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NCT00920855 · ADVERSE EVENTS

Adverse events

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2012-10-04

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
up to 8.5 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bendamustine 50 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

0 / 55 / 5Not reported / Not reported
Bendamustine 70 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

1 / 44 / 4Not reported / Not reported
Bendamustine 90 mg/m^2 Cohort

Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.

7 / 3131 / 31Not reported / Not reported

Group identifiers: EG000: Bendamustine 50 mg/m^2 Cohort · EG001: Bendamustine 70 mg/m^2 Cohort · EG002: Bendamustine 90 mg/m^2 Cohort

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Cystitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Sepsis syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Musculoskeletal chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Renal failure

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      31
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      31
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      31
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      31
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      31
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Adrenal insufficiency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Eye irritation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Scleral hyperaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      31
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Anal fissure
Complete source fields
event Groups
  1. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Bendamustine 50 mg/m^2 Cohort
  2. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Bendamustine 70 mg/m^2 Cohort
  3. description
    Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
    id
    EG002
    other Num Affected
    31
    other Num At Risk
    31
    serious Num Affected
    7
    serious Num At Risk
    31
    title
    Bendamustine 90 mg/m^2 Cohort
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      31
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      31
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      31
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      31
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      31
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Adrenal insufficiency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Eye irritation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Scleral hyperaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      31
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
    term
    Anal fissure
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
    term
    Pyrexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Cystitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Pneumonia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Sepsis syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Dehydration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Back pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Musculoskeletal chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (13.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
    term
    Renal failure
time Frame
up to 8.5 months

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

Preserved source evidence · Not medical advice