Baseline characteristics

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD) · Source last updated 2014-04-17

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

      36

   2. group Id

      BG001

      value

      37

   3. group Id

      BG002

      value

      73

   units

   Participants

groups

1. description

   VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.

   id

   BG000

   title

   Active Comparator: VAD Treatment

2. description

   Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.

   id

   BG001

   title

   Active Comparator: Thalidomide and Dexamethasone Treatment

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            25

         2. group Id

            BG001

            value

            27

         3. group Id

            BG002

            value

            52

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            11

         2. group Id

            BG001

            value

            10

         3. group Id

            BG002

            value

            21

         title

         >=65 years

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Age, Categorical

   unit Of Measure

   Participants

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            15

         2. group Id

            BG001

            value

            14

         3. group Id

            BG002

            value

            29

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            21

         2. group Id

            BG001

            value

            23

         3. group Id

            BG002

            value

            44

         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

            36

         2. group Id

            BG001

            value

            37

         3. group Id

            BG002

            value

            73

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice