Baseline characteristics

A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia · Source last updated 2015-12-22

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

      7

   2. group Id

      BG001

      value

      15

   3. group Id

      BG002

      value

      22

   units

   Participants

groups

1. description

   Participants received body-weight and BSA stratified dose of midostaurin 30 mg/m\^2 bid through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2.

   id

   BG000

   title

   Cohort 1: Midostaurin (30 Milligrams/Meters^2)

2. description

   Participants received body-weight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2.

   id

   BG001

   title

   Cohort 2: Midostaurin (60 mg/m^2)

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            7.479

            value

            9.65

         2. group Id

            BG001

            spread

            6.903

            value

            6.50

         3. group Id

            BG002

            spread

            7.070

            value

            7.50

   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

            2

         2. group Id

            BG001

            value

            9

         3. group Id

            BG002

            value

            11

      title

      Infants and toddlers (28 days-23 months)

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            2

      title

      Children (2--11 years)

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            4

         2. group Id

            BG001

            value

            5

         3. group Id

            BG002

            value

            9

      title

      Adolescents (12--17 years)

   param Type

   NUMBER

   title

   Age, Customized

   unit Of Measure

   participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            10

         3. group Id

            BG002

            value

            15

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            2

         2. group Id

            BG001

            value

            5

         3. group Id

            BG002

            value

            7

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

population Description

The analysis was performed in full analysis set (FAS) population, defined as all participants to whom study treatment was assigned.

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Preserved source evidence · Not medical advice