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NCT01179490 · OUTCOME

Duration of Response (DOR)

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
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
Up to 2 years

What was measured

DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.

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

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SyB L-0501 + Prednisolone162.0Not reported99252Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99
        upper Limit
        252
        value
        162.0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.
dispersion Type
Full Range
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
MEDIAN
reporting Status
POSTED
time Frame
Up to 2 years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice