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NCT03345485 · BASELINE

Baseline characteristics

Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21

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
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      2
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      4
    10. group Id
      BG009
      value
      12
    11. group Id
      BG010
      value
      6
    12. group Id
      BG011
      value
      6
    units
    Participants
groups
  1. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 60mg/m2 over a 30 minutes infusion time)
    id
    BG000
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min). Cohort 1
  2. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 30 minutes infusion time)
    id
    BG001
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min). Cohort 2
  3. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 100mg/m2 over a 30 minutes infusion time)
    id
    BG002
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min). Cohort 3
  4. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 60mg/m2 over a 60 minutes infusion time)
    id
    BG003
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min). Cohort 4
  5. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time)
    id
    BG004
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min). Cohort 5
  6. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 100mg/m2 over a 60 minutes infusion time)
    id
    BG005
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min). Cohort 6
  7. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory small cell lung cancer.
    id
    BG006
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC
  8. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory soft tissue sarcoma.
    id
    BG007
    title
    Tinostamustine (EDO-S101) - Phase 2 STS
  9. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory triple-negative breast cancer.
    id
    BG008
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC
  10. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory ovarian cancer.
    id
    BG009
    title
    Tinostamustine (EDO-S101) - Phase 2 OC
  11. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory endometrial cancer.
    id
    BG010
    title
    Tinostamustine (EDO-S101) - Phase 2 EC
  12. description
    Subgroup treated with a dose of study treatment at 60 mg/m2 over 60 minutes infusion time.
    id
    BG011
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      < 65
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      ≥ 65 or < 75
    3. 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
          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
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      ≥ 75
    description
    Age categories are defined per statistical analysis plan (SAP) document: 1. \< 65 years 2. ≥ 65 or \< 75 years 3. ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.12
          value
          61.0
        2. group Id
          BG001
          spread
          16.20
          value
          60.7
        3. group Id
          BG002
          spread
          8.74
          value
          61.3
        4. group Id
          BG003
          spread
          7.55
          value
          54.0
        5. group Id
          BG004
          spread
          13.55
          value
          61.3
        6. group Id
          BG005
          spread
          9.19
          value
          56.5
        7. group Id
          BG006
          spread
          6.56
          value
          62.5
        8. group Id
          BG007
          spread
          12.51
          value
          53.2
        9. group Id
          BG008
          spread
          18.39
          value
          62.8
        10. group Id
          BG009
          spread
          9.00
          value
          61.6
        11. group Id
          BG010
          spread
          8.74
          value
          62.0
        12. group Id
          BG011
          spread
          9.67
          value
          49.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          4
        title
        Not Hispanic or Latino
      3. 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
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          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
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        Asian
      3. 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
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      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
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        title
        White
      6. 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
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. 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
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      United States
    3. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      Italy
    4. 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
          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
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.87
          value
          166.6
        2. group Id
          BG001
          spread
          8.59
          value
          173.6
        3. group Id
          BG002
          spread
          24.75
          value
          165.5
        4. group Id
          BG003
          spread
          13.60
          value
          162.3
        5. group Id
          BG004
          spread
          16.13
          value
          169.7
        6. group Id
          BG005
          spread
          6.01
          value
          164.8
        7. group Id
          BG006
          spread
          12.98
          value
          166.6
        8. group Id
          BG007
          spread
          7.16
          value
          166.3
        9. group Id
          BG008
          spread
          6.78
          value
          159.1
        10. group Id
          BG009
          spread
          6.42
          value
          160.3
        11. group Id
          BG010
          spread
          3.57
          value
          160.4
        12. group Id
          BG011
          spread
          11.38
          value
          165.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    description
    Height at Screening
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    During screening visit height was recorded for 69 patients
    title
    Height
    unit Of Measure
    Centimeters
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          27.82
          value
          74.2
        2. group Id
          BG001
          spread
          7.51
          value
          92.5
        3. group Id
          BG002
          spread
          11.74
          value
          75.3
        4. group Id
          BG003
          spread
          8.87
          value
          93.7
        5. group Id
          BG004
          spread
          22.68
          value
          71.2
        6. group Id
          BG005
          spread
          25.31
          value
          87.6
        7. group Id
          BG006
          spread
          38.14
          value
          72.7
        8. group Id
          BG007
          spread
          29.17
          value
          78.6
        9. group Id
          BG008
          spread
          16.30
          value
          62.4
        10. group Id
          BG009
          spread
          15.23
          value
          68.4
        11. group Id
          BG010
          spread
          13.94
          value
          66.1
        12. group Id
          BG011
          spread
          27.79
          value
          97.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    description
    Weight at Screening
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    During screening visit weight was recorded for 70 patients
    title
    Weight
    unit Of Measure
    Kilograms
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.7819
          value
          31.620
        2. group Id
          BG001
          spread
          3.9493
          value
          30.850
        3. group Id
          BG002
          spread
          3.9810
          value
          27.775
        4. group Id
          BG003
          spread
          6.1309
          value
          35.970
        5. group Id
          BG004
          spread
          6.5699
          value
          24.539
        6. group Id
          BG005
          spread
          11.7026
          value
          32.675
        7. group Id
          BG006
          spread
          8.6313
          value
          25.148
        8. group Id
          BG007
          spread
          9.9631
          value
          28.206
        9. group Id
          BG008
          spread
          4.9410
          value
          24.483
        10. group Id
          BG009
          spread
          5.7605
          value
          26.616
        11. group Id
          BG010
          spread
          5.2798
          value
          25.677
        12. group Id
          BG011
          spread
          11.1967
          value
          36.168
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    description
    BMI (Body Mass Index) at screening
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    During screening visit BMI was recorded for 69 patients
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
population Description
Demographics and baseline characteristics are summarised for Safety Population. Demographic information included age, sex, ethnicity, race, height, weight and BMI. Demographics and baseline characteristics were summarised descriptively. Subject demographics (sex, ethnicity, race, and age category) were presented using discrete summary statistics. Age, height, weight and BMI were presented using continuous summary statistics.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      2
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      10
    9. group Id
      BG008
      value
      4
    10. group Id
      BG009
      value
      12
    11. group Id
      BG010
      value
      6
    12. group Id
      BG011
      value
      6
    units
    Participants
groups
  1. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 60mg/m2 over a 30 minutes infusion time)
    id
    BG000
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min). Cohort 1
  2. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 30 minutes infusion time)
    id
    BG001
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min). Cohort 2
  3. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 100mg/m2 over a 30 minutes infusion time)
    id
    BG002
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min). Cohort 3
  4. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 60mg/m2 over a 60 minutes infusion time)
    id
    BG003
    title
    Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min). Cohort 4
  5. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time)
    id
    BG004
    title
    Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min). Cohort 5
  6. description
    Safety Population (All patients who received at least one (1) dose of study treatment at 100mg/m2 over a 60 minutes infusion time)
    id
    BG005
    title
    Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min). Cohort 6
  7. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory small cell lung cancer.
    id
    BG006
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC
  8. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory soft tissue sarcoma.
    id
    BG007
    title
    Tinostamustine (EDO-S101) - Phase 2 STS
  9. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory triple-negative breast cancer.
    id
    BG008
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC
  10. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory ovarian cancer.
    id
    BG009
    title
    Tinostamustine (EDO-S101) - Phase 2 OC
  11. description
    Safety population (All patients who received at least one (1) dose of study treatment at 80mg/m2 over a 60 minutes infusion time) in patients with relapsed/refractory endometrial cancer.
    id
    BG010
    title
    Tinostamustine (EDO-S101) - Phase 2 EC
  12. description
    Subgroup treated with a dose of study treatment at 60 mg/m2 over 60 minutes infusion time.
    id
    BG011
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      < 65
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      ≥ 65 or < 75
    3. 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
          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
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      ≥ 75
    description
    Age categories are defined per statistical analysis plan (SAP) document: 1. \< 65 years 2. ≥ 65 or \< 75 years 3. ≥ 75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.12
          value
          61.0
        2. group Id
          BG001
          spread
          16.20
          value
          60.7
        3. group Id
          BG002
          spread
          8.74
          value
          61.3
        4. group Id
          BG003
          spread
          7.55
          value
          54.0
        5. group Id
          BG004
          spread
          13.55
          value
          61.3
        6. group Id
          BG005
          spread
          9.19
          value
          56.5
        7. group Id
          BG006
          spread
          6.56
          value
          62.5
        8. group Id
          BG007
          spread
          12.51
          value
          53.2
        9. group Id
          BG008
          spread
          18.39
          value
          62.8
        10. group Id
          BG009
          spread
          9.00
          value
          61.6
        11. group Id
          BG010
          spread
          8.74
          value
          62.0
        12. group Id
          BG011
          spread
          9.67
          value
          49.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          4
        title
        Not Hispanic or Latino
      3. 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
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          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
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        Asian
      3. 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
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      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
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          5
        title
        White
      6. 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
          0
        12. group Id
          BG011
          value
          0
        title
        More than one race
      7. 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
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      United States
    3. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      Italy
    4. 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
          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
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.87
          value
          166.6
        2. group Id
          BG001
          spread
          8.59
          value
          173.6
        3. group Id
          BG002
          spread
          24.75
          value
          165.5
        4. group Id
          BG003
          spread
          13.60
          value
          162.3
        5. group Id
          BG004
          spread
          16.13
          value
          169.7
        6. group Id
          BG005
          spread
          6.01
          value
          164.8
        7. group Id
          BG006
          spread
          12.98
          value
          166.6
        8. group Id
          BG007
          spread
          7.16
          value
          166.3
        9. group Id
          BG008
          spread
          6.78
          value
          159.1
        10. group Id
          BG009
          spread
          6.42
          value
          160.3
        11. group Id
          BG010
          spread
          3.57
          value
          160.4
        12. group Id
          BG011
          spread
          11.38
          value
          165.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    description
    Height at Screening
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    During screening visit height was recorded for 69 patients
    title
    Height
    unit Of Measure
    Centimeters
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          27.82
          value
          74.2
        2. group Id
          BG001
          spread
          7.51
          value
          92.5
        3. group Id
          BG002
          spread
          11.74
          value
          75.3
        4. group Id
          BG003
          spread
          8.87
          value
          93.7
        5. group Id
          BG004
          spread
          22.68
          value
          71.2
        6. group Id
          BG005
          spread
          25.31
          value
          87.6
        7. group Id
          BG006
          spread
          38.14
          value
          72.7
        8. group Id
          BG007
          spread
          29.17
          value
          78.6
        9. group Id
          BG008
          spread
          16.30
          value
          62.4
        10. group Id
          BG009
          spread
          15.23
          value
          68.4
        11. group Id
          BG010
          spread
          13.94
          value
          66.1
        12. group Id
          BG011
          spread
          27.79
          value
          97.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    description
    Weight at Screening
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    During screening visit weight was recorded for 70 patients
    title
    Weight
    unit Of Measure
    Kilograms
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.7819
          value
          31.620
        2. group Id
          BG001
          spread
          3.9493
          value
          30.850
        3. group Id
          BG002
          spread
          3.9810
          value
          27.775
        4. group Id
          BG003
          spread
          6.1309
          value
          35.970
        5. group Id
          BG004
          spread
          6.5699
          value
          24.539
        6. group Id
          BG005
          spread
          11.7026
          value
          32.675
        7. group Id
          BG006
          spread
          8.6313
          value
          25.148
        8. group Id
          BG007
          spread
          9.9631
          value
          28.206
        9. group Id
          BG008
          spread
          4.9410
          value
          24.483
        10. group Id
          BG009
          spread
          5.7605
          value
          26.616
        11. group Id
          BG010
          spread
          5.2798
          value
          25.677
        12. group Id
          BG011
          spread
          11.1967
          value
          36.168
      denoms
      1. counts
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          12
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          6
        units
        Participants
    description
    BMI (Body Mass Index) at screening
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    During screening visit BMI was recorded for 69 patients
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
population Description
Demographics and baseline characteristics are summarised for Safety Population. Demographic information included age, sex, ethnicity, race, height, weight and BMI. Demographics and baseline characteristics were summarised descriptively. Subject demographics (sex, ethnicity, race, and age category) were presented using discrete summary statistics. Age, height, weight and BMI were presented using continuous summary statistics.

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Preserved source evidence · Not medical advice