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NCT03317899 · OUTCOME

Number of Days to Discharge

Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma · Source last updated 2025-12-17

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Up to 60 days

What was measured

Will compare days to discharge readiness between the two groups.

Groups in this outcome

Group I (auto HSCT tbo-filgrastim)

Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies

Group II (auto HSCT)

Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies

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

Analysis denominator · Participants

GroupSource count
Group I (auto HSCT tbo-filgrastim)38
Group II (auto HSCT)39

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Group I (auto HSCT tbo-filgrastim)11Not reported826Not reported
Group II (auto HSCT)15Not reported1129Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Weibull accelerated failure time model; adjusted for disease type and stem cell collection days; non-inferiority declared if 90% CI upper bound for acceleration factor \< 1.133 (≤13.3% increase in discharge readiness time); one-sided α = 0.05; sample size for \~80% power; O'Brien-Fleming futility boundary applied.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.001
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Weibull accelerated failure time model; adjusted for disease type and stem cell collection days; non-inferiority declared if 90% CI upper bound for acceleration factor \< 1.133 (≤13.3% increase in discharge readiness time); one-sided α = 0.05; sample size for \~80% power; O'Brien-Fleming futility boundary applied.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.001
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8
        upper Limit
        26
        value
        11
      2. group Id
        OG001
        lower Limit
        11
        upper Limit
        29
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Will compare days to discharge readiness between the two groups.
dispersion Type
Full Range
groups
  1. description
    Beginning on day 3 after auto Hematopoietic Cell Transplantation (HSCT), patients receive tbo-filgrastim SC daily for 12-14 days. Hematopoietic Cell Transplantation: Undergo auto HSCT Tbo-filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Correlative Studies
    id
    OG000
    title
    Group I (auto HSCT tbo-filgrastim)
  2. description
    Patients undergo auto Hematopoietic Cell Transplantation (HSCT). Hematopoietic Cell Transplantation: Undergo auto HSCT Laboratory Biomarker Analysis: Correlative Studies
    id
    OG001
    title
    Group II (auto HSCT)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 60 days
title
Number of Days to Discharge
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice