Baseline characteristics

Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia · Source last updated 2020-08-10

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

      153

   2. group Id

      BG001

      value

      156

   3. group Id

      BG002

      value

      309

   units

   Participants

groups

1. description

   Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.

   id

   BG000

   title

   Arm A (CPX-351)

2. description

   Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.

   id

   BG001

   title

   Arm B (7+3)

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            4.19

            value

            67.8

         2. group Id

            BG001

            spread

            4.1

            value

            67.7

         3. group Id

            BG002

            spread

            4.14

            value

            67.7

   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

            59

         2. group Id

            BG001

            value

            60

         3. group Id

            BG002

            value

            119

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            94

         2. group Id

            BG001

            value

            96

         3. group Id

            BG002

            value

            190

         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

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            6

         2. group Id

            BG001

            value

            2

         3. group Id

            BG002

            value

            8

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            7

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            13

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            128

         2. group Id

            BG001

            value

            139

         3. group Id

            BG002

            value

            267

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            11

         2. group Id

            BG001

            value

            8

         3. group Id

            BG002

            value

            19

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

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Preserved source evidence · Not medical advice