Participant flow

A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma · Source last updated 2017-08-09

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

groups

1. description

   Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.

   id

   FG000

   title

   Carboplatin and Gemcitabine + Placebo

2. description

   Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m\^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.

   id

   FG001

   title

   Carboplatin and Gemcitabine + Bevacizumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         58

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      type

      Clinical Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         168

      2. group Id

         FG001

         num Subjects

         109

      type

      Disease Progression Per RECIST

   4. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         27

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Sponsor's Decision To Terminate Study

   6. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         29

      type

      Subject's Decision-Discontinue Treatment

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Did not Receive Treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         242

      2. group Id

         FG001

         num Subjects

         242

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         13

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         242

      2. group Id

         FG001

         num Subjects

         229

      type

      NOT COMPLETED

   title

   Blinded Treatment Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      type

      Disease Progression Per RECIST

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         One participant did not continue into the open-label treatment phase.

         group Id

         FG001

         num Subjects

         12

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Open-label Treatment Phase

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

Preserved source evidence · Not medical advice