TriangleNCT00680992 · OUTCOME
Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).
What was measured
Time to disease progression or recurrence during the on-study period was defined as the time interval (in days) from the date of first dose of study drug to the date of earliest Progressive Disease (PD) during the initial treatment phase. PD was defined as the response of progressive disease, locally recurrent disease or relapse as captured in the Disease Status page of the Case Report Form. If a participant had not had PD by the end of the initial treatment phase date, time to disease progression or recurrence were censored at her/his end of initial treatment phase date. Since median time to disease progression or recurrence for participants in cohort 1 was not reached, Kaplan-Meier estimates for the probability (expressed as a percentage) of participants in cohort 1 to have disease progression or recurrence at months 6, 12, 24, 36 and 60 are presented.
Analysis population: The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 1 only.
Groups in this outcome
Cohort 1 (Denosumab 120 mg Q4W)
Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
| Group | Source count |
|---|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 260 |
Reported measurements
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 1.9 | Not reported | 0.3 | 3.6 | Not reported |
Month 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 4.3 | Not reported | 1.8 | 6.8 | Not reported |
Month 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 6.1 | Not reported | 3.1 | 9.0 | Not reported |
Month 36
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 8.2 | Not reported | 4.6 | 11.8 | Not reported |
Month 60
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Denosumab 120 mg Q4W) | 11.7 | Not reported | 7.1 | 16.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.3
- upper Limit
- 3.6
- value
- 1.9
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 6.8
- value
- 4.3
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.1
- upper Limit
- 9.0
- value
- 6.1
- title
- Month 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 11.8
- value
- 8.2
- title
- Month 36
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- 16.2
- value
- 11.7
- title
- Month 60
- denoms
- counts
- group Id
- OG000
- value
- 260
- units
- Participants
- description
- Time to disease progression or recurrence during the on-study period was defined as the time interval (in days) from the date of first dose of study drug to the date of earliest Progressive Disease (PD) during the initial treatment phase. PD was defined as the response of progressive disease, locally recurrent disease or relapse as captured in the Disease Status page of the Case Report Form. If a participant had not had PD by the end of the initial treatment phase date, time to disease progression or recurrence were censored at her/his end of initial treatment phase date. Since median time to disease progression or recurrence for participants in cohort 1 was not reached, Kaplan-Meier estimates for the probability (expressed as a percentage) of participants in cohort 1 to have disease progression or recurrence at months 6, 12, 24, 36 and 60 are presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- id
- OG000
- title
- Cohort 1 (Denosumab 120 mg Q4W)
- param Type
- NUMBER
- population Description
- The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 1 only.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months).
- title
- Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability
- type
- SECONDARY
- unit Of Measure
- Percent probability
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice