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NCT01441973 · OUTCOME

Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality

Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma · Source last updated 2018-01-23

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
From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months

What was measured

Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.

Analysis population: All participants who received at least 1 dose of study drug

Groups in this outcome

Elotuzumab, 20 mg/kg

Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.

Elotuzumab, 10 mg/kg

Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.

Elotuzumab, All Dosages

All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms

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

Analysis denominator · Participants

GroupSource count
Elotuzumab, 20 mg/kg15
Elotuzumab, 10 mg/kg16
Elotuzumab, All Dosages22

Reported measurements

Lymphocytes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab, 20 mg/kg2Not reportedNot reportedNot reportedNot reported
Elotuzumab, 10 mg/kg1Not reportedNot reportedNot reportedNot reported
Elotuzumab, All Dosages3Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab, 20 mg/kg1Not reportedNot reportedNot reportedNot reported
Elotuzumab, 10 mg/kg1Not reportedNot reportedNot reportedNot reported
Elotuzumab, All Dosages2Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab, 20 mg/kg0Not reportedNot reportedNot reportedNot reported
Elotuzumab, 10 mg/kg1Not reportedNot reportedNot reportedNot reported
Elotuzumab, All Dosages1Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab, 20 mg/kg1Not reportedNot reportedNot reportedNot reported
Elotuzumab, 10 mg/kg2Not reportedNot reportedNot reportedNot reported
Elotuzumab, All Dosages3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Lymphocytes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Hyponatremia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Hyperkalemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
    title
    Hyperglycemia
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      22
    units
    Participants
description
Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.
groups
  1. description
    Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
    id
    OG000
    title
    Elotuzumab, 20 mg/kg
  2. description
    Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
    id
    OG001
    title
    Elotuzumab, 10 mg/kg
  3. description
    All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
    id
    OG002
    title
    Elotuzumab, All Dosages
param Type
NUMBER
population Description
All participants who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months
title
Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice