Baseline characteristics

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) · Source last updated 2023-02-06

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

      13

   2. group Id

      BG001

      value

      17

   3. group Id

      BG002

      value

      0

   4. group Id

      BG003

      value

      0

   5. group Id

      BG004

      value

      30

   units

   Participants

groups

1. description

   Participants received GSK3326595 400 milligram (mg), tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

   id

   BG000

   title

   Part 1: GSK3326595 400 mg

2. description

   Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

   id

   BG001

   title

   Part 1: GSK3326595 300 mg

3. description

   Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.

   id

   BG002

   title

   Part 2-Dose Escalation: GSK3326595+5-Azacitidine

4. description

   Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

   id

   BG003

   title

   Part 2-Dose Expansion: GSK3326595+5-Azacitidine

5. description

   Total of all reporting groups

   id

   BG004

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            9.25

            value

            70.2

         2. group Id

            BG001

            spread

            9.61

            value

            72.8

         3. group Id

            BG004

            spread

            9.38

            value

            71.7

   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

            3

         2. group Id

            BG001

            value

            4

         3. group Id

            BG004

            value

            7

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            10

         2. group Id

            BG001

            value

            13

         3. group Id

            BG004

            value

            23

         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

            3

         2. group Id

            BG001

            value

            0

         3. group Id

            BG004

            value

            3

         title

         Black or African American

      2. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG004

            value

            1

         title

         Asian - East Asian Heritage

      3. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG004

            value

            1

         title

         White - Arabic/North African Heritage

      4. measurements

         1. group Id

            BG000

            value

            8

         2. group Id

            BG001

            value

            14

         3. group Id

            BG004

            value

            22

         title

         White - White/Caucasian/European Heritage

      5. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG004

            value

            1

         title

         Mixed Race

      6. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            2

         3. group Id

            BG004

            value

            2

         title

         Unknown

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

population Description

All Treated Population consisted of all participants who received at least one dose of GSK3326595 as monotherapy or at least one dose of both combination drugs as combination treatment. Data was not collected in Part 2 of the study as no participant was enrolled in Part 2.

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Preserved source evidence · Not medical advice