Baseline characteristics

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia · Source last updated 2023-04-18

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

      224

   2. group Id

      BG001

      value

      112

   3. group Id

      BG002

      value

      336

   units

   Participants

groups

1. description

   Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care

   id

   BG000

   title

   Luspatercept + BSC

2. description

   Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care

   id

   BG001

   title

   Placebo + BSC

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            10.67

            value

            32.2

         2. group Id

            BG001

            spread

            9.89

            value

            31.9

         3. group Id

            BG002

            spread

            10.40

            value

            32.1

   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

            132

         2. group Id

            BG001

            value

            63

         3. group Id

            BG002

            value

            195

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            92

         2. group Id

            BG001

            value

            49

         3. group Id

            BG002

            value

            141

         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

            5

         2. group Id

            BG001

            value

            2

         3. group Id

            BG002

            value

            7

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            218

         2. group Id

            BG001

            value

            107

         3. group Id

            BG002

            value

            325

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            3

         3. group Id

            BG002

            value

            4

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            81

         2. group Id

            BG001

            value

            36

         3. group Id

            BG002

            value

            117

         title

         Asian

      2. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

         title

         Black or African American

      3. measurements

         1. group Id

            BG000

            value

            122

         2. group Id

            BG001

            value

            60

         3. group Id

            BG002

            value

            182

         title

         White

      4. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            5

         3. group Id

            BG002

            value

            10

         title

         Not collected or reported

      5. measurements

         1. group Id

            BG000

            value

            15

         2. group Id

            BG001

            value

            11

         3. group Id

            BG002

            value

            26

         title

         Other

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

population Description

All randomized participants

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Preserved source evidence · Not medical advice