TriangleNCT01782963 · OUTCOME
Median 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
- 95% Confidence Interval
- Time frame
- From the start of treatment until death or progression or until 3 years after the last participant is enrolled
What was measured
The median amount of time as measured from the start of treatment until either death or progression. Progressive disease requires 1 or more of the following: * \>=25% increase from lowest response level in serum M-protein (\>=0.5 g/dL absolute increase) and/or urine M-component (\>=200 mg/24hr absolute increase) * \>=25% increase in the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL). Only for use in patients without measurable serum and M-protein levels. * \>=25% increase in bone marrow plasma cell percentage (absolute percentage \>=10%) * New or increase in existing bone lesions or soft tissue plasmacytomas * Hypercalcemia (serum calcium \>11.5 mg/dL) due solely to the plasma cell proliferative disorder.
Groups in this outcome
Treatment Arm
Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone
| Group | Source count |
|---|---|
| Treatment Arm | 50 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm | 35.1 | Not reported | 30.9 | NA | Upper bound is infinity due to skew of survival data |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper bound is infinity due to skew of survival data
- group Id
- OG000
- lower Limit
- 30.9
- upper Limit
- NA
- value
- 35.1
- denoms
- counts
- group Id
- OG000
- value
- 50
- units
- Participants
- description
- The median amount of time as measured from the start of treatment until either death or progression. Progressive disease requires 1 or more of the following: * \>=25% increase from lowest response level in serum M-protein (\>=0.5 g/dL absolute increase) and/or urine M-component (\>=200 mg/24hr absolute increase) * \>=25% increase in the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL). Only for use in patients without measurable serum and M-protein levels. * \>=25% increase in bone marrow plasma cell percentage (absolute percentage \>=10%) * New or increase in existing bone lesions or soft tissue plasmacytomas * Hypercalcemia (serum calcium \>11.5 mg/dL) due solely to the plasma cell proliferative disorder.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone
- id
- OG000
- title
- Treatment Arm
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From the start of treatment until death or progression or until 3 years after the last participant is enrolled
- title
- Median Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice