Baseline characteristics

A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia · Source last updated 2017-05-30

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

      15

   2. group Id

      BG001

      value

      22

   3. group Id

      BG002

      value

      37

   units

   Participants

groups

1. description

   Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.

   id

   BG000

   title

   300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5

2. description

   Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.

   id

   BG001

   title

   300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            10.78

            value

            62.3

         2. group Id

            BG001

            spread

            9.36

            value

            64.0

         3. group Id

            BG002

            spread

            9.85

            value

            63.3

   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

            6

         2. group Id

            BG001

            value

            9

         3. group Id

            BG002

            value

            15

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            9

         2. group Id

            BG001

            value

            13

         3. group Id

            BG002

            value

            22

         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

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      African American/African Heritage

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      Asian - East Asian Heritage

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            14

         2. group Id

            BG001

            value

            19

         3. group Id

            BG002

            value

            33

      title

      White - White/Caucasian/European

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            2

      title

      Unknown

   param Type

   NUMBER

   title

   Race/Ethnicity, Customized

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice