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NCT00148317 · ADVERSE EVENTS

Adverse events

Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma · Source last updated 2017-07-18

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
Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment).
Other-event reporting threshold
5%

Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment Arm (All Patients)

Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles

1 / 3838 / 38Not reported / Not reported

Group identifiers: EG000: Treatment Arm (All Patients)

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    term
    diarrhea

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
    notes
    DOVED consolidation phase
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      38
    term
    dizziness
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      38
    term
    insomnia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      38
    term
    depression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      38
    term
    anxiety
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    irritability
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    nervousness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    dry skin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    term
    pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      38
    term
    cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    term
    sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      38
    term
    shortness of breath
Complete source fields
description
Safety was monitored throughout the study and adverse events (AEs) were graded by NCI-CTCAE version 3.0.
event Groups
  1. description
    Bortezomib, Dexamethasone, Pegylated Liposomal Doxorubicin, Cyclophosphamide: Bortezomib 1.3 mg/m2 days 1, 4, 8, 11 (initial cycles) Dexamethasone 40 mg Days 1-4, 8-11, 15-18 (initial cycles) Doxil 30 mg/m2 Day 4 of subsequent cycles
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    1
    serious Num At Risk
    38
    title
    Treatment Arm (All Patients)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      38
    term
    dizziness
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      38
    term
    insomnia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      38
    term
    depression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      38
    term
    anxiety
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    irritability
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    nervousness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    term
    dry skin
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    term
    pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      38
    term
    cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    term
    sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DOVED consolidation phase
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      38
    term
    shortness of breath
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    term
    diarrhea
time Frame
Safety was monitored throughout the study, from start of study until when patients were removed (for either progression, toxicity, or to get a HD-SCT, which occurred up to 1 year after start of treatment).

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