NCT05010629 · 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
- 16
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 32
- units
- Participants
- groups
- description
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- BG000
- title
- 9-ING-41 + Carboplatin (Part I)
- description
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- BG001
- title
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 13.6
- value
- 63.5
- group Id
- BG001
- spread
- 9.0
- value
- 63.6
- group Id
- BG002
- spread
- 11.3
- value
- 63.5
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 20
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 12
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- American Indian
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Asian
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- title
- Black/African American
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 27
- title
- White
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Other
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- population Description
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 16
- group Id
- BG002
- value
- 32
- units
- Participants
- groups
- description
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- BG000
- title
- 9-ING-41 + Carboplatin (Part I)
- description
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- BG001
- title
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 13.6
- value
- 63.5
- group Id
- BG001
- spread
- 9.0
- value
- 63.6
- group Id
- BG002
- spread
- 11.3
- value
- 63.5
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 20
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 12
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- American Indian
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Asian
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- title
- Black/African American
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 27
- title
- White
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- title
- Other
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- population Description
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
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Preserved source evidence · Independent clinical review pending · Not medical advice
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