Baseline characteristics

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18

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

      622

   2. group Id

      BG001

      value

      308

   3. group Id

      BG002

      value

      930

   units

   Participants

groups

1. description

   Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.

   id

   BG000

   title

   Relugolix

2. description

   Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.

   id

   BG001

   title

   Leuprolide Acetate

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            7.75

            value

            71.2

         2. group Id

            BG001

            spread

            8.03

            value

            71.0

         3. group Id

            BG002

            spread

            7.84

            value

            71.1

   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

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            622

         2. group Id

            BG001

            value

            308

         3. group Id

            BG002

            value

            930

         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

            52

         2. group Id

            BG001

            value

            31

         3. group Id

            BG002

            value

            83

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            558

         2. group Id

            BG001

            value

            269

         3. group Id

            BG002

            value

            827

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            12

         2. group Id

            BG001

            value

            8

         3. group Id

            BG002

            value

            20

         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

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            127

         2. group Id

            BG001

            value

            71

         3. group Id

            BG002

            value

            198

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            30

         2. group Id

            BG001

            value

            16

         3. group Id

            BG002

            value

            46

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            434

         2. group Id

            BG001

            value

            202

         3. group Id

            BG002

            value

            636

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            11

         2. group Id

            BG001

            value

            4

         3. group Id

            BG002

            value

            15

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            20

         2. group Id

            BG001

            value

            15

         3. group Id

            BG002

            value

            35

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

population Description

All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.

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Preserved source evidence · Not medical advice