TriangleNCT02739594 · OUTCOME
Percentage of Participants With Skeletal-Related Events (SREs)
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
- From Baseline to end of study (up to Week 96)
What was measured
SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibandronate | 22.0 | Not reported | 10.6 | 37.6 | Not reported |
| Zoledronate | 30.0 | Not reported | 16.6 | 46.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.6
- upper Limit
- 37.6
- value
- 22.0
- group Id
- OG001
- lower Limit
- 16.6
- upper Limit
- 46.5
- value
- 30.0
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study 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
- From Baseline to end of study (up to Week 96)
- title
- Percentage of Participants With Skeletal-Related Events (SREs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice