NCT00747123 · OUTCOME
Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)
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
- Percent change
- Interval / dispersion
- Standard Deviation
- Time frame
- From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
What was measured
The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation.
Analysis population: All treated participants who had at least 1 postdosing measurement
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 | 7 |
|---|
Reported measurements
Day 29
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 | 7 |
|---|
Values in Percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -6.0 | 12.25 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -9.4 | 22.60 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | -5.8 | 25.03 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | -6.4 | 23.87 | 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 Percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -7.2 | 6.77 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -8.0 | 26.09 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | -11.0 | 33.87 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | -11.6 | 26.34 | 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 Percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -4.5 | 3.78 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -12.7 | 23.08 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | -10.5 | 37.50 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | -11.1 | 28.79 | 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 Percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -3.5 | 4.46 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -13.7 | 25.03 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | -12.3 | 38.04 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | -11.4 | 29.43 | Not reported | Not reported | Not reported |
|---|
Day 141
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 Percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.7 | 13.05 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -13.7 | 25.26 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | -15.0 | 37.33 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | -12.1 | 32.79 | Not reported | Not reported | Not reported |
|---|
Day 169
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 Percent change · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -3.0 | 7.59 | Not reported | Not reported | Not reported |
|---|
| 0.1 mg/kg ACE 011 | -14.7 | 24.59 | Not reported | Not reported | Not reported |
|---|
| 0.3 mg/kg ACE 011 | -15.0 | 38.40 | Not reported | Not reported | Not reported |
|---|
| 0.5 mg/kg ACE 011 | -13.6 | 30.36 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.25
- value
- -6.0
- group Id
- OG001
- spread
- 22.60
- value
- -9.4
- group Id
- OG002
- spread
- 25.03
- value
- -5.8
- group Id
- OG003
- spread
- 23.87
- value
- -6.4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 29
- categories
- measurements
- group Id
- OG000
- spread
- 6.77
- value
- -7.2
- group Id
- OG001
- spread
- 26.09
- value
- -8.0
- group Id
- OG002
- spread
- 33.87
- value
- -11.0
- group Id
- OG003
- spread
- 26.34
- value
- -11.6
- 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
- 3.78
- value
- -4.5
- group Id
- OG001
- spread
- 23.08
- value
- -12.7
- group Id
- OG002
- spread
- 37.50
- value
- -10.5
- group Id
- OG003
- spread
- 28.79
- value
- -11.1
- 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
- 4.46
- value
- -3.5
- group Id
- OG001
- spread
- 25.03
- value
- -13.7
- group Id
- OG002
- spread
- 38.04
- value
- -12.3
- group Id
- OG003
- spread
- 29.43
- value
- -11.4
- 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
- 13.05
- value
- 0.7
- group Id
- OG001
- spread
- 25.26
- value
- -13.7
- group Id
- OG002
- spread
- 37.33
- value
- -15.0
- group Id
- OG003
- spread
- 32.79
- value
- -12.1
- 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 141
- categories
- measurements
- group Id
- OG000
- spread
- 7.59
- value
- -3.0
- group Id
- OG001
- spread
- 24.59
- value
- -14.7
- group Id
- OG002
- spread
- 38.40
- value
- -15.0
- group Id
- OG003
- spread
- 30.36
- value
- -13.6
- 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
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- The visual analog scale (VAS) is a pain rating scale. Scores are based on the percent change from baseline (Day 1) in self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain. The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions. In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation.
- 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 treated participants who had at least 1 postdosing measurement
- reporting Status
- POSTED
- time Frame
- From baseline (Day 1) to Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
- title
- Percent Change From Baseline in Bone Pain Visual Analog Scale (VAS)
- type
- SECONDARY
- unit Of Measure
- Percent change
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Preserved source evidence · Not medical advice
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