TriangleNCT02902965 · OUTCOME
Progression Free Survival (PFS) at Landmark Points - 20 Months
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
- The median time on study was 19.6 months (range: 0.16+, 24.64), with the 20 month Progression-Free Survival (PFS) rate presented based on Kaplan-Meier estimates.
What was measured
PFS at landmark points are the percentage of participants without progression (i.e., KM estimates) at the landmark time endpoints.
Groups in this outcome
Ibrutinib+ Bortezomib+ Dexamethasone
Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
| Group | Source count |
|---|---|
| Ibrutinib+ Bortezomib+ Dexamethasone | 74 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib+ Bortezomib+ Dexamethasone | 6.6 | Not reported | 1.6 | 16.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.9
- estimate Comment
- Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- param Type
- PFS rate
- param Value
- 6.6
Complete source fields
- analyses
- ci Lower Limit
- 1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.9
- estimate Comment
- Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- param Type
- PFS rate
- param Value
- 6.6
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.6
- upper Limit
- 16.9
- value
- 6.6
- denoms
- counts
- group Id
- OG000
- value
- 74
- units
- Participants
- description
- PFS at landmark points are the percentage of participants without progression (i.e., KM estimates) at the landmark time endpoints.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
- id
- OG000
- title
- Ibrutinib+ Bortezomib+ Dexamethasone
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- The median time on study was 19.6 months (range: 0.16+, 24.64), with the 20 month Progression-Free Survival (PFS) rate presented based on Kaplan-Meier estimates.
- title
- Progression Free Survival (PFS) at Landmark Points - 20 Months
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice