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NCT00523848 · ADVERSE EVENTS

Adverse events

Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma · Source last updated 2017-02-23

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
VDT: VELCADE, Doxil and Low-dose Thalidomide

Not reported

16 / 4444 / 44Not reported / Not reported

Group identifiers: EG000: VDT: VELCADE, Doxil and Low-dose Thalidomide

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Febrile neutropenia - Grade 3
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Bradycardia - Grade 2
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Cardiac failure congestive - Grade 3
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Sinus bradycardia - Grade 2
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Hypothyroidism - Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Asthenia - Grade 2
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Chills - Grade 1
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Oedema peripheral - Grade 3
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Pain - Grade 2
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Pyrexia - Grade 1
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Pyrexia - Grade 2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Pyrexia - Grade 3

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
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
      num Events
      9
    term
    Anaemia - Grade 1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      44
      num Events
      9
    term
    Anaemia - Grade 2
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Anaemia - Grade 3
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      44
      num Events
      22
    term
    Leukopenia - Grade 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
      num Events
      15
    term
    Leukopenia - Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
      num Events
      7
    term
    Leukopenia - Grade 3
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      44
      num Events
      14
    term
    Lymphopenia - Grade 1
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      44
      num Events
      15
    term
    Lymphopenia - Grade 2
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
      num Events
      11
    term
    Lymphopenia - Grade 3
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
      num Events
      7
    term
    Neutropenia - Grade 1
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      44
      num Events
      16
    term
    Neutropenia - Grade 2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
      num Events
      9
    term
    Neutropenia - Grade 3
Complete source fields
event Groups
  1. id
    EG000
    other Num Affected
    44
    other Num At Risk
    44
    serious Num Affected
    16
    serious Num At Risk
    44
    title
    VDT: VELCADE, Doxil and Low-dose Thalidomide
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
      num Events
      9
    term
    Anaemia - Grade 1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      44
      num Events
      9
    term
    Anaemia - Grade 2
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Anaemia - Grade 3
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      44
      num Events
      22
    term
    Leukopenia - Grade 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
      num Events
      15
    term
    Leukopenia - Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      44
      num Events
      7
    term
    Leukopenia - Grade 3
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      44
      num Events
      14
    term
    Lymphopenia - Grade 1
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      44
      num Events
      15
    term
    Lymphopenia - Grade 2
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
      num Events
      11
    term
    Lymphopenia - Grade 3
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      44
      num Events
      7
    term
    Neutropenia - Grade 1
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      44
      num Events
      16
    term
    Neutropenia - Grade 2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
      num Events
      9
    term
    Neutropenia - Grade 3
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Febrile neutropenia - Grade 3
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Bradycardia - Grade 2
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Cardiac failure congestive - Grade 3
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Sinus bradycardia - Grade 2
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Hypothyroidism - Grade 2
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Asthenia - Grade 2
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Chills - Grade 1
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Oedema peripheral - Grade 3
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Pain - Grade 2
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    term
    Pyrexia - Grade 1
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Pyrexia - Grade 2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    term
    Pyrexia - Grade 3

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Preserved source evidence · Not medical advice