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NCT00600353 · OUTCOME

Overall Emetic Response

Multi-day Doses in Prevention of Nausea and Emesis · Source last updated 2017-03-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At leaset 24 hours to more than 72 hours after chemotherapy

What was measured

Clinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.

Groups in this outcome

Group A - Subjects With Multiple Myeloma

Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion

Group B - Subjects With Relpased Lymphoma

Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant

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

Analysis denominator · Participants

GroupSource count
Group A - Subjects With Multiple Myeloma9
Group B - Subjects With Relpased Lymphoma9

Reported measurements

CC
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma1Not reportedNot reportedNot reportedNot reported
CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma0Not reportedNot reportedNot reportedNot reported
MR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma8Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma6Not reportedNot reportedNot reportedNot reported
mR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma1Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma2Not reportedNot reportedNot reportedNot reported
Failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma0Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma0Not reportedNot reportedNot reportedNot reported
NSN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma6Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    CC
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    CR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
    title
    MR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    mR
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Failure
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
    title
    NSN
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Clinical responses were summarized using frequencies and percentages by phase, disease group, and overall. To compute emetic response by phase, the previously defined criteria were applied to each day of the three phases independently. The worst response was used to represent the response in each of these phases and overall emetic response. Overall emetic response was computed by applying the same definitions of emetic response to the entire study period.
groups
  1. description
    Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion
    id
    OG000
    title
    Group A - Subjects With Multiple Myeloma
  2. description
    Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * carmustin (BCNU) 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
    id
    OG001
    title
    Group B - Subjects With Relpased Lymphoma
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At leaset 24 hours to more than 72 hours after chemotherapy
title
Overall Emetic Response
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice