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NCT02654990 · ADVERSE EVENTS

Adverse events

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma · Source last updated 2024-07-12

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
Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.
Other-event reporting threshold
4.9%

Safety Set: all participants who received any study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A - Panobinostat (20 mg, TIW)

Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

44 / 7878 / 7834 / 78
Arm B - Panobinostat (20 mg, BIW)

Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

40 / 8382 / 8341 / 83
Arm C - Panobinostat (10 mg, TIW)

Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

36 / 8078 / 8047 / 80

Group identifiers: EG000: Arm A - Panobinostat (20 mg, TIW) · EG001: Arm B - Panobinostat (20 mg, BIW) · EG002: Arm C - Panobinostat (10 mg, TIW)

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Bicytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Methaemoglobinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Atrial Fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Atrial Flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Cardiac Failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Cardiac Failure Congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Cardiac Arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Cardiac Failure Acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Myocardial Infarction

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      80
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      80
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      80
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      80
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      80
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      80
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      80
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      80
    term
    Abdominal Pain
Complete source fields
description
Safety Set: all participants who received any study treatment.
event Groups
  1. deaths Num Affected
    34
    deaths Num At Risk
    78
    description
    Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    EG000
    other Num Affected
    78
    other Num At Risk
    78
    serious Num Affected
    44
    serious Num At Risk
    78
    title
    Arm A - Panobinostat (20 mg, TIW)
  2. deaths Num Affected
    41
    deaths Num At Risk
    83
    description
    Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    EG001
    other Num Affected
    82
    other Num At Risk
    83
    serious Num Affected
    40
    serious Num At Risk
    83
    title
    Arm B - Panobinostat (20 mg, BIW)
  3. deaths Num Affected
    47
    deaths Num At Risk
    80
    description
    Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    EG002
    other Num Affected
    78
    other Num At Risk
    80
    serious Num Affected
    36
    serious Num At Risk
    80
    title
    Arm C - Panobinostat (10 mg, TIW)
frequency Threshold
4.9
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      80
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      80
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      80
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      80
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      80
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      80
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      80
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      80
    term
    Abdominal Pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Thrombocytopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Bicytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Methaemoglobinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Atrial Fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Atrial Flutter
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      80
    term
    Cardiac Failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Cardiac Failure Congestive
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Cardiac Arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      80
    term
    Cardiac Failure Acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      80
    term
    Myocardial Infarction
time Frame
Adverse events were assessed for 3 years. All-Cause Mortality was assessed from date of randomization until death, assessed up to 5.2 years.

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Preserved source evidence · Not medical advice