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NCT02619812 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
30 days
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group A: SBI + Placebo

SBI 10 grams + placebo twice per day.

0 / 00 / 0Not reported / Not reported
Group B: Colesevelam + Placebo

Colesevelam 1.875 g + Placebo twice per day

0 / 00 / 0Not reported / Not reported
Group C: Colesevelam + SBI

Colesevelam 1.875 g + SBI 10 grams twice per day.

0 / 11 / 1Not reported / Not reported
Group D: Double Placebo

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).

0 / 22 / 2Not reported / Not reported

Group identifiers: EG000: Group A: SBI + Placebo · EG001: Group B: Colesevelam + Placebo · EG002: Group C: Colesevelam + SBI · EG003: Group D: Double Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      Nausea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Vomiting
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Fatigue
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Stomach cramps
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Constipation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Testicular pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        1
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        2
        num Events
        0
      term
      Abdominal bloating
    Complete source fields
    event Groups
    1. description
      SBI 10 grams + placebo twice per day.
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Group A: SBI + Placebo
    2. description
      Colesevelam 1.875 g + Placebo twice per day
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Group B: Colesevelam + Placebo
    3. description
      Colesevelam 1.875 g + SBI 10 grams twice per day.
      id
      EG002
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      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
      EG003
      other Num Affected
      2
      other Num At Risk
      2
      serious Num Affected
      0
      serious Num At Risk
      2
      title
      Group D: Double Placebo
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        2
        num At Risk
        2
        num Events
        2
      term
      Nausea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Vomiting
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Fatigue
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Stomach cramps
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Constipation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        1
        num Events
        0
      4. group Id
        EG003
        num Affected
        1
        num At Risk
        2
        num Events
        1
      term
      Testicular pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        0
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        1
        num Events
        1
      4. group Id
        EG003
        num Affected
        0
        num At Risk
        2
        num Events
        0
      term
      Abdominal bloating
    time Frame
    30 days

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice