TriangleNCT02739594 · OUTCOME
Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and Weeks 44, 92
What was measured
Elevation in SCr was defined as an increase greater than (\>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (\<) 1.4 mg/dL, or an increase \>1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.
Analysis population: ITT Population.
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
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | 2.4 | Not reported | 0.1 | 12.9 | Not reported |
| Zoledronate | 2.5 | Not reported | 0.1 | 13.2 | Not reported |
Week 92
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | 7.3 | Not reported | 1.5 | 19.9 | Not reported |
| Zoledronate | 2.5 | Not reported | 0.1 | 13.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 12.9
- value
- 2.4
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 13.2
- value
- 2.5
- title
- Week 44
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 19.9
- value
- 7.3
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 13.2
- value
- 2.5
- title
- Week 92
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Elevation in SCr was defined as an increase greater than (\>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (\<) 1.4 mg/dL, or an increase \>1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- ITT Population.
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 44, 92
- title
- Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice