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NCT01179490 · OUTCOME

Pharmacokinetic Parameters (Tmax)

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
MEAN
Unit
h
Interval / dispersion
Standard Deviation
Time frame
On Day 1 only

What was measured

Plasma pharmacokinetics (tmax) of unchanged bendamustine

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 h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SyB L-0501 + Prednisolone1.000.00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00
        value
        1.00
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Plasma pharmacokinetics (tmax) of unchanged bendamustine
dispersion Type
Standard Deviation
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
MEAN
reporting Status
POSTED
time Frame
On Day 1 only
title
Pharmacokinetic Parameters (Tmax)
type
SECONDARY
unit Of Measure
h

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

Preserved source evidence · Not medical advice