TriangleNCT02739594 · OUTCOME
Percent Change From Baseline in CrCl
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
- Baseline and Weeks 44, 92
What was measured
CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as \[Week 44 or 92 CrCl minus Baseline CrCl\] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
Analysis population: ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table.
Groups in this outcome
Ibandronate
Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
Zoledronate
Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
| Group | Source count |
|---|---|
| Ibandronate | 41 |
| Zoledronate | 40 |
Reported measurements
Week 44, Calculated/Blood (n=41,40)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | -0.5 | 28.5 | Not reported | Not reported | Not reported |
| Zoledronate | -0.4 | 21.7 | Not reported | Not reported | Not reported |
Week 44, Measured/Urinalysis (n=37,37)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | 6.9 | 53.0 | Not reported | Not reported | Not reported |
| Zoledronate | 3.9 | 37.3 | Not reported | Not reported | Not reported |
Week 92, Calculated/Blood (n=41,40)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | -0.7 | 31.9 | Not reported | Not reported | Not reported |
| Zoledronate | -4.3 | 20.3 | Not reported | Not reported | Not reported |
Week 92, Measured/Urinalysis (n=37,37)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | 3.1 | 45.6 | Not reported | Not reported | Not reported |
| Zoledronate | 2.0 | 39.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 28.5
- value
- -0.5
- group Id
- OG001
- spread
- 21.7
- value
- -0.4
- title
- Week 44, Calculated/Blood (n=41,40)
- categories
- measurements
- group Id
- OG000
- spread
- 53.0
- value
- 6.9
- group Id
- OG001
- spread
- 37.3
- value
- 3.9
- title
- Week 44, Measured/Urinalysis (n=37,37)
- categories
- measurements
- group Id
- OG000
- spread
- 31.9
- value
- -0.7
- group Id
- OG001
- spread
- 20.3
- value
- -4.3
- title
- Week 92, Calculated/Blood (n=41,40)
- categories
- measurements
- group Id
- OG000
- spread
- 45.6
- value
- 3.1
- group Id
- OG001
- spread
- 39.1
- value
- 2.0
- title
- Week 92, Measured/Urinalysis (n=37,37)
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as \[Week 44 or 92 CrCl minus Baseline CrCl\] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
- id
- OG000
- title
- Ibandronate
- description
- Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
- id
- OG001
- title
- Zoledronate
- param Type
- MEAN
- population Description
- ITT Population. The "Number of Participants Analyzed" reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table.
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 44, 92
- title
- Percent Change From Baseline in CrCl
- type
- SECONDARY
- unit Of Measure
- percent change
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice