Participant flow

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer · Source last updated 2018-09-21

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

groups

1. description

   Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.

   id

   FG000

   title

   Sunitinib

2. description

   Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         18

      type

      Other

   2. reasons

      1. group Id

         FG000

         num Subjects

         67

      2. group Id

         FG001

         num Subjects

         76

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         30

      type

      Participants refused further follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         15

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Enrolled but not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         309

      2. group Id

         FG001

         num Subjects

         306

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         309

      2. group Id

         FG001

         num Subjects

         306

      comment

      All randomized participants, who received study drug/a different drug to which they were randomized

      type

      Intent-to-Treat Population

   3. achievements

      1. comment

         3 were randomized but not treated: 2 refused treatment \& 1 withdrew before receiving study drug

         group Id

         FG000

         num Subjects

         306

      2. comment

         2 were randomized but not treated: 1 was screening failure \& 1 discontinued due to new liver lesions

         group Id

         FG001

         num Subjects

         304

      comment

      All participants, who received at least 1 dose of study drug according to actual study treatment

      type

      As-Treated Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         165

      2. group Id

         FG001

         num Subjects

         165

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         144

      2. group Id

         FG001

         num Subjects

         141

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Screening: From Week 0 (nephrectomy surgery) to Week 11; in this period, echocardiogram/multi-gated acquisition, post-surgery imaging, histopathology, physical examination, laboratory tests, electrocardiogram and concomitant treatment were assessed. Randomization occurred not before 3 weeks post-nephrectomy \& not after 12 weeks post-nephrectomy.

recruitment Details

Of 674 enrolled participants (615 in global cohort and 59 in china cohort), the results presented refers to the study conducted on 615 (intent-to-treat population) in 21 countries and were randomized to sunitinib and placebo for 9 cycles (1 cycle=42 days).

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Preserved source evidence · Not medical advice