Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00719901 · ADVERSE EVENTS

Adverse events

Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2015-01-12

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Enzyme Inhibitor Therapy)

Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

3 / 1010 / 10Not reported / Not reported

Group identifiers: EG000: Treatment (Enzyme Inhibitor Therapy)

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
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Depressed level of consciousness

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 10
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      10
      num Events
      36
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cardiac disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Diplopia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      10
      num Events
      12
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      7
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      6
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypersensitivity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
      num Events
      27
    term
    Leukocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Lymphocyte count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
      num Events
      26
    term
    Neutrophil count decreased
Complete source fields
event Groups
  1. description
    Patients receive obatoclax mesylate IV over 3 hours and bortezomib (1.3 mg/m\^2) IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    Treatment (Enzyme Inhibitor Therapy)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      10
      num Events
      36
    term
    Hemoglobin decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cardiac disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Diplopia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      10
      num Events
      12
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      7
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
      num Events
      6
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypersensitivity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
      num Events
      27
    term
    Leukocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Lymphocyte count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      10
      num Events
      26
    term
    Neutrophil count decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Neutrophil count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Depressed level of consciousness

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

Preserved source evidence · Not medical advice