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NCT02069093 · OUTCOME

Number of Participants With Stomatitis Grade ≥ 2

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.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
56 days

What was measured

The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.

Analysis population: Full analysis set (FAS): The FAS 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).

Groups in this outcome

Dexamethasone Based Mouthwash

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dexamethasone Based Mouthwash86

Reported measurements

Stomatitis grade >=2: Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash2Not reportedNot reportedNot reportedNot reported
Stomatitis grade >=2: No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash83Not reportedNot reportedNot reportedNot reported
Stomatitis grade >=2: Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash1Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    statistical Method
    Incidence rate R
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    statistical Method
    Incidence rate R
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stomatitis grade >=2: Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        83
    title
    Stomatitis grade >=2: No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stomatitis grade >=2: Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.
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
    OG000
    title
    Dexamethasone Based Mouthwash
param Type
NUMBER
population Description
Full analysis set (FAS): The FAS 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).
reporting Status
POSTED
time Frame
56 days
title
Number of Participants With Stomatitis Grade ≥ 2
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice