TriangleNCT02573259 · OUTCOME
Time to Response (TTR) Based on RECIST Version 1.1 - Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Baseline up to end of treatment in Part 2 (maximum of 851 days)
What was measured
TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.
Analysis population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
Groups in this outcome
Part 2: PF-06801591 300 mg (SC) for NSCLC
Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
Part 2: PF-06801591 300 mg (SC) for UC
Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
| Group | Source count |
|---|---|
| Part 2: PF-06801591 300 mg (SC) for NSCLC | 14 |
| Part 2: PF-06801591 300 mg (SC) for UC | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: PF-06801591 300 mg (SC) for NSCLC | 2.71 | Not reported | 1.4 | 12.0 | Not reported |
| Part 2: PF-06801591 300 mg (SC) for UC | 2.33 | Not reported | 1.4 | 5.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 12.0
- value
- 2.71
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 5.5
- value
- 2.33
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.
- dispersion Type
- Full Range
- groups
- description
- Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
- id
- OG000
- title
- Part 2: PF-06801591 300 mg (SC) for NSCLC
- description
- Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
- id
- OG001
- title
- Part 2: PF-06801591 300 mg (SC) for UC
- param Type
- MEDIAN
- population Description
- Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment in Part 2 (maximum of 851 days)
- title
- Time to Response (TTR) Based on RECIST Version 1.1 - Part 2
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice