TriangleNCT01324947 · OUTCOME
Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.
What was measured
Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease.
Analysis population: Intent to Treat includes all participants enrolled
Groups in this outcome
Pomalidomide
Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
| Group | Source count |
|---|---|
| Pomalidomide | 74 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide | 19.0 | Not reported | 14.1 | 27.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.1
- upper Limit
- 27.4
- value
- 19.0
- denoms
- counts
- group Id
- OG000
- value
- 74
- units
- Participants
- description
- Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: * Increase of ≥ 25% from nadir in: * Serum M-component (absolute increase ≥ 0.5 g/dl) * Urine M-component (absolute increase ≥ 200 mg/24 hours) * In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 100 mg/dl) * Bone marrow plasma cell percentage (absolute % ≥ 10%) * Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
- id
- OG000
- title
- Pomalidomide
- param Type
- MEDIAN
- population Description
- Intent to Treat includes all participants enrolled
- reporting Status
- POSTED
- time Frame
- From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.
- title
- Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice