TriangleNCT05316701 · OUTCOME
Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC
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
- 95% Confidence Interval
- Time frame
- Day 0 through 730 days after transplantation
What was measured
Event rate estimated at 12 months for time from alloHCT to first onset of moderate or severe cGVHD defined by NIH consensus criteria within 2 years after day 0. Death within 2 years after day 0 without prior moderate or severe cGVHD was considered a competing event. cGVHD was assessed and graded by an independent EAC. Each participant in the study is followed for up to 730 days after transplant. The primary analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event rate of moderate or severe cGVHD at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
Analysis population: ITT
Groups in this outcome
Orca-T
Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
Standard of Care
Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
| Group | Source count |
|---|---|
| Orca-T | 93 |
| Standard of Care | 94 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Orca-T | 12.6 | Not reported | 5.3 | 23.1 | Not reported |
| Standard of Care | 44.0 | Not reported | 31.3 | 56.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.43
- group Description
- Gray's test was stratified by randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.19
- statistical Method
- Gray's test
Complete source fields
- analyses
- ci Lower Limit
- 0.08
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.43
- group Description
- Gray's test was stratified by randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.19
- statistical Method
- Gray's test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.3
- upper Limit
- 23.1
- value
- 12.6
- group Id
- OG001
- lower Limit
- 31.3
- upper Limit
- 56.1
- value
- 44.0
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 94
- units
- Participants
- description
- Event rate estimated at 12 months for time from alloHCT to first onset of moderate or severe cGVHD defined by NIH consensus criteria within 2 years after day 0. Death within 2 years after day 0 without prior moderate or severe cGVHD was considered a competing event. cGVHD was assessed and graded by an independent EAC. Each participant in the study is followed for up to 730 days after transplant. The primary analysis was triggered by the 56th cGFS event (ie, when 56 participants had died or had moderate or severe chronic GVHD) and was not based on the duration of follow-up. Therefore, the analysis was conducted using all available data at the time that the 56th cGFS event occurred, and the event rate of moderate or severe cGVHD at 12 months was estimated regardless of the length of follow-up for individual participants. At the time of analysis, not all participants have reached 730 days of follow-up because they enrolled at different times.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Orca-T administered after myeloablative conditioning followed by single-agent tacrolimus
- id
- OG000
- title
- Orca-T
- description
- Unmanipulated allograft from peripheral blood of a matched donor after myeloablative conditioning followed by tacrolimus and methotrexate
- id
- OG001
- title
- Standard of Care
- param Type
- NUMBER
- population Description
- ITT
- reporting Status
- POSTED
- time Frame
- Day 0 through 730 days after transplantation
- title
- Event Rate at 12 Months for Time to Moderate or Severe cGVHD Per EAC
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice