TriangleNCT02612194 · OUTCOME
Progression Free Survival
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 date of treatment start to date of progression or death, or censored as described above; assessed for approximately 2 years.
What was measured
PFS was defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled assessments will be censored at date of last assessment prior to first missed assessment.
Analysis population: Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.
Groups in this outcome
Total Enrolled Study Cohort
This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
| Group | Source count |
|---|---|
| Total Enrolled Study Cohort | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Enrolled Study Cohort | 1.5 | Not reported | 0.2 | 1.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.8
- estimate Comment
- The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.
- group Ids
- OG000
- non Inferiority Comment
- Estimation only
- non Inferiority Type
- OTHER
- param Type
- Median
- param Value
- 1.5
Complete source fields
- analyses
- ci Lower Limit
- 0.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.8
- estimate Comment
- The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.
- group Ids
- OG000
- non Inferiority Comment
- Estimation only
- non Inferiority Type
- OTHER
- param Type
- Median
- param Value
- 1.5
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 1.8
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- PFS was defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled assessments will be censored at date of last assessment prior to first missed assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
- id
- OG000
- title
- Total Enrolled Study Cohort
- param Type
- MEDIAN
- population Description
- Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.
- reporting Status
- POSTED
- time Frame
- From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 2 years.
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice