TriangleNCT01302392 · OUTCOME
Duration of Response
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
- From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months.
What was measured
Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.
Analysis population: The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of PR or better only.
Groups in this outcome
Best Supportive Care
Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid). Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).
Carfilzomib
Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).
| Group | Source count |
|---|---|
| Best Supportive Care | 18 |
| Carfilzomib | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Best Supportive Care | 9.5 | Not reported | 3.7 | NA | Upper limit of the confidence interval not calculable due to a low number of participants reaching PD or all-cause death. |
| Carfilzomib | 7.2 | Not reported | 4.6 | 12.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of the confidence interval not calculable due to a low number of participants reaching PD or all-cause death.
- group Id
- OG000
- lower Limit
- 3.7
- upper Limit
- NA
- value
- 9.5
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 12.0
- value
- 7.2
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid). Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle).
- id
- OG000
- title
- Best Supportive Care
- description
- Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days \[Days 1, 2, 8, 9, 15, 16\] for individual subjects).
- id
- OG001
- title
- Carfilzomib
- param Type
- MEDIAN
- population Description
- The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of PR or better only.
- reporting Status
- POSTED
- time Frame
- From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months.
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice