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NCT01849848 · OUTCOME

Number of Abnormalities (Grade ≥3) in Laboratory Test Values

Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma · Source last updated 2015-02-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Events
Interval / dispersion
Not reported
Time frame
up to around 44 weeks

What was measured

Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event

Groups in this outcome

SyB L-0501

SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.

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

Analysis denominator · Participants

GroupSource count
SyB L-050117

Reported measurements

CD4 lymphocytes decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-050114Not reportedNot reportedNot reportedNot reported
Electrocardiogram QT corrected interval prolonged
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05011Not reportedNot reportedNot reportedNot reported
Investigations - Other, sodium decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05012Not reportedNot reportedNot reportedNot reported
Investigations - Other, potassium decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05012Not reportedNot reportedNot reportedNot reported
Investigations - Other, calcium increased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05011Not reportedNot reportedNot reportedNot reported
Investigations - Other, Haemoglobin decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05012Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-050133Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-050115Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05013Not reportedNot reportedNot reportedNot reported
Weight increased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05011Not reportedNot reportedNot reportedNot reported
White blood cell decreased
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-050117Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    CD4 lymphocytes decreased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Electrocardiogram QT corrected interval prolonged
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Investigations - Other, sodium decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Investigations - Other, potassium decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Investigations - Other, calcium increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Investigations - Other, Haemoglobin decreased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    title
    Lymphocyte count decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Neutrophil count decreased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Platelet count decreased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Weight increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    White blood cell decreased
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event
groups
  1. description
    SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
    id
    OG000
    title
    SyB L-0501
param Type
NUMBER
reporting Status
POSTED
time Frame
up to around 44 weeks
title
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
type
SECONDARY
unit Of Measure
Events

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

Preserved source evidence · Not medical advice