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NCT04682405 · OUTCOME

Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0

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
score on a scale
Interval / dispersion
Full Range
Time frame
Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)

What was measured

* Questions regarding gastrointestinal toxicities * Responses are scored from 1-5 with 1=never and 5=almost constantly

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 Melphalan25
Placebo + Standard of Care Melphalan24

Reported measurements

Frequency of nausea - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.003.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Frequency of nausea - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan4.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan4.00Not reported1.005.00Not reported
Frequency of nausea - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan3.00Not reported1.004.00Not reported
Placebo + Standard of Care Melphalan3.00Not reported1.005.00Not reported
Frequency of vomiting - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.001.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.002.00Not reported
Frequency of vomiting - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.004.00Not reported
Placebo + Standard of Care Melphalan2.50Not reported1.004.00Not reported
Frequency of vomiting - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan21
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.003.00Not reported
Placebo + Standard of Care Melphalan2.00Not reported1.004.00Not reported
Frequency of heartburn - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.003.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Frequency of heartburn - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Frequency of heartburn - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.003.00Not reported
Placebo + Standard of Care Melphalan1.50Not reported1.00400Not reported
Frequency of bloating - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Frequency of bloating - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan2.00Not reported1.005.00Not reported
Frequency of bloating - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan22
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan2.00Not reported1.004.00Not reported
Frequency of diarrhea - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Frequency of diarrhea - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan4.00Not reported3.005.00Not reported
Placebo + Standard of Care Melphalan4.00Not reported2.005.00Not reported
Frequency of diarrhea - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan4.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan4.00Not reported1.005.00Not reported
Frequency of abdominal pain - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.003.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.003.00Not reported
Frequency of abdominal pain - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan2.50Not reported1.005.00Not reported
Frequency of abdominal pain - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.004.00Not reported
Placebo + Standard of Care Melphalan2.00Not reported1.004.00Not reported
Frequency of bowel incontinence - Day -3

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan24
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan1.00Not reported1.003.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.002.00Not reported
Frequency of bowel incontinence - Day 8

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan25
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.004.00Not reported
Placebo + Standard of Care Melphalan1.00Not reported1.004.00Not reported
Frequency of bowel incontinence - date of discharge or Day 14 (whichever is sooner)

Analysis denominator · Participants

GroupSource count
Uproleselan + Standard of Care Melphalan23
Placebo + Standard of Care Melphalan22
Values in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Uproleselan + Standard of Care Melphalan2.00Not reported1.005.00Not reported
Placebo + Standard of Care Melphalan1.50Not reported1.005.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        3.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Frequency of nausea - Day -3
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        5.00
        value
        4.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        5.00
        value
        4.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of nausea - Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        4.00
        value
        3.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        5.00
        value
        3.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of nausea - date of discharge or Day 14 (whichever is sooner)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        1.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        2.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Frequency of vomiting - Day -3
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        4.00
        value
        2.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        2.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of vomiting - Day 8
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        3.00
        value
        2.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        2.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Frequency of vomiting - date of discharge or Day 14 (whichever is sooner)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        3.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Frequency of heartburn - Day -3
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        5.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of heartburn - Day 8
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        3.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        400
        value
        1.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of heartburn - date of discharge or Day 14 (whichever is sooner)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        5.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Frequency of bloating - Day -3
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        5.00
        value
        2.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        5.00
        value
        2.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of bloating - Day 8
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        5.00
        value
        2.00
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.00
        value
        2.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Frequency of bloating - date of discharge or Day 14 (whichever is sooner)
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      24
    units
    Participants
description
* Questions regarding gastrointestinal toxicities * Responses are scored from 1-5 with 1=never and 5=almost constantly
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
Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
title
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice