Participant flow

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer · Source last updated 2021-04-27

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

groups

1. description

   Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.

   id

   FG000

   title

   Cohort A: SC Herceptin by Needle/Syringe

2. description

   Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

   id

   FG001

   title

   Cohort B: SC Herceptin by Single-Use Injection Device (SID)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         13

      type

      Disease Progression/Recurrence

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      type

      Investigator/Sponsor Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         2

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      Lack of Compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         100

      2. group Id

         FG001

         num Subjects

         30

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Pregnancy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1867

      2. group Id

         FG001

         num Subjects

         710

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1670

      2. group Id

         FG001

         num Subjects

         652

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         197

      2. group Id

         FG001

         num Subjects

         58

      type

      NOT COMPLETED

   title

   Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Physician Decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         48

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         155

      2. group Id

         FG001

         num Subjects

         49

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      type

      Non-compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Site closure

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Erroneous reporting or late reporting

   9. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Missing

   10. reasons

       1. group Id

          FG000

          num Subjects

          223

       2. group Id

          FG001

          num Subjects

          90

       type

       Disease progression /disease recurrence

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Sponsor decision

   12. reasons

       1. group Id

          FG000

          num Subjects

          8

       2. group Id

          FG001

          num Subjects

          4

       type

       Adverse Event

   milestones

   1. achievements

      1. comment

         Participants who discontinued treatment were allowed to join the SFU Period.

         group Id

         FG000

         num Subjects

         1865

      2. comment

         Participants who discontinued treatment were allowed to join the SFU Period.

         group Id

         FG001

         num Subjects

         708

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1318

      2. group Id

         FG001

         num Subjects

         501

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         547

      2. group Id

         FG001

         num Subjects

         207

      type

      NOT COMPLETED

   title

   Safety Follow-up

pre Assignment Details

Of the 2984 participants screened, a total of 2577 participants were enrolled into the trial, and 2573 participants received at least one dose of study treatment. 4 Participants were not included in the Safety Follow-Up (SFU) ITT due to the lack of Principal Investigator signatures.

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

Preserved source evidence · Not medical advice