TriangleNCT00908232 · OUTCOME
One Year Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year
What was measured
Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.
Analysis population: mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
Groups in this outcome
Complete to Partial Response: Bortezomib + Dexamethasone
Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
Stable Disease After 4 Cycles: VD, VDC, VDL
Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
| Group | Source count |
|---|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | 144 |
| Stable Disease After 4 Cycles: VD, VDC, VDL | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Complete to Partial Response: Bortezomib + Dexamethasone | 80 | Not reported | 73 | 87 | Not reported |
| Stable Disease After 4 Cycles: VD, VDC, VDL | 89 | Not reported | 62 | 97 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73
- upper Limit
- 87
- value
- 80
- group Id
- OG001
- lower Limit
- 62
- upper Limit
- 97
- value
- 89
- denoms
- counts
- group Id
- OG000
- value
- 144
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
- id
- OG000
- title
- Complete to Partial Response: Bortezomib + Dexamethasone
- description
- Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
- id
- OG001
- title
- Stable Disease After 4 Cycles: VD, VDC, VDL
- param Type
- NUMBER
- population Description
- mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).
- reporting Status
- POSTED
- time Frame
- At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year
- title
- One Year Survival
- type
- SECONDARY
- unit Of Measure
- percent probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice