TriangleNCT02739594 · OUTCOME
Number of SREs for Each Participant
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- SREs
- Interval / dispersion
- Standard Deviation
- Time frame
- From Baseline to end of study (up to Week 96)
What was measured
SREs were defined according to the Bondronat 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 number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.
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 | 0.3 | 0.6 | Not reported | Not reported | Not reported |
| Zoledronate | 0.5 | 1.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.6
- value
- 0.3
- group Id
- OG001
- spread
- 1.1
- value
- 0.5
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- SREs were defined according to the Bondronat 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 number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.
- 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.
- reporting Status
- POSTED
- time Frame
- From Baseline to end of study (up to Week 96)
- title
- Number of SREs for Each Participant
- type
- SECONDARY
- unit Of Measure
- SREs
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice