Participant flow

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy · Source last updated 2016-10-12

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

groups

1. description

   Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.

   id

   FG000

   title

   Trastuzumab Emtansine

2. description

   Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.

   id

   FG001

   title

   Treatment of Physician's Choice

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         247

      2. group Id

         FG001

         num Subjects

         122

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Non-compliance

   4. reasons

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         32

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         34

      type

      Study Completed by Sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Reason Not Specified

   7. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         4

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         404

      2. group Id

         FG001

         num Subjects

         198

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         94

      type

      Switched to Trastuzumab Emtansine

   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

         404

      2. group Id

         FG001

         num Subjects

         198

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 602 patients were randomized to the study (404 to receive Trastuzumab Emtansine and 198 to receive Treatment of Physician's Choice).

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Preserved source evidence · Not medical advice