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NCT01286077 · ADVERSE EVENTS

Adverse events

Velcade Consolidation Bone Study · Source last updated 2016-05-30

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 the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bortezomib

bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

6 / 5147 / 51Not reported / Not reported
Non-treated Control

no treatment, observation only

3 / 5335 / 53Not reported / Not reported

Group identifiers: EG000: Bortezomib · EG001: Non-treated Control

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Bradycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Influenza like illness
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Pyrexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Acute hepatic failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Device related infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Gastroenteritis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Herpes zoster
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Pneumonia bacterial
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Urinary tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Back pain

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Abdominal pain upper
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Fatigue
Complete source fields
event Groups
  1. description
    bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
    id
    EG000
    other Num Affected
    47
    other Num At Risk
    51
    serious Num Affected
    6
    serious Num At Risk
    51
    title
    Bortezomib
  2. description
    no treatment, observation only
    id
    EG001
    other Num Affected
    35
    other Num At Risk
    53
    serious Num Affected
    3
    serious Num At Risk
    53
    title
    Non-treated Control
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Abdominal pain upper
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Constipation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Dry mouth
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Dyspepsia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Bradycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Influenza like illness
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Pyrexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Acute hepatic failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Device related infection
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Gastroenteritis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Herpes zoster
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
    term
    Pneumonia bacterial
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Urinary tract infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA Version 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      51
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
    term
    Back pain
time Frame
from the time a signed and dated informed consent form is obtained until EOT Visit (24 weeks after randomization) or until the start of subsequent systemic antimyeloma therapy, if earlier

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