Participant flow

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.

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

   FG000

   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

   FG001

   title

   Dacarbazine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Other

   2. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         13

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         67

      2. group Id

         FG001

         num Subjects

         13

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         270

      2. group Id

         FG001

         num Subjects

         138

      type

      Disease progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         21

      type

      Randomized not treated

   8. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      type

      Treatment ongoing

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Subsequent anticancer therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         384

      2. group Id

         FG001

         num Subjects

         193

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         378

      2. group Id

         FG001

         num Subjects

         172

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         384

      2. group Id

         FG001

         num Subjects

         193

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Total enrolled participants were 577, but 2 participants were randomized twice, therefore counted twice in enrollment. Thus, enrolled participants are reported as 579.

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Preserved source evidence · Not medical advice