Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00229203 · OUTCOME

Number of Patients With Overall Survival (OS)

A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma · Source last updated 2009-12-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage patients
Interval / dispersion
Not reported
Time frame
Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.

What was measured

Overall Survival (OS): time from the date of first infusion to the date of documented death

Analysis population: Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.

Groups in this outcome

Plitidepsin

Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.

Plitidepsin + Dexamethasone

Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Plitidepsin21
Plitidepsin + Dexamethasone8

Reported measurements

OS at 6 months
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin70Not reported5.131.8Not reported
Plitidepsin + Dexamethasone76Not reported00Not reported
OS at 12 months
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin53Not reportedNot reportedNot reportedNot reported
Plitidepsin + Dexamethasone61Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.1
        upper Limit
        31.8
        value
        70
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        76
    title
    OS at 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        61
    title
    OS at 12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Overall Survival (OS): time from the date of first infusion to the date of documented death
groups
  1. description
    Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
    id
    OG000
    title
    Plitidepsin
  2. description
    Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
    id
    OG001
    title
    Plitidepsin + Dexamethasone
param Type
NUMBER
population Description
Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients. For patient of group plitidepsin + dexamethasone the median overall survival could not be calculated due to follow-up short duration. The survival rates at 6 and 12 months are provided instead.
reporting Status
POSTED
time Frame
Start of treatment to death. At each patient visit while on treatment, then every 3m during follow-up. Median OS and OS rates at 6 months and 12 months were assessed.
title
Number of Patients With Overall Survival (OS)
type
SECONDARY
unit Of Measure
percentage patients

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

Preserved source evidence · Not medical advice