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NCT01303965 · OUTCOME

Phase II - Time to Neutrophil Engraftment

Allo Transplant Followed by Lenalidomide and Sirolimus Maintenance in High-Risk Multiple Myeloma (MM) · Source last updated 2019-01-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Transplant (Day 0) through 1 year post transplant

What was measured

Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

Analysis population: All patients who received treatment and survived at least 14 days after transplant

Groups in this outcome

Phase II

Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase II10

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II11Not reported1012Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10
        upper Limit
        12
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.
dispersion Type
95% Confidence Interval
groups
  1. description
    Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance
    id
    OG000
    title
    Phase II
param Type
MEDIAN
population Description
All patients who received treatment and survived at least 14 days after transplant
reporting Status
POSTED
time Frame
Transplant (Day 0) through 1 year post transplant
title
Phase II - Time to Neutrophil Engraftment
type
SECONDARY
unit Of Measure
days

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice