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NCT00432458 · OUTCOME

Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma · Source last updated 2012-07-04

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 (up to 5 years)

What was measured

Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death

Groups in this outcome

Arm I: Thal/ZLD

Thalidomide (Thal) + Zolendronic acid (ZLD)

Arm II: ZLD

Zoledronic acid (ZLD)

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

Analysis denominator · Participants

GroupSource count
Arm I: Thal/ZLD35
Arm II: ZLD33

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I: Thal/ZLD17Not reportedNot reportedNot reportedNot reported
Arm II: ZLD13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      33
    units
    Participants
description
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 2. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
groups
  1. description
    Thalidomide (Thal) + Zolendronic acid (ZLD)
    id
    OG000
    title
    Arm I: Thal/ZLD
  2. description
    Zoledronic acid (ZLD)
    id
    OG001
    title
    Arm II: ZLD
param Type
NUMBER
reporting Status
POSTED
time Frame
During treatment (up to 5 years)
title
Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice