Baseline characteristics

An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2021-09-22

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

      370

   2. group Id

      BG001

      value

      369

   3. group Id

      BG002

      value

      739

   units

   Participants

groups

1. description

   Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. Oral palonosetron Dexamethasone

   id

   BG000

   title

   Oral Palonosteron Plus Dexamethasone

2. description

   Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4. I.V. palonosetron Dexamethasone

   id

   BG001

   title

   I.V. Palonosetron Plus Dexamethasone

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            9.41

            value

            58.0

         2. group Id

            BG001

            spread

            9.92

            value

            57.7

         3. group Id

            BG002

            spread

            9.66

            value

            57.9

   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

            151

         2. group Id

            BG001

            value

            152

         3. group Id

            BG002

            value

            303

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            219

         2. group Id

            BG001

            value

            217

         3. group Id

            BG002

            value

            436

         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

            321

         2. group Id

            BG001

            value

            320

         3. group Id

            BG002

            value

            641

      title

      White

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            49

         2. group Id

            BG001

            value

            47

         3. group Id

            BG002

            value

            96

      title

      Asian

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      Hispanic

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      Other

   param Type

   NUMBER

   title

   Race/Ethnicity, Customized

   unit Of Measure

   participants

population Description

Safety population ie patients receiving either oral or IV palonosetron plus dexamethasone

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Preserved source evidence · Not medical advice