TriangleNCT01286077 · OUTCOME
Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to end of study (approximately 4 years 7 months)
What was measured
Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of \>=25% from lowest response level in any one or more of the following: serum M protein (absolute increase \>=0.5 g/dl)c or urine M protein (absolute increase \>=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase \>10 mg/dL; or % bone marrow plasma cells: absolute value \>=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Analysis population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
Groups in this outcome
Bortezomib
bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
Non-treated Control
no treatment, observation only
| Group | Source count |
|---|---|
| Bortezomib | 46 |
| Non-treated Control | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | 6.5 | 1.48 | Not reported | Not reported | Not reported |
| Non-treated Control | 19.1 | 1.26 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.48
- value
- 6.5
- group Id
- OG001
- spread
- 1.26
- value
- 19.1
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 47
- units
- Participants
- description
- Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of \>=25% from lowest response level in any one or more of the following: serum M protein (absolute increase \>=0.5 g/dl)c or urine M protein (absolute increase \>=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase \>10 mg/dL; or % bone marrow plasma cells: absolute value \>=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
- groups
- description
- bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
- id
- OG000
- title
- Bortezomib
- description
- no treatment, observation only
- id
- OG001
- title
- Non-treated Control
- param Type
- NUMBER
- population Description
- FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. "N" (number of subjects analyzed) signifies the subjects evaluable this measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of study (approximately 4 years 7 months)
- title
- Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice