TriangleNCT00002663 · OUTCOME
Overall Survival (OS)
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 Day 1 through 251.1 months after Day 1 dose
What was measured
The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
Analysis population: Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with \<= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Groups in this outcome
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only) | 11 |
| EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only) | 4 |
| EBV+ LMS (Tab-cel Only) | 5 |
| EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only) | 23 |
| EBV+ Viremia (EBV-CTLs Only) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only) | 14.8 | Not reported | 0.9 | NA | Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis. |
| EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only) | 84.8 | Not reported | 1.1 | 115.0 | Not reported |
| EBV+ LMS (Tab-cel Only) | NA | Not reported | 60.6 | NA | Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis. |
| EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only) | 18.6 | Not reported | 1.5 | NA | Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis. |
| EBV+ Viremia (EBV-CTLs Only) | NA | Not reported | 2.5 | NA | Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis.
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- NA
- value
- 14.8
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 115.0
- value
- 84.8
- comment
- Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis.
- group Id
- OG002
- lower Limit
- 60.6
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis.
- group Id
- OG003
- lower Limit
- 1.5
- upper Limit
- NA
- value
- 18.6
- comment
- Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis.
- group Id
- OG004
- lower Limit
- 2.5
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 23
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- The OS is defined as the time from the first dose of tabelecleucel or EBV-CTLs to the date of death due to any cause. The OS was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
- description
- Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
- description
- Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- EBV+ LMS (Tab-cel Only)
- description
- Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
- description
- Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- EBV+ Viremia (EBV-CTLs Only)
- param Type
- MEDIAN
- population Description
- Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Results from arms with \<= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 251.1 months after Day 1 dose
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice