TriangleNCT02331368 · OUTCOME
The Estimated Percentage of Patients Alive Without Relapse or Progression at 2 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 Years
What was measured
Progression is defined as an increase of ≥ 25% from the lowest response value in any one or more of the following: Serum M-component with an absolute increase ≥ 0.5 g/dL; and/or Urine M-component with an absolute increase ≥ 200 mg/24 hours; and/or Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100mg/l) Bone marrow plasma cell percentage (absolute % 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 hypercalcemia (corrected serum calcium \>11.5mg/100ml) that can be attributed solely to the plasma cell proliferative disorder
Analysis population: 32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation and were included in primary endpoint analysis.
Groups in this outcome
Anti-PD-1 (MK-3475)
Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
| Group | Source count |
|---|---|
| Anti-PD-1 (MK-3475) | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Anti-PD-1 (MK-3475) | 83 | Not reported | 68 | 100 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 68
- upper Limit
- 100
- value
- 83
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- Progression is defined as an increase of ≥ 25% from the lowest response value in any one or more of the following: Serum M-component with an absolute increase ≥ 0.5 g/dL; and/or Urine M-component with an absolute increase ≥ 200 mg/24 hours; and/or Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \>100mg/l) Bone marrow plasma cell percentage (absolute % 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 hypercalcemia (corrected serum calcium \>11.5mg/100ml) that can be attributed solely to the plasma cell proliferative disorder
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Study Treatment: 200 mg/day of MK-3475 administered every 3 weeks, starting day +14 post-transplant for a total of 9 doses.
- id
- OG000
- title
- Anti-PD-1 (MK-3475)
- param Type
- NUMBER
- population Description
- 32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation and were included in primary endpoint analysis.
- reporting Status
- POSTED
- time Frame
- 2 Years
- title
- The Estimated Percentage of Patients Alive Without Relapse or Progression at 2 Years
- type
- SECONDARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice