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=no symptoms to 5=severe symptoms
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
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Reported measurements
Severity of difficulty swallowing - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
2.00
Not reported
Severity of difficulty swallowing - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
5.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
5.00
Not reported
Severity of difficulty swallowing - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
5.00
Not reported
Severity of mouth or throat sores - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
1.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Severity of mouth or throat sores - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
5.00
Not reported
Severity of mouth or throat sores - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
2.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
5.00
Not reported
Severity of decreased appetite - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Severity of decreased appetite - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
3.00
Not reported
2.00
5.00
Not reported
Placebo + Standard of Care Melphalan
4.00
Not reported
1.00
5.00
Not reported
Severity of decreased appetite - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
3.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
3.00
Not reported
1.00
5.00
Not reported
Severity of nausea - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
2.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Severity of nausea - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
3.00
Not reported
1.00
5.00
Not reported
Placebo + Standard of Care Melphalan
3.50
Not reported
1.00
5.00
Not reported
Severity of nausea - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
22
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
2.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
2.50
Not reported
1.00
5.00
Not reported
Severity of vomiting - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
1.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
2.00
Not reported
Severity of vomiting - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
2.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
2.00
Not reported
1.00
3.00
Not reported
Severity of vomiting - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
2.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
2.00
Not reported
1.00
3.00
Not reported
Severity of heartburn - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Severity of heartburn - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
4.00
Not reported
Severity of heartburn - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.50
Not reported
1.00
4.00
Not reported
Severity of bloating - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Severity of bloating - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
2.00
Not reported
1.00
5.00
Not reported
Placebo + Standard of Care Melphalan
2.00
Not reported
1.00
5.00
Not reported
Severity of bloating - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
2.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.50
Not reported
1.00
3.00
Not reported
Severity of abdominal pain - Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
1.00
Not reported
1.00
2.00
Not reported
Severity of abdominal pain - Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
2.00
Not reported
1.00
4.00
Not reported
Placebo + Standard of Care Melphalan
2.50
Not reported
1.00
4.00
Not reported
Severity of abdominal pain - date of discharge or Day 14 (whichever is sooner)
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
23
Placebo + Standard of Care Melphalan
22
Values in score on a scale · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
1.00
Not reported
1.00
3.00
Not reported
Placebo + Standard of Care Melphalan
2.00
Not reported
1.00
3.00
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
3.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
2.00
value
1.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
24
units
Participants
title
Severity of difficulty swallowing - Day -3
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
5.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
1.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
22
units
Participants
title
Severity of difficulty swallowing - Day 8
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
3.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
1.00
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
22
units
Participants
title
Severity of difficulty swallowing - date of discharge or Day 14 (whichever is sooner)
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
1.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
3.00
value
1.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
24
units
Participants
title
Severity of mouth or throat sores - Day -3
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
4.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
1.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
22
units
Participants
title
Severity of mouth or throat sores - Day 8
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
2.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
1.00
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
22
units
Participants
title
Severity of mouth or throat sores - date of discharge or Day 14 (whichever is sooner)
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
3.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
3.00
value
1.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
24
units
Participants
title
Severity of decreased appetite - Day -3
categories
measurements
group Id
OG000
lower Limit
2.00
upper Limit
5.00
value
3.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
4.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
22
units
Participants
title
Severity of decreased appetite - Day 8
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
4.00
value
3.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
3.00
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
22
units
Participants
title
Severity of decreased appetite - date of discharge or Day 14 (whichever is sooner)
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
2.00
value
1.00
group Id
OG001
lower Limit
1.00
upper Limit
3.00
value
1.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
24
units
Participants
title
Severity of nausea - Day -3
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
5.00
value
3.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
3.50
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
22
units
Participants
title
Severity of nausea - Day 8
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
4.00
value
2.00
group Id
OG001
lower Limit
1.00
upper Limit
5.00
value
2.50
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
22
units
Participants
title
Severity of nausea - date of discharge or Day 14 (whichever is sooner)
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
24
units
Participants
description
* Questions regarding gastrointestinal toxicities
* Responses are scored from 1-5 with 1=no symptoms to 5=severe symptoms
dispersion Type
Full Range
groups
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
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
Triangle