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NCT01849848 · OUTCOME

Adverse Events

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
participants
Interval / dispersion
Not reported
Time frame
up to around 44 weeks

What was measured

All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.

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

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-050117Not reportedNot reportedNot reportedNot reported
Adverse drug reaction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-050117Not reportedNot reportedNot reportedNot reported
SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05014Not reportedNot reportedNot reportedNot reported
Death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05010Not reportedNot reportedNot reportedNot reported
Discontinuation due to adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SyB L-05011Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Adverse drug reaction
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    SAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Death
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Discontinuation due to adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.
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
Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice