano Criteria
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
- Not reported
- Time frame
- Up to approximately 99 months
What was measured
CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the Lugano criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.
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 | 34.8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 28.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 35.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34.8
- group Id
- OG001
- value
- 28.4
- group Id
- OG002
- value
- 35.0
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 81
- group Id
- OG002
- value
- 60
- units
- Participants
- description
- CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the Lugano criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.
- 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
- NUMBER
- 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
- Complete Remission Rate (CRR) by BICR Based on Lugano Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice