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NCT01179490 · OUTCOME

Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values

Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma · Source last updated 2013-03-18

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
Up to 2 years

What was measured

Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using 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 AE

Groups in this outcome

SyB L-0501 + Prednisolone

SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.

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-0501 + Prednisolone5

Reported measurements

Subjects with Grade 3 abnormality
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-0501 + Prednisolone5Not reportedNot reportedNot reportedNot reported
Subjects with Grade 4 abnormality
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-0501 + Prednisolone5Not reportedNot reportedNot reportedNot reported
Subjects with Grade 5 abnormality
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-0501 + Prednisolone0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Subjects with Grade 3 abnormality
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Subjects with Grade 4 abnormality
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Subjects with Grade 5 abnormality
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using 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 AE
groups
  1. description
    SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
    id
    OG000
    title
    SyB L-0501 + Prednisolone
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years
title
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice