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NCT01413178 · OUTCOME

Number of Participants That Had Grade 3-4 Toxicities.

A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma · Source last updated 2020-04-21

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
At day 90 post SCT (Stem Cell Transplantation)

Groups in this outcome

Busulfan + Melphalan

Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant

Melphalan

High-dose Melphalan 200 mg/m2/day followed by a 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
Busulfan + Melphalan104
Melphalan98

Reported measurements

Grade 3 - Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan5Not reportedNot reportedNot reportedNot reported
Melphalan4Not reportedNot reportedNot reportedNot reported
Grade 3 - Elevated ALT
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan3Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Elevated Tbili
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan2Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan16Not reportedNot reportedNot reportedNot reported
Melphalan5Not reportedNot reportedNot reportedNot reported
Grade 3 - Mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan15Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan5Not reportedNot reportedNot reportedNot reported
Melphalan2Not reportedNot reportedNot reportedNot reported
Grade 3 - Neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan1Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Neutropenic fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan73Not reportedNot reportedNot reportedNot reported
Melphalan32Not reportedNot reportedNot reportedNot reported
Grade 3 - Pneumonia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan1Not reportedNot reportedNot reportedNot reported
Melphalan1Not reportedNot reportedNot reportedNot reported
Grade 3 - Tachycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan1Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Transient blindness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan1Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Anorexia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan1Not reportedNot reportedNot reportedNot reported
Melphalan0Not reportedNot reportedNot reportedNot reported
Grade 3 - Myocardial ischemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan1Not reportedNot reportedNot reportedNot reported
Melphalan1Not reportedNot reportedNot reportedNot reported
Grade 3 - Pleural effusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan0Not reportedNot reportedNot reportedNot reported
Melphalan1Not reportedNot reportedNot reportedNot reported
Grade 3 - Rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan0Not reportedNot reportedNot reportedNot reported
Melphalan1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
    title
    Grade 3 - Diarrhea
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Elevated ALT
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Elevated Tbili
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        5
    title
    Grade 3 - Infection
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Mucositis
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Grade 3 - Nausea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Neuropathy
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        32
    title
    Grade 3 - Neutropenic fever
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Grade 3 - Pneumonia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Tachycardia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Transient blindness
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Grade 3 - Anorexia
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      98
    units
    Participants
groups
  1. description
    Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant
    id
    OG000
    title
    Busulfan + Melphalan
  2. description
    High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
    id
    OG001
    title
    Melphalan
param Type
NUMBER
reporting Status
POSTED
time Frame
At day 90 post SCT (Stem Cell Transplantation)
title
Number of Participants That Had Grade 3-4 Toxicities.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice