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NCT00635154 · OUTCOME

Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone

Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma · Source last updated 2018-06-07

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
every cycle during treatment (up to 5 years)

What was measured

Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.

Analysis population: Only participants who received Anakinra with low or high dose dexamethasone were analyzed.

Groups in this outcome

Anakinra With Dexamethasone

Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)

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

Analysis denominator · Participants

GroupSource count
Anakinra With Dexamethasone29

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anakinra With Dexamethasone4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2.
groups
  1. description
    Patients in this outcome received both Anakinra (100mg daily subcutaneously administered) and dexamethasone (either 20mg/week OR 40mg days 1-4, 9-12, 17-20 every 28 days during odd cycles OR 40 mg days 1-4 every 28 days during even cycles)
    id
    OG000
    title
    Anakinra With Dexamethasone
param Type
NUMBER
population Description
Only participants who received Anakinra with low or high dose dexamethasone were analyzed.
reporting Status
POSTED
time Frame
every cycle during treatment (up to 5 years)
title
Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice