TriangleNCT00920855 · OUTCOME
Kaplan-Meier Estimate for Time to Progression (TTP)
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
- up to 8.6 months
What was measured
Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following: * \>25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L), * \>25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h), * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%), * definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, * the development of new bone lesions or soft tissue plasmacytomas, * the development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
Analysis population: Safety population
Groups in this outcome
Bendamustine and Bortezomib - Overall
Bendamustine in escalating doses of 50, 70 or 90 mg/m\^2 as combination therapy with bortezomib at 1.0 mg/m\^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
| Group | Source count |
|---|---|
| Bendamustine and Bortezomib - Overall | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine and Bortezomib - Overall | 8.4 | Not reported | 4.03 | NA | Upper boundary was not estimated due to the limited number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper boundary was not estimated due to the limited number of participants with events.
- group Id
- OG000
- lower Limit
- 4.03
- upper Limit
- NA
- value
- 8.4
- denoms
- counts
- group Id
- OG000
- value
- 40
- units
- Participants
- description
- Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following: * \>25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L), * \>25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h), * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%), * definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, * the development of new bone lesions or soft tissue plasmacytomas, * the development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bendamustine in escalating doses of 50, 70 or 90 mg/m\^2 as combination therapy with bortezomib at 1.0 mg/m\^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
- id
- OG000
- title
- Bendamustine and Bortezomib - Overall
- param Type
- MEDIAN
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- up to 8.6 months
- title
- Kaplan-Meier Estimate for Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice