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NCT00473590 · ADVERSE EVENTS

Adverse events

A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) · Source last updated 2017-06-14

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
Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.
Other-event reporting threshold
5%

Two patients who were randomized to the BORT + P arm received at least one dose of bevacizumab during the study and were analyzed as bevacizumab-treated patients. Therefore, 50 patients in the BORT + P arm and 50 patients were included in the BORT + BV arm in the safety analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
BORT + P

Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.

26 / 5041 / 50Not reported / Not reported
BORT + BV

Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.

24 / 5043 / 50Not reported / Not reported

Group identifiers: EG000: BORT + P · EG001: BORT + BV

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
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Atrial Flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Pericarditis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Ulcerative Keratitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Lower Gastrointestinal Haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Rectal Haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Rectal Perforation

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
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      50
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      50
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      50
    term
    Neuralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
    term
    Neuropathy Peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      50
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
    term
    Upper Respiratory Tract Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
    term
    Urinary Tract Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    term
    Headache
Complete source fields
description
Two patients who were randomized to the BORT + P arm received at least one dose of bevacizumab during the study and were analyzed as bevacizumab-treated patients. Therefore, 50 patients in the BORT + P arm and 50 patients were included in the BORT + BV arm in the safety analysis.
event Groups
  1. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    50
    serious Num Affected
    26
    serious Num At Risk
    50
    title
    BORT + P
  2. description
    Participants received bortezomib 1.3 mg/m\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
    id
    EG001
    other Num Affected
    43
    other Num At Risk
    50
    serious Num Affected
    24
    serious Num At Risk
    50
    title
    BORT + BV
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      50
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      50
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      50
    term
    Neuralgia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
    term
    Neuropathy Peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      50
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
    term
    Upper Respiratory Tract Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
    term
    Urinary Tract Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      50
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Atrial Flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Pericarditis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Ulcerative Keratitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Lower Gastrointestinal Haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    term
    Rectal Haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    term
    Rectal Perforation
time Frame
Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination.

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