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NCT05397171 · BASELINE

Baseline characteristics

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours · Source last updated 2024-10-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      16
    units
    Participants
groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    BG000
    title
    AZD8853 300 mg
  2. description
    Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    BG001
    title
    AZD8853 1000 mg
  3. description
    Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    BG002
    title
    AZD8853 3000 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.2
          value
          62.0
        2. group Id
          BG001
          spread
          4.2
          value
          62.8
        3. group Id
          BG002
          spread
          7.4
          value
          65.1
        4. group Id
          BG003
          spread
          7.3
          value
          63.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. comment
          Data are not reported due to concerns with participant's confidentiality.
          group Id
          BG000
          value
          NA
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Female
      2. measurements
        1. comment
          Data are not reported due to concerns with participant's confidentiality.
          group Id
          BG000
          value
          NA
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          13
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Not reported
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety set included all participants who received any amount of investigational product (IP).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      16
    units
    Participants
groups
  1. description
    Participants with advanced/metastatic solid tumors received AZD8853 300 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    BG000
    title
    AZD8853 300 mg
  2. description
    Participants with advanced/metastatic solid tumors received AZD8853 1000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    BG001
    title
    AZD8853 1000 mg
  3. description
    Participants with advanced/metastatic solid tumors received AZD8853 3000 mg every 3 weeks until progressive disease, unacceptable toxicity, or withdrawal of consent.
    id
    BG002
    title
    AZD8853 3000 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.2
          value
          62.0
        2. group Id
          BG001
          spread
          4.2
          value
          62.8
        3. group Id
          BG002
          spread
          7.4
          value
          65.1
        4. group Id
          BG003
          spread
          7.3
          value
          63.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. comment
          Data are not reported due to concerns with participant's confidentiality.
          group Id
          BG000
          value
          NA
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Female
      2. measurements
        1. comment
          Data are not reported due to concerns with participant's confidentiality.
          group Id
          BG000
          value
          NA
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG003
          value
          NA
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          13
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Not reported
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety set included all participants who received any amount of investigational product (IP).

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Preserved source evidence · Not medical advice