NCT04582539 · OUTCOME
Change From Baseline in Ferritin
To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma · Source last updated 2025-10-22
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanograms per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycles 2, 3, 4, 5, 6, and 7 Day 1
What was measured
Change from Baseline (CFB) was calculated as the post-Baseline value minus the Baseline value.
Analysis population: Full Analysis Set-MDS. Only participants with available data were analyzed.
Groups in this outcome
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
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 |
|---|
| Zilurgisertib 50 mg QD | 4 |
|---|
| Zilurgisertib 100 mg QD | 5 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 5 |
|---|
| Zilurgisertib 600 mg QD | 3 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 4 |
|---|
| Zilurgisertib 100 mg QD | 5 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 5 |
|---|
| Zilurgisertib 600 mg QD | 3 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 1022.35 | 634.096 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | 930.18 | 697.078 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 2092.25 | 1220.166 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | 2034.42 | 1329.794 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | 1469.00 | 1191.873 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 1 Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 3 |
|---|
| Zilurgisertib 100 mg QD | 5 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 3 |
|---|
| Zilurgisertib 600 mg QD | 2 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 47.67 | 43.501 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | -65.24 | 57.388 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 203.25 | 523.789 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | -98.83 | 567.584 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | -110.00 | 24.042 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 2 |
|---|
| Zilurgisertib 100 mg QD | 3 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 3 |
|---|
| Zilurgisertib 600 mg QD | 2 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 292.00 | 161.220 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | 17.30 | 31.109 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 67.50 | 140.950 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | -109.77 | 98.223 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | -96.00 | 56.569 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 4 |
|---|
| Zilurgisertib 100 mg QD | 3 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 3 |
|---|
| Zilurgisertib 600 mg QD | 2 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 101.65 | 245.814 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | 70.03 | 76.619 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 154.50 | 453.658 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | -92.87 | 364.312 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | 135.00 | 200.818 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 4 |
|---|
| Zilurgisertib 100 mg QD | 3 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 3 |
|---|
| Zilurgisertib 600 mg QD | 3 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 307.58 | 709.602 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | -6.70 | 46.054 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 532.00 | 833.804 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | 353.77 | 314.682 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | -383.00 | 536.324 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 4 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 3 |
|---|
| Zilurgisertib 100 mg QD | 2 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 5 |
|---|
| Zilurgisertib 600 mg QD | 2 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 409.83 | 689.052 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | -21.15 | 48.295 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 875.00 | 649.850 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | 619.00 | 275.281 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | -153.50 | 82.731 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 3 |
|---|
| Zilurgisertib 100 mg QD | 1 |
|---|
| Zilurgisertib 200 mg QD | 4 |
|---|
| Zilurgisertib 400 mg QD | 4 |
|---|
| Zilurgisertib 600 mg QD | 2 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 349.00 | 680.559 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | 172.00 | NA | Not reported | Not reported | Standard deviation was not calculated for a single participant. |
|---|
| Zilurgisertib 200 mg QD | 574.00 | 394.335 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | 516.10 | 502.323 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 600 mg QD | -106.50 | 211.425 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 6 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 3 |
|---|
| Zilurgisertib 100 mg QD | 2 |
|---|
| Zilurgisertib 200 mg QD | 3 |
|---|
| Zilurgisertib 400 mg QD | 2 |
|---|
| Zilurgisertib 600 mg QD | 0 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 297.67 | 614.180 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | 488.50 | 152.028 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 200 mg QD | 347.33 | 362.417 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | 442.15 | 264.246 | Not reported | Not reported | Not reported |
|---|
CFB at Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Zilurgisertib 50 mg QD | 2 |
|---|
| Zilurgisertib 100 mg QD | 1 |
|---|
| Zilurgisertib 200 mg QD | 3 |
|---|
| Zilurgisertib 400 mg QD | 2 |
|---|
| Zilurgisertib 600 mg QD | 0 |
|---|
Values in nanograms per milliliter · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zilurgisertib 50 mg QD | 365.50 | 658.316 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 100 mg QD | 971.00 | NA | Not reported | Not reported | Standard deviation was not calculated for a single participant. |
|---|
| Zilurgisertib 200 mg QD | 315.33 | 222.172 | Not reported | Not reported | Not reported |
|---|
| Zilurgisertib 400 mg QD | 507.35 | 64.559 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 634.096
- value
- 1022.35
- group Id
- OG001
- spread
- 697.078
- value
- 930.18
- group Id
- OG002
- spread
- 1220.166
- value
- 2092.25
- group Id
- OG003
- spread
- 1329.794
- value
- 2034.42
- group Id
- OG004
- spread
- 1191.873
- value
- 1469.00
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 43.501
- value
- 47.67
- group Id
- OG001
- spread
- 57.388
- value
- -65.24
- group Id
- OG002
- spread
- 523.789
- value
- 203.25
- group Id
- OG003
- spread
- 567.584
- value
- -98.83
- group Id
- OG004
- spread
- 24.042
- value
- -110.00
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- CFB at Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 161.220
- value
- 292.00
- group Id
- OG001
- spread
- 31.109
- value
- 17.30
- group Id
- OG002
- spread
- 140.950
- value
- 67.50
- group Id
- OG003
- spread
- 98.223
- value
- -109.77
- group Id
- OG004
- spread
- 56.569
- value
- -96.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- CFB at Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 245.814
- value
- 101.65
- group Id
- OG001
- spread
- 76.619
- value
- 70.03
- group Id
- OG002
- spread
- 453.658
- value
- 154.50
- group Id
- OG003
- spread
- 364.312
- value
- -92.87
- group Id
- OG004
- spread
- 200.818
- value
- 135.00
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- CFB at Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 709.602
- value
- 307.58
- group Id
- OG001
- spread
- 46.054
- value
- -6.70
- group Id
- OG002
- spread
- 833.804
- value
- 532.00
- group Id
- OG003
- spread
- 314.682
- value
- 353.77
- group Id
- OG004
- spread
- 536.324
- value
- -383.00
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- units
- Participants
- title
- CFB at Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 689.052
- value
- 409.83
- group Id
- OG001
- spread
- 48.295
- value
- -21.15
- group Id
- OG002
- spread
- 649.850
- value
- 875.00
- group Id
- OG003
- spread
- 275.281
- value
- 619.00
- group Id
- OG004
- spread
- 82.731
- value
- -153.50
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- CFB at Cycle 4 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 680.559
- value
- 349.00
- comment
- Standard deviation was not calculated for a single participant.
- group Id
- OG001
- spread
- NA
- value
- 172.00
- group Id
- OG002
- spread
- 394.335
- value
- 574.00
- group Id
- OG003
- spread
- 502.323
- value
- 516.10
- group Id
- OG004
- spread
- 211.425
- value
- -106.50
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- CFB at Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 614.180
- value
- 297.67
- group Id
- OG001
- spread
- 152.028
- value
- 488.50
- group Id
- OG002
- spread
- 362.417
- value
- 347.33
- group Id
- OG003
- spread
- 264.246
- value
- 442.15
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- CFB at Cycle 6 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 658.316
- value
- 365.50
- comment
- Standard deviation was not calculated for a single participant.
- group Id
- OG001
- spread
- NA
- value
- 971.00
- group Id
- OG002
- spread
- 222.172
- value
- 315.33
- group Id
- OG003
- spread
- 64.559
- value
- 507.35
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- CFB at Cycle 7 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- units
- Participants
- description
- Change from Baseline (CFB) was calculated as the post-Baseline value minus the Baseline value.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
- id
- OG000
- title
- Zilurgisertib 50 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
- id
- OG001
- title
- Zilurgisertib 100 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
- id
- OG002
- title
- Zilurgisertib 200 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
- id
- OG003
- title
- Zilurgisertib 400 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
- id
- OG004
- title
- Zilurgisertib 600 mg QD
- param Type
- MEAN
- population Description
- Full Analysis Set-MDS. Only participants with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycles 2, 3, 4, 5, 6, and 7 Day 1
- title
- Change From Baseline in Ferritin
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle