TriangleNCT00555906 · OUTCOME
Overall Survival (OS): Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib
What was measured
OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date unavailable\] minus the date of first dose of study medication plus 1) divided by 30.44.
Analysis population: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
Groups in this outcome
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
| Group | Source count |
|---|---|
| Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B) | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B) | 21.1 | Not reported | 11.8 | NA | Upper limit of confidence interval could not be estimated since majority of the participants were alive at the time of analysis. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of confidence interval could not be estimated since majority of the participants were alive at the time of analysis.
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- NA
- value
- 21.1
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date unavailable\] minus the date of first dose of study medication plus 1) divided by 30.44.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
- id
- OG000
- title
- Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
- param Type
- MEDIAN
- population Description
- RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclib
- title
- Overall Survival (OS): Phase 2
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice