NCT02148913 · OUTCOME
Platelet 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 Platelets: Platelet engraftment is defined as a platelet count ≥ 20 x 109/L for 3 consecutive measurements obtained on different days. The patient must not have received a platelet infusion for seven consecutive days prior to the first day being considered. The day used as platelet engraftment is the date of the first of three laboratory values.
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 | 2 |
| 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 | 17 | 2.65 | Not reported | Not reported | Not reported |
| Cohort 2: Carfilzomib 20 mg/m2 | 15.5 | 0.71 | Not reported | Not reported | Not reported |
| Cohort 2b: Carfilzomib 20 mg/m2 | 15.67 | 3.51 | Not reported | Not reported | Not reported |
| Cohort 3: Carfilzomib 27mgm2 | 15.89 | 1.96 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.65
- value
- 17
- group Id
- OG001
- spread
- 0.71
- value
- 15.5
- group Id
- OG002
- spread
- 3.51
- value
- 15.67
- group Id
- OG003
- spread
- 1.96
- value
- 15.89
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- units
- Participants
- description
- Engraftment of Platelets: Platelet engraftment is defined as a platelet count ≥ 20 x 109/L for 3 consecutive measurements obtained on different days. The patient must not have received a platelet infusion for seven consecutive days prior to the first day being considered. The day used as platelet engraftment is the date of the first of three laboratory values.
- 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
- Platelet Engraftment
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice
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