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NCT04579679 · BASELINE

Baseline characteristics

Open-Label Surufatinib in European Patients With NET · Source last updated 2025-07-25

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
      20
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      78
    units
    Participants
groups
  1. description
    Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG000
    title
    Cohort A (NET, Lung)
  2. description
    Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG001
    title
    Cohort B (NET, Small Bowel)
  3. description
    Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG002
    title
    Cohort C (NET, Other)
  4. description
    Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG003
    title
    Cohort D (NET, Any)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.77
          value
          63.5
        2. group Id
          BG001
          spread
          10.44
          value
          62.1
        3. group Id
          BG002
          spread
          15.52
          value
          57.3
        4. group Id
          BG003
          spread
          7.40
          value
          63.5
        5. group Id
          BG004
          spread
          12.37
          value
          61.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          38
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          59
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        title
        Not Reported
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The safety analysis set included all patients who received at least 1 dose of surufatinib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      78
    units
    Participants
groups
  1. description
    Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG000
    title
    Cohort A (NET, Lung)
  2. description
    Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG001
    title
    Cohort B (NET, Small Bowel)
  3. description
    Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG002
    title
    Cohort C (NET, Other)
  4. description
    Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
    id
    BG003
    title
    Cohort D (NET, Any)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.77
          value
          63.5
        2. group Id
          BG001
          spread
          10.44
          value
          62.1
        3. group Id
          BG002
          spread
          15.52
          value
          57.3
        4. group Id
          BG003
          spread
          7.40
          value
          63.5
        5. group Id
          BG004
          spread
          12.37
          value
          61.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          38
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          59
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        title
        Not Reported
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The safety analysis set included all patients who received at least 1 dose of surufatinib.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice