TriangleNCT00148317 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)
What was measured
Response was assessed using IMWG guidelines, which for progressive disease are as follows: Increase of \> 25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)\* * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is \> 5g/dL, then absolute increase of 1g is sufficient for progression.
Groups in this outcome
Treatment Arm (All Patients)
Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
| Group | Source count |
|---|---|
| Treatment Arm (All Patients) | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm (All Patients) | 46.6 | Not reported | 6.4 | 68.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 68.8
- value
- 46.6
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Response was assessed using IMWG guidelines, which for progressive disease are as follows: Increase of \> 25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)\* * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is \> 5g/dL, then absolute increase of 1g is sufficient for progression.
- dispersion Type
- Full Range
- groups
- description
- Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
- id
- OG000
- title
- Treatment Arm (All Patients)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Date of progression, assessed from start of trial to Final data cut off date (15 April 2011)
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice