Baseline characteristics

CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma · Source last updated 2023-08-22

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

      21

   units

   Participants

groups

1. description

   CC486 +CHOP CC-486 Administration: CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day. CHOP Administration: CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5

   id

   BG000

   title

   CC486 +CHOP

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            9

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            12

         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

            8

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            13

         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

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            19

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            0

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            1

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            1

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            14

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            5

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            21

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

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Preserved source evidence · Not medical advice