Participant flow

Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma · Source last updated 2025-03-30

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

groups

1. description

   Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

   id

   FG000

   title

   Pazopanib 800 mg

2. description

   Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

   id

   FG001

   title

   Sunitinib 50 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      type

      Transitioned to another mechanism of continuing pazopanib or sunitinib therapy after 30SEP2013

   3. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         15

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         12

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         36

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         557

      2. group Id

         FG001

         num Subjects

         553

      comment

      All randomized subjects from Study A2301 and Study A2201 were included in the Intent-to-Treat (ITT) Population

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         554

      2. group Id

         FG001

         num Subjects

         548

      comment

      All randomized subjects from Study A2301 and Study A2201 who received at least one dose of study treatment were included in the Safety Population

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         485

      2. group Id

         FG001

         num Subjects

         481

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         72

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were stratified based on Karnofsky Performance Scale scores (70 or 80; 90 or 100), Baseline levels of lactate dehydrogenase (\>1.5 versus \<=1.5 times the upper limit of normal \[ULN\]), and previous nephrectomy (yes versus no) and were randomized in a 1:1 ratio to receive either pazopanib or sunitinib.

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

Preserved source evidence · Not medical advice