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NCT01168232 · OUTCOME

Adverse Events (Grade 3 or Higher) During Treatment Period.

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer · Source last updated 2019-08-08

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
During treatment and up to 30 days after stopping the study treatment

What was measured

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0

Analysis population: Eligible and Treated Participants

Groups in this outcome

Ixabepilone

Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment

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

Analysis denominator · Participants

GroupSource count
Ixabepilone34

Reported measurements

Leukopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone15Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone0Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone16Not reportedNot reportedNot reportedNot reported
Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone5Not reportedNot reportedNot reportedNot reported
Other Investigations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone4Not reportedNot reportedNot reportedNot reported
Other Blood/lymphatics
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone2Not reportedNot reportedNot reportedNot reported
Cardiac Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone1Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone6Not reportedNot reportedNot reportedNot reported
General disorders and administration site conditio
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone9Not reportedNot reportedNot reportedNot reported
Infections and infestations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone3Not reportedNot reportedNot reportedNot reported
Metabolism and nutrition disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone12Not reportedNot reportedNot reportedNot reported
Musculoskelatal and connective tissue disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone1Not reportedNot reportedNot reportedNot reported
Neoplasms benign, malignant and unspecified
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone2Not reportedNot reportedNot reportedNot reported
Peripheral sensory neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone1Not reportedNot reportedNot reportedNot reported
Other nervous system disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone2Not reportedNot reportedNot reportedNot reported
Respitory, thoracic and mediastinal disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone5Not reportedNot reportedNot reportedNot reported
Vascular disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixabepilone8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Neutropenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Other Investigations
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Other Blood/lymphatics
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cardiac Disorders
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Gastrointestinal disorders
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    General disorders and administration site conditio
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Infections and infestations
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Metabolism and nutrition disorders
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Musculoskelatal and connective tissue disorders
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0
groups
  1. description
    Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    id
    OG000
    title
    Ixabepilone
param Type
NUMBER
population Description
Eligible and Treated Participants
reporting Status
POSTED
time Frame
During treatment and up to 30 days after stopping the study treatment
title
Adverse Events (Grade 3 or Higher) During Treatment Period.
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice