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NCT01085214 · OUTCOME

Incidence of Toxicity That May Be Treatment Emergent

AZD6244 (Selumetinib) in Treating Patients With Multiple Myeloma · Source last updated 2015-08-19

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
1 year, 11 months

What was measured

Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).

Analysis population: All participants who received study treatment

Groups in this outcome

AZD6244 (Selumetinib) Treatment

Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
AZD6244 (Selumetinib) Treatment36

Reported measurements

Hematologic - Any Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD6244 (Selumetinib) Treatment6Not reportedNot reportedNot reportedNot reported
Hematologic - Any Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD6244 (Selumetinib) Treatment2Not reportedNot reportedNot reportedNot reported
Hematologic - Any Grade 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD6244 (Selumetinib) Treatment0Not reportedNot reportedNot reportedNot reported
Non-Hematologic - Any Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD6244 (Selumetinib) Treatment14Not reportedNot reportedNot reportedNot reported
Non-Hematologic - Any Grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD6244 (Selumetinib) Treatment1Not reportedNot reportedNot reportedNot reported
Non-Hematologic - Any Grade 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AZD6244 (Selumetinib) Treatment3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Hematologic - Any Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hematologic - Any Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hematologic - Any Grade 5
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Non-Hematologic - Any Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non-Hematologic - Any Grade 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Non-Hematologic - Any Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
groups
  1. description
    Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    AZD6244 (Selumetinib) Treatment
param Type
NUMBER
population Description
All participants who received study treatment
reporting Status
POSTED
time Frame
1 year, 11 months
title
Incidence of Toxicity That May Be Treatment Emergent
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice