TriangleNCT01688999 · 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
- Median follow-up was 61.2 months
What was measured
Measure the timing of maintaining stable disease or partial response until disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest um diameters while on study.
Analysis population: 42/50 were analyzed in cohort 1 because 5 participants withdrew, 2 were taken off study for adverse events and 1 was ineligible. In cohort 2, 5/6 patients were analyzed because 1 withdrew; and in cohort 3, 10/13 patients were analyzed because 1 withdrew and 2 were taken off study due to adverse events.
Groups in this outcome
Cohort 1 - (Urothelial Progressive Disease)
Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
Cohort 2 (Bone-only)
Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
Cohort 3 (Rare Histologies)
Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
| Group | Source count |
|---|---|
| Cohort 1 - (Urothelial Progressive Disease) | 42 |
| Cohort 2 (Bone-only) | 5 |
| Cohort 3 (Rare Histologies) | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - (Urothelial Progressive Disease) | 3.7 | Not reported | 3.1 | 6.4 | Not reported |
| Cohort 2 (Bone-only) | 5.3 | Not reported | 1.8 | 8.3 | Not reported |
| Cohort 3 (Rare Histologies) | 2.9 | Not reported | 1.8 | 3.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.1
- upper Limit
- 6.4
- value
- 3.7
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 8.3
- value
- 5.3
- group Id
- OG002
- lower Limit
- 1.8
- upper Limit
- 3.7
- value
- 2.9
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Measure the timing of maintaining stable disease or partial response until disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest um diameters while on study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- id
- OG000
- title
- Cohort 1 - (Urothelial Progressive Disease)
- description
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- id
- OG001
- title
- Cohort 2 (Bone-only)
- description
- Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
- id
- OG002
- title
- Cohort 3 (Rare Histologies)
- param Type
- MEDIAN
- population Description
- 42/50 were analyzed in cohort 1 because 5 participants withdrew, 2 were taken off study for adverse events and 1 was ineligible. In cohort 2, 5/6 patients were analyzed because 1 withdrew; and in cohort 3, 10/13 patients were analyzed because 1 withdrew and 2 were taken off study due to adverse events.
- reporting Status
- POSTED
- time Frame
- Median follow-up was 61.2 months
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice