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NCT01957644 · BASELINE

Baseline characteristics

Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML · Source last updated 2019-02-08

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      16
    units
    Participants
groups
  1. description
    Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
    id
    BG000
    title
    Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
  2. description
    Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    BG001
    title
    Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
  3. description
    Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
    id
    BG002
    title
    Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
  4. description
    Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    BG003
    title
    Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
  5. description
    Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    BG004
    title
    Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.2
          value
          69.5
        2. group Id
          BG001
          spread
          7.7
          value
          69.2
        3. comment
          One patient in this group
          group Id
          BG002
          spread
          NA
          value
          60.0
        4. group Id
          BG003
          spread
          13.4
          value
          64.5
        5. comment
          One patient in this group
          group Id
          BG004
          spread
          NA
          value
          81.0
        6. group Id
          BG005
          spread
          8.5
          value
          68.9
    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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          13
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Treated set (TS): All entered patients receiving ≥1 dose of study medication were included in the TS
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      16
    units
    Participants
groups
  1. description
    Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
    id
    BG000
    title
    Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
  2. description
    Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    BG001
    title
    Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
  3. description
    Patients were intravenously administered volasertib 250 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle) in the expansion cohort
    id
    BG002
    title
    Volasertib 250 mg + Azacitidine (Expansion Cohort)- Part 1
  4. description
    Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    BG003
    title
    Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
  5. description
    Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    BG004
    title
    Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.2
          value
          69.5
        2. group Id
          BG001
          spread
          7.7
          value
          69.2
        3. comment
          One patient in this group
          group Id
          BG002
          spread
          NA
          value
          60.0
        4. group Id
          BG003
          spread
          13.4
          value
          64.5
        5. comment
          One patient in this group
          group Id
          BG004
          spread
          NA
          value
          81.0
        6. group Id
          BG005
          spread
          8.5
          value
          68.9
    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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          13
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Treated set (TS): All entered patients receiving ≥1 dose of study medication were included in the TS

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Preserved source evidence · Not medical advice