TriangleNCT02148913 · OUTCOME
Neutrophil Engraftment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- days
- Interval / dispersion
- Standard Deviation
- Time frame
- Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
What was measured
Engraftment of Neutrophils: ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 x 109/L for three consecutive laboratory values obtained on different days. The day used as neutrophil engraftment is the date of the first of three laboratory values. Graft Failure: Graft failure includes failure to achieve neutrophil engraftment by day 22.
Groups in this outcome
Cohort 1: Carfilzomib 15 mg/m2
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
Cohort 2: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
Cohort 2b: Carfilzomib 20 mg/m2
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
Cohort 3: Carfilzomib 27mgm2
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
| Group | Source count |
|---|---|
| Cohort 1: Carfilzomib 15 mg/m2 | 3 |
| Cohort 2: Carfilzomib 20 mg/m2 | 3 |
| Cohort 2b: Carfilzomib 20 mg/m2 | 3 |
| Cohort 3: Carfilzomib 27mgm2 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Carfilzomib 15 mg/m2 | 11.33 | 0.58 | Not reported | Not reported | Not reported |
| Cohort 2: Carfilzomib 20 mg/m2 | 12.67 | 2.08 | Not reported | Not reported | Not reported |
| Cohort 2b: Carfilzomib 20 mg/m2 | 12 | 0 | Not reported | Not reported | Not reported |
| Cohort 3: Carfilzomib 27mgm2 | 12.11 | 0.78 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.58
- value
- 11.33
- group Id
- OG001
- spread
- 2.08
- value
- 12.67
- group Id
- OG002
- spread
- 0
- value
- 12
- group Id
- OG003
- spread
- 0.78
- value
- 12.11
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- units
- Participants
- description
- Engraftment of Neutrophils: ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 x 109/L for three consecutive laboratory values obtained on different days. The day used as neutrophil engraftment is the date of the first of three laboratory values. Graft Failure: Graft failure includes failure to achieve neutrophil engraftment by day 22.
- dispersion Type
- Standard Deviation
- groups
- description
- Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
- id
- OG000
- title
- Cohort 1: Carfilzomib 15 mg/m2
- description
- Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
- id
- OG001
- title
- Cohort 2: Carfilzomib 20 mg/m2
- description
- Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
- id
- OG002
- title
- Cohort 2b: Carfilzomib 20 mg/m2
- description
- Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
- id
- OG003
- title
- Cohort 3: Carfilzomib 27mgm2
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
- title
- Neutrophil Engraftment
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice