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NCT04682405 · OUTCOME

Median Daily Dose of Anti-diarrheal Medications

Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM) · Source last updated 2023-12-15

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

Measure
MEDIAN
Unit
number of doses in one day
Interval / dispersion
Full Range
Time frame
Through date of discharge (up to be 18 days)

What was measured

This is defined as the number of doses of anti-diarrheal medications, such as loperamide or lomotil, that participants took daily.

Analysis population: The number of participants analyzed at each time point may differ from the overall number of participants analyzed because the data was not collected. One patient in the placebo + standard of care melphalan arm was not evaluable for the outcome measure.

Groups in this outcome

Uproleselan + Standard of Care Melphalan

Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.

Placebo + Standard of Care Melphalan

Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.

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

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan21

Reported measurements

Source class 1
Values in number of doses in one day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.20Not reported1.004.33Not reported
Placebo + Standard of Care Melphalan2.00Not reported1.005.50Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        4.33
        value
        2.20
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        5.50
        value
        2.00
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      21
    units
    Participants
description
This is defined as the number of doses of anti-diarrheal medications, such as loperamide or lomotil, that participants took daily.
dispersion Type
Full Range
groups
  1. description
    Patients will receive six doses of Uproleselan intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.
    id
    OG000
    title
    Uproleselan + Standard of Care Melphalan
  2. description
    Patients will receive six doses of placebo intravenously. The doses will begin the evening of Day -3 and continue every 12 hours through the morning of Day 0, prior to hematopoietic stem cell transplant (auto-HCT). On the evening of Day -2, patients also receive one dose of standard of care Melphalan intravenously.
    id
    OG001
    title
    Placebo + Standard of Care Melphalan
param Type
MEDIAN
population Description
The number of participants analyzed at each time point may differ from the overall number of participants analyzed because the data was not collected. One patient in the placebo + standard of care melphalan arm was not evaluable for the outcome measure.
reporting Status
POSTED
time Frame
Through date of discharge (up to be 18 days)
title
Median Daily Dose of Anti-diarrheal Medications
type
SECONDARY
unit Of Measure
number of doses in one day

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

Preserved source evidence · Not medical advice