NCT00747123 · OUTCOME
Change From Baseline in Hemoglobin
A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma · Source last updated 2024-10-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- g/dL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
What was measured
Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement.
Analysis population: All randomized participants
Groups in this outcome
Placebo
Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.
0.1 mg/kg ACE 011
0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
0.3 mg/kg ACE 011
0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)
0.5 mg/kg ACE 011
0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
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 |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 8 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 8 |
|---|
Reported measurements
Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 8 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 8 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.47 | 0.288 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | 0.89 | 1.254 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 0.83 | 0.599 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 0.80 | 0.844 | Not reported | Not reported | Not reported |
|---|
Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 7 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 7 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.50 | 0.607 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -0.91 | 1.844 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 0.66 | 0.457 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 0.96 | 1.648 | Not reported | Not reported | Not reported |
|---|
Day 36
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 8 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 6 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 1.02 | 0.643 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | 0.73 | 1.873 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 1.00 | 0.787 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 1.48 | 1.167 | Not reported | Not reported | Not reported |
|---|
Day 57
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 7 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 7 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.53 | 0.602 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | 0.47 | 1.682 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 1.09 | 1.022 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 1.00 | 1.22 | Not reported | Not reported | Not reported |
|---|
Day 85
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 7 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 7 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.78 | 0.958 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | 0.57 | 0.907 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 0.86 | 1.323 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 1.56 | 0.704 | Not reported | Not reported | Not reported |
|---|
Day 113
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 6 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 7 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.33 | 0.789 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | 0.53 | 1.141 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 0.96 | 1.620 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 0.97 | 1.024 | Not reported | Not reported | Not reported |
|---|
Day 169/Early Termination
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 6 |
|---|
| 0.1 mg/kg ACE 011 | 6 |
|---|
| 0.3 mg/kg ACE 011 | 8 |
|---|
| 0.5 mg/kg ACE 011 | 7 |
|---|
Values in g/dL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.13 | 1.140 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | 0.57 | 1.500 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | 0.33 | 1.763 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | 0.03 | 2.392 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.288
- value
- 0.47
- group Id
- OG001
- spread
- 1.254
- value
- 0.89
- group Id
- OG002
- spread
- 0.599
- value
- 0.83
- group Id
- OG003
- spread
- 0.844
- value
- 0.80
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 8
- units
- Participants
- title
- Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 0.607
- value
- 0.50
- group Id
- OG001
- spread
- 1.844
- value
- -0.91
- group Id
- OG002
- spread
- 0.457
- value
- 0.66
- group Id
- OG003
- spread
- 1.648
- value
- 0.96
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 29
- categories
- measurements
- group Id
- OG000
- spread
- 0.643
- value
- 1.02
- group Id
- OG001
- spread
- 1.873
- value
- 0.73
- group Id
- OG002
- spread
- 0.787
- value
- 1.00
- group Id
- OG003
- spread
- 1.167
- value
- 1.48
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- Day 36
- categories
- measurements
- group Id
- OG000
- spread
- 0.602
- value
- 0.53
- group Id
- OG001
- spread
- 1.682
- value
- 0.47
- group Id
- OG002
- spread
- 1.022
- value
- 1.09
- group Id
- OG003
- spread
- 1.22
- value
- 1.00
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 57
- categories
- measurements
- group Id
- OG000
- spread
- 0.958
- value
- 0.78
- group Id
- OG001
- spread
- 0.907
- value
- 0.57
- group Id
- OG002
- spread
- 1.323
- value
- 0.86
- group Id
- OG003
- spread
- 0.704
- value
- 1.56
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 85
- categories
- measurements
- group Id
- OG000
- spread
- 0.789
- value
- 0.33
- group Id
- OG001
- spread
- 1.141
- value
- 0.53
- group Id
- OG002
- spread
- 1.620
- value
- 0.96
- group Id
- OG003
- spread
- 1.024
- value
- 0.97
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 113
- categories
- measurements
- group Id
- OG000
- spread
- 1.140
- value
- 0.13
- group Id
- OG001
- spread
- 1.500
- value
- 0.57
- group Id
- OG002
- spread
- 1.763
- value
- 0.33
- group Id
- OG003
- spread
- 2.392
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 169/Early Termination
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 8
- units
- Participants
- description
- Summary of the change from baseline in hemoglobin (g/dL) by the pre-specified timepoints. Baseline was defined as the last measurement prior to dosing. Data were summarized for all treated participants who had at least 1 postdosing measurement.
- dispersion Type
- Standard Deviation
- groups
- description
- Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.
- id
- OG000
- title
- Placebo
- description
- 0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
- id
- OG001
- title
- 0.1 mg/kg ACE 011
- description
- 0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)
- id
- OG002
- title
- 0.3 mg/kg ACE 011
- description
- 0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
- id
- OG003
- title
- 0.5 mg/kg ACE 011
- param Type
- MEAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Day 1 (baseline), Day 8, Day 29, Day 36, Day 57, Day 85, Day 113, Day 169
- title
- Change From Baseline in Hemoglobin
- type
- PRIMARY
- unit Of Measure
- g/dL
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