TriangleNCT02573259 · OUTCOME
Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to end of treatment in Part 1 (maximum of 1606 days)
What was measured
Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 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 be 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 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
Part 1: PF-06801591 1 mg/kg (IV)
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
Part 1: PF-06801591 3 mg/kg (IV)
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
Part 1: PF-06801591 10 mg/kg (IV)
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
| Group | Source count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
| Part 1: PF-06801591 1 mg/kg (IV) | 7 |
| Part 1: PF-06801591 3 mg/kg (IV) | 8 |
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 1 mg/kg (IV) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 3 mg/kg (IV) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 10 mg/kg (IV) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 15
- units
- Participants
- description
- Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 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 be assessed.
- groups
- description
- Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
- id
- OG000
- title
- Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
- description
- Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
- id
- OG001
- title
- Part 1: PF-06801591 1 mg/kg (IV)
- description
- Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
- id
- OG002
- title
- Part 1: PF-06801591 3 mg/kg (IV)
- description
- Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
- id
- OG003
- title
- Part 1: PF-06801591 10 mg/kg (IV)
- description
- Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
- id
- OG004
- title
- Part 1: PF-06801591 300 mg (Subcutaneously [SC])
- param Type
- COUNT_OF_PARTICIPANTS
- 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 1 (maximum of 1606 days)
- title
- Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice