TriangleNCT00511238 · OUTCOME
Duration of Response (A1 Only)
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
- Response assessments same as described in primary outcome measure
What was measured
Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.
Analysis population: Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.
Groups in this outcome
Carfilzomib (A1) for (ORR)
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
Carfilzomib (A1) for (CBR)
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
| Group | Source count |
|---|---|
| Carfilzomib (A1) for (ORR) | 61 |
| Carfilzomib (A1) for (CBR) | 95 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib (A1) for (ORR) | 7.8 | Not reported | 5.6 | 9.2 | Not reported |
| Carfilzomib (A1) for (CBR) | 8.3 | Not reported | 6.5 | 9.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 9.2
- value
- 7.8
- group Id
- OG001
- lower Limit
- 6.5
- upper Limit
- 9.7
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
- id
- OG000
- title
- Carfilzomib (A1) for (ORR)
- description
- In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
- id
- OG001
- title
- Carfilzomib (A1) for (CBR)
- param Type
- MEDIAN
- population Description
- Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See overall analysis population description of response-evaluable population above.
- reporting Status
- POSTED
- time Frame
- Response assessments same as described in primary outcome measure
- title
- Duration of Response (A1 Only)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice