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NCT01441973 · OUTCOME

Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate

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
cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months

What was measured

All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.

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 Dosages31

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elotuzumab, 20 mg/kg0Not reportedNot reportedNot reportedNot reported
Elotuzumab, 10 mg/kg0Not reportedNot reportedNot reportedNot reported
Elotuzumab, All Dosages0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      31
    units
    Participants
description
All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.
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
cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months
title
Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice