TriangleNCT02119468 · OUTCOME
One-Year Progression-Free Survival at the Recommend Phase II Dose (RP2D)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants (%)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, up to 24 months. And the median follow-up for the surviving patients is at least one year.
What was measured
Progression-free survival (PFS) was defined as time from initial treatment to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\]
Analysis population: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
Groups in this outcome
Dose Level #2 (4mg MLN9708)
Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Dose Level #2 (4mg MLN9708) | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level #2 (4mg MLN9708) | 34 | Not reported | 16 | 53 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16
- upper Limit
- 53
- value
- 34
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Progression-free survival (PFS) was defined as time from initial treatment to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula \[Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.\]
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Dose Level #2 (4mg MLN9708)
- param Type
- NUMBER
- population Description
- Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
- reporting Status
- POSTED
- time Frame
- Date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, up to 24 months. And the median follow-up for the surviving patients is at least one year.
- title
- One-Year Progression-Free Survival at the Recommend Phase II Dose (RP2D)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants (%)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice