TriangleNCT01125293 · OUTCOME
2-year Time-to-progression Probability (TTP) [Phase II]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent probability of progression
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Patients were assessed for disease every cycle while on treatment (168 days) and every three months while on maintenance therapy. In long-term follow-up, disease was monitored every 3 months. Study cohort median (range) follow-up was 15 (1 - 23) months.
What was measured
2-year TTP probability is based on Kaplan-Meier methods. TTP is defined as time from enrollment to the date of progressive disease (PD). PD is defined as ≥25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable the disease. Patients without PD and not reporting use of non-protocol therapy prior to PD are censored at date of last objective progression-free disease assessment. Patients reporting use of non-protocol therapy prior to PD are censored at date of last objective progression-free disease assessment date prior to post-discontinuation therapy.
Groups in this outcome
Phase II
Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
| Group | Source count |
|---|---|
| Phase II | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II | 28 | Not reported | 5 | 57 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 57
- value
- 28
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- 2-year TTP probability is based on Kaplan-Meier methods. TTP is defined as time from enrollment to the date of progressive disease (PD). PD is defined as ≥25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable the disease. Patients without PD and not reporting use of non-protocol therapy prior to PD are censored at date of last objective progression-free disease assessment. Patients reporting use of non-protocol therapy prior to PD are censored at date of last objective progression-free disease assessment date prior to post-discontinuation therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Combination of everolimus \& rituximab with bortezomib for 6 cycles Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
- id
- OG000
- title
- Phase II
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Patients were assessed for disease every cycle while on treatment (168 days) and every three months while on maintenance therapy. In long-term follow-up, disease was monitored every 3 months. Study cohort median (range) follow-up was 15 (1 - 23) months.
- title
- 2-year Time-to-progression Probability (TTP) [Phase II]
- type
- SECONDARY
- unit Of Measure
- percent probability of progression
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Preserved source evidence · Not medical advice