Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01343277 · OUTCOME

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma · Source last updated 2016-08-26

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
approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])

What was measured

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Analysis population: Safety population included all the treated participants.

Groups in this outcome

Trabectedin

Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.

Dacarbazine

Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine 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
Trabectedin378
Dacarbazine172

Reported measurements

Serious Adverse Events (SAEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trabectedin155Not reportedNot reportedNot reportedNot reported
Dacarbazine52Not reportedNot reportedNot reportedNot reported
Adverse Events (AEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trabectedin375Not reportedNot reportedNot reportedNot reported
Dacarbazine166Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        155
      2. group Id
        OG001
        value
        52
    title
    Serious Adverse Events (SAEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        375
      2. group Id
        OG001
        value
        166
    title
    Adverse Events (AEs)
denoms
  1. counts
    1. group Id
      OG000
      value
      378
    2. group Id
      OG001
      value
      172
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
groups
  1. description
    Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
    id
    OG000
    title
    Trabectedin
  2. description
    Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
    id
    OG001
    title
    Dacarbazine
param Type
NUMBER
population Description
Safety population included all the treated participants.
reporting Status
POSTED
time Frame
approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])
title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice