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NCT00600353 · OUTCOME

Overall Emetic Response: Acute

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
24 hours after chemotherapy

What was measured

Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.

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 Myeloma5Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma9Not reportedNot reportedNot reportedNot reported
CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A - Subjects With Multiple Myeloma1Not 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 Myeloma3Not 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 Myeloma0Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma0Not 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 Myeloma9Not reportedNot reportedNot reportedNot reported
Group B - Subjects With Relpased Lymphoma9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        9
    title
    CC
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    CR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    MR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    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
        9
      2. group Id
        OG001
        value
        9
    title
    NSN
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Complete Control (CC) - no emetic episode in 24 hours, no rescue medications and nausea visual scale (NVS) of ≤ 2.5, Complete Emetic Response (CR) - 0 emetic episodes, no rescue medications. Major Emetic Response (MR) - 0 to 2 emetic episodes within 24 hour period with or without rescue medications. Minor Emetic Response (mR) - 3 to 5 emetic episodes within 24 hour period with or without rescue medications. Failure - \>5 emetic episodes within 24 hour period. No Significant Nausea (NSN) - maximum NVS ≤ 5.
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
24 hours after chemotherapy
title
Overall Emetic Response: Acute
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice