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NCT02477215 · ADVERSE EVENTS

Adverse events

Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2020-10-22

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
3 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bendamustine (70 mg/m^2), MLN9708 and Dexamethasone

MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine: 70 mg/m\^2 on days 1 and 2

2 / 30 / 32 / 3
Bendamustine (80 mg/m^2), MLN9708 and Dexamethasone

MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine: 80 mg/m\^2 on days 1 and 2. This reporting group includes subjects from both the Dose Escalation and Fixed Dose Phases who received Bendamustine at 80 mg/m\^2.

8 / 190 / 198 / 19
Bendamustine (90 mg/m^2), MLN9708 and Dexamethasone

MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine: 90 mg/m\^2 on days 1 and 2

0 / 60 / 62 / 6

Group identifiers: EG000: Bendamustine (70 mg/m^2), MLN9708 and Dexamethasone · EG001: Bendamustine (80 mg/m^2), MLN9708 and Dexamethasone · EG002: Bendamustine (90 mg/m^2), MLN9708 and Dexamethasone

Serious 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
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fecal incontinence
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Urinary incontinence
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Mobitz type 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fall
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Respiratory failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pneumonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pain in extremity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.03
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Exacerbated COPD

Other reported adverse events

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

    Complete source fields
    event Groups
    1. deaths Num Affected
      2
      deaths Num At Risk
      3
      description
      MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine: 70 mg/m\^2 on days 1 and 2
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      3
      serious Num Affected
      2
      serious Num At Risk
      3
      title
      Bendamustine (70 mg/m^2), MLN9708 and Dexamethasone
    2. deaths Num Affected
      8
      deaths Num At Risk
      19
      description
      MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine: 80 mg/m\^2 on days 1 and 2. This reporting group includes subjects from both the Dose Escalation and Fixed Dose Phases who received Bendamustine at 80 mg/m\^2.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      19
      serious Num Affected
      8
      serious Num At Risk
      19
      title
      Bendamustine (80 mg/m^2), MLN9708 and Dexamethasone
    3. deaths Num Affected
      2
      deaths Num At Risk
      6
      description
      MLN9708: 4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. Dexamethasone: 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Bendamustine: 90 mg/m\^2 on days 1 and 2
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      Bendamustine (90 mg/m^2), MLN9708 and Dexamethasone
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Fecal incontinence
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Arthralgia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Urinary incontinence
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Mobitz type 1
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Non-cardiac chest pain
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        19
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Sepsis
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Fall
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Respiratory failure
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        19
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Colitis
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Pneumonitis
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Pain in extremity
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE v4.03
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        3
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        19
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
        num Events
        0
      term
      Exacerbated COPD
    time Frame
    3 years

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

    Preserved source evidence · Not medical advice