TriangleNCT01970865 · OUTCOME
Progression-Free Survival (PFS) (Phase 1)
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 start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately)
What was measured
PFS was defined as the time from the first dose of study treatment to the first documentation of objective PD or to death on study due to any cause, whichever came first. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose. Results presented here were based on independent central review.
Analysis population: PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
Groups in this outcome
ALK Positive Population (Phase 1)
This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
ROS1 Positive Population (Phase 1)
This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
| Group | Source count |
|---|---|
| ALK Positive Population (Phase 1) | 41 |
| ROS1 Positive Population (Phase 1) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALK Positive Population (Phase 1) | 5.4 | Not reported | 2.7 | 11.8 | Not reported |
| ROS1 Positive Population (Phase 1) | 10.1 | Not reported | 1.6 | 33.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- 11.8
- value
- 5.4
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 33.0
- value
- 10.1
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- PFS was defined as the time from the first dose of study treatment to the first documentation of objective PD or to death on study due to any cause, whichever came first. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose. Results presented here were based on independent central review.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
- id
- OG000
- title
- ALK Positive Population (Phase 1)
- description
- This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
- id
- OG001
- title
- ROS1 Positive Population (Phase 1)
- param Type
- MEDIAN
- population Description
- PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
- reporting Status
- POSTED
- time Frame
- From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately)
- title
- Progression-Free Survival (PFS) (Phase 1)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice