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NCT03724253 · BASELINE

Baseline characteristics

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) · Source last updated 2020-10-23

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
      5
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      19
    units
    Participants
groups
  1. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG000
    title
    Breast
  2. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG001
    title
    Prostate
  3. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG002
    title
    Colorectal
  4. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG003
    title
    Non-Small Cell Lung Cancer (NSCLC)
  5. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG004
    title
    Small-Cell Lung Cancer (SCLC)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.60
          value
          61.8
        2. group Id
          BG001
          spread
          6.31
          value
          65.4
        3. group Id
          BG002
          spread
          13.68
          value
          64.2
        4. group Id
          BG003
          spread
          3.21
          value
          64.7
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          54.0
        6. group Id
          BG005
          spread
          8.46
          value
          63.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
      title
      Not Collected
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.53
          value
          70.6
        2. group Id
          BG001
          spread
          7.46
          value
          85.2
        3. group Id
          BG002
          spread
          8.63
          value
          72.6
        4. group Id
          BG003
          spread
          23.38
          value
          72.1
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          62.8
        6. group Id
          BG005
          spread
          12.64
          value
          74.8
    description
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Weight
    unit Of Measure
    kilogram (kg)
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.21
          value
          165.6
        2. group Id
          BG001
          spread
          5.94
          value
          175.4
        3. group Id
          BG002
          spread
          6.23
          value
          170.4
        4. group Id
          BG003
          spread
          3.51
          value
          165.7
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          168.0
        6. group Id
          BG005
          spread
          10.7
          value
          169.6
    description
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Height
    unit Of Measure
    centimeter (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.563
          value
          25.84
        2. group Id
          BG001
          spread
          3.202
          value
          27.79
        3. group Id
          BG002
          spread
          1.514
          value
          24.90
        4. group Id
          BG003
          spread
          7.552
          value
          26.04
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          22.25
        6. group Id
          BG005
          spread
          3.970
          value
          25.95
    description
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Body Mass Index
    unit Of Measure
    kilogram per square metre (kg/m^2)
  7. 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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        IIIA
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        IIIC
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          16
        title
        IV
    description
    The overall diagnostic stage uses the stage at screening visit and the Tumour, Node, Metastasis (TNM) staging uses the latest available stage. Stage III indicates a locally advanced cancer that is likely to grow and spread; stage IIIA = the cancer has spread into nearby tissues; stage IIIC = the cancer cells across the tumor are poorly differentiated, meaning they look very different from healthy cells. Stage IV means that the cancer has spread to distant parts of the body and may be called advanced or metastatic cancer.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnostic Stage
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          64.61
          value
          117.3
        2. group Id
          BG001
          spread
          74.48
          value
          50.5
        3. group Id
          BG002
          spread
          25.40
          value
          24.3
        4. group Id
          BG003
          spread
          1.46
          value
          1.6
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          1.1
        6. group Id
          BG005
          spread
          65.32
          value
          50.9
    description
    Time from initial diagnosis (months) is calculated as (date of IMP administration - date of initial diagnosis + 1)/30.4375.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from Initial Diagnosis of Primary Disease
    unit Of Measure
    Months
population Description
Full Analysis Set (FAS) = all subjects who enter the study and receive the \[68Ga\]-NeoBOMB1 dose.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      5
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      19
    units
    Participants
groups
  1. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG000
    title
    Breast
  2. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG001
    title
    Prostate
  3. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG002
    title
    Colorectal
  4. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG003
    title
    Non-Small Cell Lung Cancer (NSCLC)
  5. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    BG004
    title
    Small-Cell Lung Cancer (SCLC)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.60
          value
          61.8
        2. group Id
          BG001
          spread
          6.31
          value
          65.4
        3. group Id
          BG002
          spread
          13.68
          value
          64.2
        4. group Id
          BG003
          spread
          3.21
          value
          64.7
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          54.0
        6. group Id
          BG005
          spread
          8.46
          value
          63.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          11
      title
      Not Collected
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.53
          value
          70.6
        2. group Id
          BG001
          spread
          7.46
          value
          85.2
        3. group Id
          BG002
          spread
          8.63
          value
          72.6
        4. group Id
          BG003
          spread
          23.38
          value
          72.1
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          62.8
        6. group Id
          BG005
          spread
          12.64
          value
          74.8
    description
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Weight
    unit Of Measure
    kilogram (kg)
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.21
          value
          165.6
        2. group Id
          BG001
          spread
          5.94
          value
          175.4
        3. group Id
          BG002
          spread
          6.23
          value
          170.4
        4. group Id
          BG003
          spread
          3.51
          value
          165.7
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          168.0
        6. group Id
          BG005
          spread
          10.7
          value
          169.6
    description
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Height
    unit Of Measure
    centimeter (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.563
          value
          25.84
        2. group Id
          BG001
          spread
          3.202
          value
          27.79
        3. group Id
          BG002
          spread
          1.514
          value
          24.90
        4. group Id
          BG003
          spread
          7.552
          value
          26.04
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          22.25
        6. group Id
          BG005
          spread
          3.970
          value
          25.95
    description
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Body Mass Index
    unit Of Measure
    kilogram per square metre (kg/m^2)
  7. 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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        IIIA
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        IIIC
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          16
        title
        IV
    description
    The overall diagnostic stage uses the stage at screening visit and the Tumour, Node, Metastasis (TNM) staging uses the latest available stage. Stage III indicates a locally advanced cancer that is likely to grow and spread; stage IIIA = the cancer has spread into nearby tissues; stage IIIC = the cancer cells across the tumor are poorly differentiated, meaning they look very different from healthy cells. Stage IV means that the cancer has spread to distant parts of the body and may be called advanced or metastatic cancer.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnostic Stage
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          64.61
          value
          117.3
        2. group Id
          BG001
          spread
          74.48
          value
          50.5
        3. group Id
          BG002
          spread
          25.40
          value
          24.3
        4. group Id
          BG003
          spread
          1.46
          value
          1.6
        5. comment
          Only one participant analyzed
          group Id
          BG004
          spread
          NA
          value
          1.1
        6. group Id
          BG005
          spread
          65.32
          value
          50.9
    description
    Time from initial diagnosis (months) is calculated as (date of IMP administration - date of initial diagnosis + 1)/30.4375.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time from Initial Diagnosis of Primary Disease
    unit Of Measure
    Months
population Description
Full Analysis Set (FAS) = all subjects who enter the study and receive the \[68Ga\]-NeoBOMB1 dose.

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Preserved source evidence · Not medical advice