TriangleNCT00869206 · OUTCOME
Incidence of Renal Dysfunction
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
- Not reported
- Time frame
- from baseline up to 2 years
What was measured
To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here.
Analysis population: 1689 patients completed treatment and were analyzed.
Groups in this outcome
Arm I (Zoledronic Acid Every 4 Weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Arm II (Zoledronic Acid Every 12 Weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (Zoledronic Acid Every 4 Weeks) | 852 |
| Arm II (Zoledronic Acid Every 12 Weeks) | 837 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Zoledronic Acid Every 4 Weeks) | 1.2 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Zoledronic Acid Every 12 Weeks) | .5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.7
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.10
- param Type
- Mean Difference (Final Values)
- param Value
- 0.7
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -0.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.7
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.10
- param Type
- Mean Difference (Final Values)
- param Value
- 0.7
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.2
- group Id
- OG001
- value
- .5
- denoms
- counts
- group Id
- OG000
- value
- 852
- group Id
- OG001
- value
- 837
- units
- Participants
- description
- To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here.
- groups
- description
- Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (Zoledronic Acid Every 4 Weeks)
- description
- Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II (Zoledronic Acid Every 12 Weeks)
- param Type
- NUMBER
- population Description
- 1689 patients completed treatment and were analyzed.
- reporting Status
- POSTED
- time Frame
- from baseline up to 2 years
- title
- Incidence of Renal Dysfunction
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice