Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01339260 · OUTCOME

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting · Source last updated 2014-11-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of responders
Interval / dispersion
95% Confidence Interval
Time frame
25-120 hours

Analysis population: FAS

Groups in this outcome

Netupitant and Palonosetron Plus Dexamethasone

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone

Palonosetron Plus Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle Palonosetron Dexamethasone

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

Analysis denominator · Participants

GroupSource count
Netupitant and Palonosetron Plus Dexamethasone724
Palonosetron Plus Dexamethasone725

Reported measurements

Source class 1
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Netupitant and Palonosetron Plus Dexamethasone76.9Not reported73.779.9Not reported
Palonosetron Plus Dexamethasone69.5Not reported66.172.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.16
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.87
    estimate Comment
    Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.
    group Description
    The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    p Value Comment
    If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050
    param Type
    Odds Ratio (OR)
    param Value
    1.48
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.16
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.87
    estimate Comment
    Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.
    group Description
    The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.001
    p Value Comment
    If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050
    param Type
    Odds Ratio (OR)
    param Value
    1.48
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.7
        upper Limit
        79.9
        value
        76.9
      2. group Id
        OG001
        lower Limit
        66.1
        upper Limit
        72.8
        value
        69.5
denoms
  1. counts
    1. group Id
      OG000
      value
      724
    2. group Id
      OG001
      value
      725
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone
    id
    OG000
    title
    Netupitant and Palonosetron Plus Dexamethasone
  2. description
    Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle Palonosetron Dexamethasone
    id
    OG001
    title
    Palonosetron Plus Dexamethasone
param Type
NUMBER
population Description
FAS
reporting Status
POSTED
time Frame
25-120 hours
title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1
type
PRIMARY
unit Of Measure
percentage of responders

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

Preserved source evidence · Not medical advice