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NCT00469209 · ADVERSE EVENTS

Adverse events

Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients · Source last updated 2020-09-24

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
Study period 2 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
No Bortezomib

Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

3 / 204 / 20Not reported / Not reported
Bortezomib 1.0 mg/m^2

Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

2 / 205 / 20Not reported / Not reported
Bortezomib 1.5 mg/m^2

Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

2 / 205 / 20Not reported / Not reported

Group identifiers: EG000: No Bortezomib · EG001: Bortezomib 1.0 mg/m^2 · EG002: Bortezomib 1.5 mg/m^2

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    pneumonitis/death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    acute renal failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    pleural effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    ventriculat tachycardia/hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    small bowel obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    pulmonary embolus

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
      3
      num At Risk
      20
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    dyspnea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    hydronephrosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    pulmonary edema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    low back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    elevated transaminases
Complete source fields
event Groups
  1. description
    Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    20
    serious Num Affected
    3
    serious Num At Risk
    20
    title
    No Bortezomib
  2. description
    Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    20
    serious Num Affected
    2
    serious Num At Risk
    20
    title
    Bortezomib 1.0 mg/m^2
  3. description
    Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    20
    serious Num Affected
    2
    serious Num At Risk
    20
    title
    Bortezomib 1.5 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    mucositis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    dyspnea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    hydronephrosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    pulmonary edema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    low back pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    elevated transaminases
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    pneumonitis/death
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    acute renal failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    pleural effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    term
    ventriculat tachycardia/hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    small bowel obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      20
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    pulmonary embolus
time Frame
Study period 2 years.

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