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NCT02064387 · BASELINE

Baseline characteristics

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      8
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      6
    11. group Id
      BG010
      value
      35
    12. group Id
      BG011
      value
      6
    units
    Participants
groups
  1. description
    Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG000
    title
    Part 1: GSK2857916 0.03 mg/kg
  2. description
    Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG001
    title
    Part 1: GSK2857916 0.06 mg/kg
  3. description
    Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG002
    title
    Part 1: GSK2857916 0.12 mg/kg
  4. description
    Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG003
    title
    Part 1: GSK2857916 0.24 mg/kg
  5. description
    Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG004
    title
    Part 1: GSK2857916 0.48 mg/kg
  6. description
    Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG005
    title
    Part 1: GSK2857916 0.96 mg/kg
  7. description
    Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG006
    title
    Part 1: GSK2857916 1.92 mg/kg
  8. description
    Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG007
    title
    Part 1: GSK2857916 2.50 mg/kg
  9. description
    Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG008
    title
    Part 1: GSK2857916 3.40 mg/kg
  10. description
    Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG009
    title
    Part 1: GSK2857916 4.60 mg/kg
  11. description
    Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
    id
    BG010
    title
    Part 2: GSK2857916 3.40 mg/kg (MM)
  12. description
    Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
    id
    BG011
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          NA indicates that standard deviation could not be calculated for a single participant.
          group Id
          BG000
          spread
          NA
          value
          49.0
        2. comment
          NA indicates that standard deviation could not be calculated for a single participant.
          group Id
          BG001
          spread
          NA
          value
          71.0
        3. group Id
          BG002
          spread
          3.32
          value
          56.5
        4. group Id
          BG003
          spread
          8.35
          value
          58.5
        5. group Id
          BG004
          spread
          10.89
          value
          60.0
        6. group Id
          BG005
          spread
          13.05
          value
          58.7
        7. group Id
          BG006
          spread
          4.79
          value
          65.3
        8. group Id
          BG007
          spread
          11.04
          value
          62.6
        9. group Id
          BG008
          spread
          8.19
          value
          48.0
        10. group Id
          BG009
          spread
          10.11
          value
          54.8
        11. group Id
          BG010
          spread
          7.93
          value
          60.5
        12. group Id
          BG011
          spread
          9.81
          value
          60.2
    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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          18
        12. group Id
          BG011
          value
          3
        title
        Female
      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
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          17
        12. group Id
          BG011
          value
          3
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Arabic/North African Heritage
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          28
        12. group Id
          BG011
          value
          6
        title
        White/Caucasian/European Heritage
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Japanese Heritage
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        South East Asian Heritage
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      3
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      8
    9. group Id
      BG008
      value
      3
    10. group Id
      BG009
      value
      6
    11. group Id
      BG010
      value
      35
    12. group Id
      BG011
      value
      6
    units
    Participants
groups
  1. description
    Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG000
    title
    Part 1: GSK2857916 0.03 mg/kg
  2. description
    Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG001
    title
    Part 1: GSK2857916 0.06 mg/kg
  3. description
    Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG002
    title
    Part 1: GSK2857916 0.12 mg/kg
  4. description
    Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG003
    title
    Part 1: GSK2857916 0.24 mg/kg
  5. description
    Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG004
    title
    Part 1: GSK2857916 0.48 mg/kg
  6. description
    Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG005
    title
    Part 1: GSK2857916 0.96 mg/kg
  7. description
    Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG006
    title
    Part 1: GSK2857916 1.92 mg/kg
  8. description
    Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG007
    title
    Part 1: GSK2857916 2.50 mg/kg
  9. description
    Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG008
    title
    Part 1: GSK2857916 3.40 mg/kg
  10. description
    Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    BG009
    title
    Part 1: GSK2857916 4.60 mg/kg
  11. description
    Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
    id
    BG010
    title
    Part 2: GSK2857916 3.40 mg/kg (MM)
  12. description
    Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
    id
    BG011
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          NA indicates that standard deviation could not be calculated for a single participant.
          group Id
          BG000
          spread
          NA
          value
          49.0
        2. comment
          NA indicates that standard deviation could not be calculated for a single participant.
          group Id
          BG001
          spread
          NA
          value
          71.0
        3. group Id
          BG002
          spread
          3.32
          value
          56.5
        4. group Id
          BG003
          spread
          8.35
          value
          58.5
        5. group Id
          BG004
          spread
          10.89
          value
          60.0
        6. group Id
          BG005
          spread
          13.05
          value
          58.7
        7. group Id
          BG006
          spread
          4.79
          value
          65.3
        8. group Id
          BG007
          spread
          11.04
          value
          62.6
        9. group Id
          BG008
          spread
          8.19
          value
          48.0
        10. group Id
          BG009
          spread
          10.11
          value
          54.8
        11. group Id
          BG010
          spread
          7.93
          value
          60.5
        12. group Id
          BG011
          spread
          9.81
          value
          60.2
    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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          18
        12. group Id
          BG011
          value
          3
        title
        Female
      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
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          17
        12. group Id
          BG011
          value
          3
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Arabic/North African Heritage
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          28
        12. group Id
          BG011
          value
          6
        title
        White/Caucasian/European Heritage
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Japanese Heritage
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        South East Asian Heritage
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice