TriangleNCT00869206 · OUTCOME
Average ECOG Performance Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- from baseline up to 2 years
What was measured
To compare functional status (ECOG performance status) 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 change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm.
Analysis population: 1766 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) | 882 |
| Arm II (Zoledronic Acid Every 12 Weeks) | 884 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Zoledronic Acid Every 4 Weeks) | 0.82 | 0.042 | Not reported | Not reported | Not reported |
| Arm II (Zoledronic Acid Every 12 Weeks) | 0.84 | 0.042 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.0034
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.64
- param Type
- Slope
- param Value
- 0.0016
- statistical Comment
- Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.0034
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.64
- param Type
- Slope
- param Value
- 0.0016
- statistical Comment
- Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.042
- value
- 0.82
- group Id
- OG001
- spread
- 0.042
- value
- 0.84
- denoms
- counts
- group Id
- OG000
- value
- 882
- group Id
- OG001
- value
- 884
- units
- Participants
- description
- To compare functional status (ECOG performance status) 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 change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm.
- dispersion Type
- Standard Error
- 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
- MEAN
- population Description
- 1766 patients completed treatment and were analyzed.
- reporting Status
- POSTED
- time Frame
- from baseline up to 2 years
- title
- Average ECOG Performance Status
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice