TriangleNCT02181738 · OUTCOME
Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C
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
- From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
What was measured
The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
Analysis population: All treated Cohort A, B and C participants who had a BOR of CR.
Groups in this outcome
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
| Group | Source count |
|---|---|
| Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin | 20 |
| Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant | 11 |
| Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin | 43.47 | Not reported | 18.00 | NA | The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology. |
| Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant | 30.32 | Not reported | 2.4 | NA | The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology. |
| Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant | 26.41 | Not reported | 7.13 | NA | The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
- group Id
- OG000
- lower Limit
- 18.00
- upper Limit
- NA
- value
- 43.47
- comment
- The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
- group Id
- OG001
- lower Limit
- 2.4
- upper Limit
- NA
- value
- 30.32
- comment
- The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
- group Id
- OG002
- lower Limit
- 7.13
- upper Limit
- NA
- value
- 26.41
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 21
- units
- Participants
- description
- The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by \>=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition. Computed using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
- id
- OG000
- title
- Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
- description
- Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
- id
- OG001
- title
- Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
- description
- Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
- id
- OG002
- title
- Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
- param Type
- MEDIAN
- population Description
- All treated Cohort A, B and C participants who had a BOR of CR.
- reporting Status
- POSTED
- time Frame
- From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
- title
- Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice