Change in Enterocolitis as Assessed Per CTCAE v5.0
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
MEAN
Unit
CTCAE grade
Interval / dispersion
Standard Deviation
Time frame
From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
What was measured
Grade 0 enterocolitis is defined as no enterocolitis. Grade 1 enterocolitis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 enterocolitis is defined as abdominal pain; mucus or blood in stool. Grade 3 enterocolitis is defined as severe or persistent abdominal pain; fever; ileus; peritoneal signs. Grade 4 enterocolitis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 enterocolitis is defined as death.
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
26
Placebo + Standard of Care Melphalan
24
Reported measurements
Day -3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Day -2
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Day -1
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Day 0
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Day 1
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.08
0.27
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.04
0.20
Not reported
Not reported
Not reported
Day 2
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.04
0.20
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.08
0.41
Not reported
Not reported
Not reported
Day 3
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Day 4
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.04
0.20
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.04
0.20
Not reported
Not reported
Not reported
Day 5
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.04
0.20
Not reported
Not reported
Not reported
Day 6
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.08
0.28
Not reported
Not reported
Not reported
Day 7
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.12
0.33
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.08
0.28
Not reported
Not reported
Not reported
Day 8
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.27
0.67
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.25
0.61
Not reported
Not reported
Not reported
Day 9
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.27
0.60
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.38
0.61
Not reported
Not reported
Not reported
Day 10
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.23
0.59
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.38
0.82
Not reported
Not reported
Not reported
Day 11
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.12
0.43
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.25
0.61
Not reported
Not reported
Not reported
Day 12
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
24
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.08
0.39
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.25
0.61
Not reported
Not reported
Not reported
Day 13
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
26
Placebo + Standard of Care Melphalan
23
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.04
0.20
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.13
0.34
Not reported
Not reported
Not reported
Day 14
Analysis denominator · Participants
Group
Source count
Uproleselan + Standard of Care Melphalan
25
Placebo + Standard of Care Melphalan
22
Values in CTCAE grade · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Uproleselan + Standard of Care Melphalan
0.00
0.00
Not reported
Not reported
Not reported
Placebo + Standard of Care Melphalan
0.05
0.21
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.00
value
0.00
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
24
units
Participants
title
Day -3
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.00
value
0.00
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day -2
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.00
value
0.00
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day -1
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.00
value
0.00
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 0
categories
measurements
group Id
OG000
spread
0.27
value
0.08
group Id
OG001
spread
0.20
value
0.04
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 1
categories
measurements
group Id
OG000
spread
0.20
value
0.04
group Id
OG001
spread
0.41
value
0.08
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 2
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.00
value
0.00
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 3
categories
measurements
group Id
OG000
spread
0.20
value
0.04
group Id
OG001
spread
0.20
value
0.04
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 4
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.20
value
0.04
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 5
categories
measurements
group Id
OG000
spread
0.00
value
0.00
group Id
OG001
spread
0.28
value
0.08
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 6
categories
measurements
group Id
OG000
spread
0.33
value
0.12
group Id
OG001
spread
0.28
value
0.08
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 7
categories
measurements
group Id
OG000
spread
0.67
value
0.27
group Id
OG001
spread
0.61
value
0.25
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
title
Day 8
denoms
counts
group Id
OG000
value
26
group Id
OG001
value
24
units
Participants
description
Grade 0 enterocolitis is defined as no enterocolitis. Grade 1 enterocolitis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 enterocolitis is defined as abdominal pain; mucus or blood in stool. Grade 3 enterocolitis is defined as severe or persistent abdominal pain; fever; ileus; peritoneal signs. Grade 4 enterocolitis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 enterocolitis is defined as death.
dispersion Type
Standard Deviation
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
MEAN
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
From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
title
Change in Enterocolitis as Assessed Per CTCAE v5.0
Triangle