Participant flow

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide · Source last updated 2022-05-06

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

groups

1. description

   240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide

   id

   FG000

   title

   Loperamide

2. description

   240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days

   id

   FG001

   title

   Budesonide and Loperamide

3. description

   240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle

   id

   FG002

   title

   Colestipol and Loperamide

4. description

   240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle

   id

   FG003

   title

   Colestipol With Loperamide as Needed

5. description

   120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide

   id

   FG004

   title

   Neratinib Dose Escalation 1

6. description

   160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide

   id

   FG005

   title

   Neratinib Dose Escalation 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         22

      4. group Id

         FG003

         num Subjects

         19

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         8

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         5

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         1

      type

      Other, Disease Progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Other, Decreased Quality of Life

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Other, Noncompliance to Protocol Requirements

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         137

      2. group Id

         FG001

         num Subjects

         64

      3. group Id

         FG002

         num Subjects

         136

      4. group Id

         FG003

         num Subjects

         104

      5. group Id

         FG004

         num Subjects

         60

      6. group Id

         FG005

         num Subjects

         62

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         76

      2. group Id

         FG001

         num Subjects

         52

      3. group Id

         FG002

         num Subjects

         95

      4. group Id

         FG003

         num Subjects

         74

      5. group Id

         FG004

         num Subjects

         45

      6. group Id

         FG005

         num Subjects

         46

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         41

      4. group Id

         FG003

         num Subjects

         30

      5. group Id

         FG004

         num Subjects

         15

      6. group Id

         FG005

         num Subjects

         16

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice