Baseline characteristics

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) · Source last updated 2013-12-18

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

      292

   2. group Id

      BG001

      value

      21

   3. group Id

      BG002

      value

      313

   units

   Participants

groups

1. description

   Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.

   id

   BG000

   title

   Romiplostim in Adults

2. description

   Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.

   id

   BG001

   title

   Romiplostim in Pediatric Population

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            16.9

            value

            54.2

         2. group Id

            BG001

            spread

            5.1

            value

            10.2

         3. group Id

            BG002

            spread

            19.7

            value

            51.3

   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

            184

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            190

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            108

         2. group Id

            BG001

            value

            15

         3. group Id

            BG002

            value

            123

         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

            13

         2. group Id

            BG001

            value

            3

         3. group Id

            BG002

            value

            16

      title

      Black or African American

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            246

         2. group Id

            BG001

            value

            13

         3. group Id

            BG002

            value

            259

      title

      White or Caucasian

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            21

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            25

      title

      Hispanic or Latino

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            9

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            9

      title

      Asian

   5. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

      title

      Japanese

   6. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

      title

      American Indian or Alaska Native

   7. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

      title

      Native Hawaiian or Other Pacific Islander

   8. 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