Baseline characteristics

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects · Source last updated 2014-07-25

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

      17

   2. group Id

      BG001

      value

      5

   3. group Id

      BG002

      value

      22

   units

   Participants

groups

1. description

   Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg

   id

   BG000

   title

   Romiplostim

2. description

   Placebo by subcutaneous injection once weekly

   id

   BG001

   title

   Placebo

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            5.4

            value

            9.4

         2. group Id

            BG001

            spread

            4.6

            value

            9.8

         3. group Id

            BG002

            spread

            5.1

            value

            9.5

   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

            4

         2. group Id

            BG001

            value

            2

         3. group Id

            BG002

            value

            6

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            3

         3. group Id

            BG002

            value

            16

         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

            9

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            13

      title

      White or Caucasian

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            5

      title

      Black or African American

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            3

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            3

      title

      Hispanic or Latino

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      Other

   param Type

   NUMBER

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice