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NCT01363479 · OUTCOME

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

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.

Measure
NUMBER
Unit
percentage of responders
Interval / dispersion
95% Confidence Interval
Time frame
0-24 hours

Analysis population: Full Analysis Set i.e. patients receiving study drugs and chemotherapy

Groups in this outcome

Oral Palonosteron Plus Dexamethasone

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

I.V. Palonosetron Plus Dexamethasone

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

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

Analysis denominator · Participants

GroupSource count
Oral Palonosteron Plus Dexamethasone369
I.V. Palonosetron Plus Dexamethasone369

Reported measurements

Source class 1
Values in percentage of responders · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Oral Palonosteron Plus Dexamethasone89.4Not reported85.992.2Not reported
I.V. Palonosetron Plus Dexamethasone86.2Not reported82.389.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -2.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    9.17
    estimate Comment
    The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
    param Type
    Risk Difference (RD)
    param Value
    3.21
Complete source fields
analyses
  1. ci Lower Limit
    -2.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    9.17
    estimate Comment
    The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
    param Type
    Risk Difference (RD)
    param Value
    3.21
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        85.9
        upper Limit
        92.2
        value
        89.4
      2. group Id
        OG001
        lower Limit
        82.3
        upper Limit
        89.3
        value
        86.2
denoms
  1. counts
    1. group Id
      OG000
      value
      369
    2. group Id
      OG001
      value
      369
    units
    Participants
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    I.V. Palonosetron Plus Dexamethasone
param Type
NUMBER
population Description
Full Analysis Set i.e. patients receiving study drugs and chemotherapy
reporting Status
POSTED
time Frame
0-24 hours
title
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication
type
PRIMARY
unit Of Measure
percentage of responders

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

Preserved source evidence · Not medical advice