TriangleNCT02145403 · OUTCOME
Phase II: Cumulative Incidence of Acute GVHD
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
- At day 180 post-transplant; data collected up to 3 years
What was measured
The cumulative incidence of acute Graft Versus Host Disease (aGVHD). Events were assigned a severity grade using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0; lower values indicate least severe and higher values indicate most severe. Grades 2 - 4 and grades 3 - 4 events are reported. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis.
Analysis population: Subjects who have received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m\^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis of the primary outcome measure.
Groups in this outcome
Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2
Participants were administered 20 mg/m\^2 on days 1 and 2; 36 mg/m\^2 of Carfilzomib on days 6 and 7.
| Group | Source count |
|---|---|
| Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 | 39 |
Reported measurements
Acute GVHD grade 2-4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 | 32 | Not reported | 21 | 48 | Not reported |
Acute GVHD grade 3-4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2 | 15 | Not reported | 7 | 29 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21
- upper Limit
- 48
- value
- 32
- title
- Acute GVHD grade 2-4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7
- upper Limit
- 29
- value
- 15
- title
- Acute GVHD grade 3-4
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- description
- The cumulative incidence of acute Graft Versus Host Disease (aGVHD). Events were assigned a severity grade using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0; lower values indicate least severe and higher values indicate most severe. Grades 2 - 4 and grades 3 - 4 events are reported. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered 20 mg/m\^2 on days 1 and 2; 36 mg/m\^2 of Carfilzomib on days 6 and 7.
- id
- OG000
- title
- Dose Level 3 - Maximum Dose Carfilzomib 36 mg/m^2
- param Type
- NUMBER
- population Description
- Subjects who have received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m\^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis of the primary outcome measure.
- reporting Status
- POSTED
- time Frame
- At day 180 post-transplant; data collected up to 3 years
- title
- Phase II: Cumulative Incidence of Acute GVHD
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice