Baseline characteristics

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia · Source last updated 2019-12-18

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

      196

   2. group Id

      BG001

      value

      195

   3. group Id

      BG002

      value

      391

   units

   Participants

groups

1. description

   An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)

   id

   BG000

   title

   Ofatumumab (Arm A)

2. description

   A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

   id

   BG001

   title

   Ibrutinib (Arm B)

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

            75

         2. group Id

            BG001

            value

            77

         3. group Id

            BG002

            value

            152

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            121

         2. group Id

            BG001

            value

            118

         3. group Id

            BG002

            value

            239

         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

            spread

            8.88

            value

            66.8

         2. group Id

            BG001

            spread

            10.15

            value

            66.1

         3. group Id

            BG002

            spread

            9.53

            value

            66.5

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            59

         2. group Id

            BG001

            value

            66

         3. group Id

            BG002

            value

            125

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            137

         2. group Id

            BG001

            value

            129

         3. group Id

            BG002

            value

            266

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice