Baseline characteristics

A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma · Source last updated 2009-12-24

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

      32

   2. group Id

      BG001

      value

      19

   3. group Id

      BG002

      value

      51

   units

   Participants

groups

1. description

   Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.

   id

   BG000

   title

   Plitidepsin

2. description

   Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.

   id

   BG001

   title

   Plitidepsin + Dexamethasone

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            47

            upper Limit

            82

            value

            66

         2. group Id

            BG001

            lower Limit

            47

            upper Limit

            86

            value

            63

         3. group Id

            BG002

            lower Limit

            47

            upper Limit

            86

            value

            64.0

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            15

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            21

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            17

         2. group Id

            BG001

            value

            13

         3. group Id

            BG002

            value

            30

         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

            6

         2. group Id

            BG001

            value

            6

         3. group Id

            BG002

            value

            12

      title

      0 Units of Scale

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            18

         2. group Id

            BG001

            value

            9

         3. group Id

            BG002

            value

            27

      title

      1 Units of Scale

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            8

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            12

      title

      2 Units of Scale

   description

   ECOG PS: Eastern Cooperative Oncology Group Performance Status This scale is used by doctors to assess how a patient's disease is progressing, how the disease affects the daily living abilities of patients, and determine appropriate treatment and prognosis. Scale points: 0, 1, 2, 3, 4 \& 5; 0: Fully active, able to carry on all pre-disease performance without restriction, and 5: Death

   param Type

   NUMBER

   title

   ECOG PS

   unit Of Measure

   patients

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Preserved source evidence · Not medical advice