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NCT02619812 · FLOW

Participant flow

Manage Diarrhea in Patients With Multiple Myeloma While Receiving Conditioning Chemotherapy for Autologous SCT · Source last updated 2017-06-14

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

groups
  1. description
    SBI 10 grams + placebo twice per day.
    id
    FG000
    title
    Group A: SBI + Placebo
  2. description
    Colesevelam 1.875 g + Placebo twice per day
    id
    FG001
    title
    Group B: Colesevelam + Placebo
  3. description
    Colesevelam 1.875 g + SBI 10 grams twice per day.
    id
    FG002
    title
    Group C: Colesevelam + SBI
  4. description
    Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
    id
    FG003
    title
    Group D: Double Placebo
periods
  1. drop Withdraws
    1. 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
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      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
        2
      type
      STARTED
    2. achievements
      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
        0
      type
      COMPLETED
    3. achievements
      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
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 4 subjects were enrolled. Two subjects were randomized to placebo/placebo, and one subject was randomized to colesevelam/Serum-derived bovine immunoglobulin/protein isolate (SBI). One subject was consented, but never randomized/accrued.
recruitment Details
The subjects were recruited from Mayo Clinic in Rochester, Minnesota.
Complete source fields
groups
  1. description
    SBI 10 grams + placebo twice per day.
    id
    FG000
    title
    Group A: SBI + Placebo
  2. description
    Colesevelam 1.875 g + Placebo twice per day
    id
    FG001
    title
    Group B: Colesevelam + Placebo
  3. description
    Colesevelam 1.875 g + SBI 10 grams twice per day.
    id
    FG002
    title
    Group C: Colesevelam + SBI
  4. description
    Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
    id
    FG003
    title
    Group D: Double Placebo
periods
  1. drop Withdraws
    1. 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
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      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
        2
      type
      STARTED
    2. achievements
      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
        0
      type
      COMPLETED
    3. achievements
      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
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 4 subjects were enrolled. Two subjects were randomized to placebo/placebo, and one subject was randomized to colesevelam/Serum-derived bovine immunoglobulin/protein isolate (SBI). One subject was consented, but never randomized/accrued.
recruitment Details
The subjects were recruited from Mayo Clinic in Rochester, Minnesota.

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Preserved source evidence · Not medical advice