NCT03914612 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 113
- group Id
- BG001
- value
- 112
- group Id
- BG002
- value
- 295
- group Id
- BG003
- value
- 293
- group Id
- BG004
- value
- 813
- units
- Participants
- groups
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG000
- title
- (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG001
- title
- (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG002
- title
- (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG003
- title
- (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 37
- upper Limit
- 85
- value
- 66
- group Id
- BG001
- lower Limit
- 38
- upper Limit
- 81
- value
- 67
- group Id
- BG002
- lower Limit
- 29
- upper Limit
- 90
- value
- 65
- group Id
- BG003
- lower Limit
- 31
- upper Limit
- 93
- value
- 66
- group Id
- BG004
- lower Limit
- 29
- upper Limit
- 93
- value
- 66
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 113
- group Id
- BG001
- value
- 112
- group Id
- BG002
- value
- 295
- group Id
- BG003
- value
- 293
- group Id
- BG004
- value
- 813
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 16
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 48
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 99
- group Id
- BG001
- value
- 106
- group Id
- BG002
- value
- 273
- group Id
- BG003
- value
- 263
- group Id
- BG004
- value
- 741
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 24
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 6
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 14
- group Id
- BG003
- value
- 17
- group Id
- BG004
- value
- 38
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 4
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 51
- group Id
- BG003
- value
- 45
- group Id
- BG004
- value
- 116
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 92
- group Id
- BG002
- value
- 212
- group Id
- BG003
- value
- 212
- group Id
- BG004
- value
- 602
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 15
- group Id
- BG004
- value
- 45
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Randomized population (with definitive MMR status)
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 113
- group Id
- BG001
- value
- 112
- group Id
- BG002
- value
- 295
- group Id
- BG003
- value
- 293
- group Id
- BG004
- value
- 813
- units
- Participants
- groups
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG000
- title
- (dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG001
- title
- (dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG002
- title
- (pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)
- description
- COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.
- id
- BG003
- title
- (pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 37
- upper Limit
- 85
- value
- 66
- group Id
- BG001
- lower Limit
- 38
- upper Limit
- 81
- value
- 67
- group Id
- BG002
- lower Limit
- 29
- upper Limit
- 90
- value
- 65
- group Id
- BG003
- lower Limit
- 31
- upper Limit
- 93
- value
- 66
- group Id
- BG004
- lower Limit
- 29
- upper Limit
- 93
- value
- 66
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 113
- group Id
- BG001
- value
- 112
- group Id
- BG002
- value
- 295
- group Id
- BG003
- value
- 293
- group Id
- BG004
- value
- 813
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 16
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 48
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 99
- group Id
- BG001
- value
- 106
- group Id
- BG002
- value
- 273
- group Id
- BG003
- value
- 263
- group Id
- BG004
- value
- 741
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 24
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 6
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 14
- group Id
- BG003
- value
- 17
- group Id
- BG004
- value
- 38
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 4
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 51
- group Id
- BG003
- value
- 45
- group Id
- BG004
- value
- 116
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 86
- group Id
- BG001
- value
- 92
- group Id
- BG002
- value
- 212
- group Id
- BG003
- value
- 212
- group Id
- BG004
- value
- 602
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 15
- group Id
- BG004
- value
- 45
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Randomized population (with definitive MMR status)
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Preserved source evidence · Not medical advice
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