TriangleNCT01693562 · OUTCOME
Adjusted Comparison of PFS by PD-L1 Status in UC Cohort in the Dose-expansion Phase
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 Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
What was measured
The PFS by PD-L1 status in UC cohort is reported. The PFS estimates are adjusted for baseline eastern cooperative oncology (ECOG), smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.
Analysis population: The UC cohort participants with PD-L1 status as high (\>= 25% tumor cell membrane or \>=25% immune cell staining) and low/negative (\<25% tumor cell membrane and \<25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.
Groups in this outcome
Expansion UC PD-L1 High Cohort
Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion UC PD-L1 Low/Negative Cohort
Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
| Group | Source count |
|---|---|
| Expansion UC PD-L1 High Cohort | 61 |
| Expansion UC PD-L1 Low/Negative Cohort | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion UC PD-L1 High Cohort | 2.6 | Not reported | 1.4 | 3.9 | Not reported |
| Expansion UC PD-L1 Low/Negative Cohort | 1.5 | Not reported | 1.4 | 2.4 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Other
- non Inferiority Type
- EQUIVALENCE
- p Value
- 0.016
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Other
- non Inferiority Type
- EQUIVALENCE
- p Value
- 0.016
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 3.9
- value
- 2.6
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 2.4
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- The PFS by PD-L1 status in UC cohort is reported. The PFS estimates are adjusted for baseline eastern cooperative oncology (ECOG), smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG000
- title
- Expansion UC PD-L1 High Cohort
- description
- Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG001
- title
- Expansion UC PD-L1 Low/Negative Cohort
- param Type
- MEDIAN
- population Description
- The UC cohort participants with PD-L1 status as high (\>= 25% tumor cell membrane or \>=25% immune cell staining) and low/negative (\<25% tumor cell membrane and \<25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The "Number of participants Analyzed" denotes the number of participants evaluated for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
- title
- Adjusted Comparison of PFS by PD-L1 Status in UC Cohort in the Dose-expansion Phase
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice