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NCT01849848 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
up to around 44 weeks

What was measured

Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.

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

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SyB L-0501243.0Not reported185.0NAThe upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG000
        lower Limit
        185.0
        upper Limit
        NA
        value
        243.0
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.
dispersion Type
95% Confidence Interval
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
MEDIAN
reporting Status
POSTED
time Frame
up to around 44 weeks
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice