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NCT00531453 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma · Source last updated 2012-01-26

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
From first dose to 30 days post last dose
Other-event reporting threshold
0%

Treatment emergent

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Three Drug Regimen (VDT)

bortezomib, dexamethasone, and thalidomide

11 / 4948 / 49Not reported / Not reported
Four Drug Regimen (VDTC)

bortezomib, dexamethasone, thalidomide, and cyclophosphamide

20 / 4947 / 49Not reported / Not reported

Group identifiers: EG000: Three Drug Regimen (VDT) · EG001: Four Drug Regimen (VDTC)

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
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      49
    term
    Infections and Infestations
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    Gastrointestinal Disorders
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    General Disorders and administration site Conditions
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      49
    term
    Musculoskeletal and Connective Tissue Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    Respiratory, Thoracic and mediastinal Disorders
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Nervous System Disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Blood and Lymphatic System Disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Cardiac Disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Injury, Poisoning and Procedural Complications
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Metabolism and Nutritional Disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Psychiatric Disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Renal and Urinary Disorders

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
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      49
    term
    Gastrointestinal Disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      49
    term
    General Disorders and Administration Site Conditions
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      49
    term
    Nervous System Disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      49
    term
    Blood and Lymphatic System Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      49
    term
    Musculoskeletal and Connective Tissue Disorders
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      49
    term
    Infections and Infestations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      49
    term
    Metabolism and Nutrition Disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      49
    term
    Skin and Subcutaneous Tissue Disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      49
    term
    Respiratory, Thoracic and Mediastinal Disorders
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      49
    term
    Vascular Disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      49
    term
    Psychiatric Disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      49
    term
    Eye Disorders
Complete source fields
description
Treatment emergent
event Groups
  1. description
    bortezomib, dexamethasone, and thalidomide
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    49
    serious Num Affected
    11
    serious Num At Risk
    49
    title
    Three Drug Regimen (VDT)
  2. description
    bortezomib, dexamethasone, thalidomide, and cyclophosphamide
    id
    EG001
    other Num Affected
    47
    other Num At Risk
    49
    serious Num Affected
    20
    serious Num At Risk
    49
    title
    Four Drug Regimen (VDTC)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      49
    term
    Gastrointestinal Disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      49
    term
    General Disorders and Administration Site Conditions
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      49
    term
    Nervous System Disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      49
    term
    Blood and Lymphatic System Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      49
    term
    Musculoskeletal and Connective Tissue Disorders
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      49
    term
    Infections and Infestations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      49
    term
    Metabolism and Nutrition Disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      49
    term
    Skin and Subcutaneous Tissue Disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      49
    term
    Respiratory, Thoracic and Mediastinal Disorders
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      49
    term
    Vascular Disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      49
    term
    Psychiatric Disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      49
    term
    Eye Disorders
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      49
    term
    Infections and Infestations
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    Gastrointestinal Disorders
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    General Disorders and administration site Conditions
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      49
    term
    Musculoskeletal and Connective Tissue Disorders
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      49
    term
    Respiratory, Thoracic and mediastinal Disorders
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Nervous System Disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Blood and Lymphatic System Disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Cardiac Disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      49
    term
    Injury, Poisoning and Procedural Complications
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Metabolism and Nutritional Disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      49
    term
    Psychiatric Disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (11.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      49
    term
    Renal and Urinary Disorders
time Frame
From first dose to 30 days post last dose

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