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NCT01646762 · OUTCOME

Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2017-10-16

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 3 years

What was measured

Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.

Groups in this outcome

Treatment (Chemotherapy)

Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy)13

Reported measurements

White blood cell decreased
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)30.8Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)38.5Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)38.5Not reportedNot reportedNot reportedNot reported
Fatigue
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)23.1Not reportedNot reportedNot reportedNot reported
Anemia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)15.4Not reportedNot reportedNot reportedNot reported
Anorexia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)7.7Not reportedNot reportedNot reportedNot reported
Edema limbs
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)7.7Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)15.4Not reportedNot reportedNot reportedNot reported
Epistaxis
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)7.7Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)7.7Not reportedNot reportedNot reportedNot reported
Infections and infestations
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)7.7Not reportedNot reportedNot reportedNot reported
Lung infection
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy)7.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30.8
    title
    White blood cell decreased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        38.5
    title
    Neutrophil count decreased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        38.5
    title
    Platelet count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        23.1
    title
    Fatigue
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15.4
    title
    Anemia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        7.7
    title
    Anorexia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7.7
    title
    Edema limbs
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        15.4
    title
    Hyponatremia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        7.7
    title
    Epistaxis
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        7.7
    title
    Febrile neutropenia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        7.7
    title
    Infections and infestations
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        7.7
    title
    Lung infection
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.
groups
  1. description
    Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
    id
    OG000
    title
    Treatment (Chemotherapy)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 3 years
title
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice