Baseline characteristics

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer · Source last updated 2017-02-13

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

      86

   units

   Participants

groups

1. description

   Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.

   id

   BG000

   title

   Dexamethasone Based Mouthwash

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            10.921

            value

            61.02

   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

            86

      title

      Female

   param Type

   NUMBER

   title

   Sex/Gender, Customized

   unit Of Measure

   Participants

population Description

Full analysis set: The full analysis set consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).

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

Preserved source evidence · Not medical advice