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NCT01734928 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-06-06

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
AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment 1: POM + BTZ + LD-DEX

POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

177 / 278276 / 278197 / 281
Treatment 2: BTZ + LD-DEX

BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.

119 / 270260 / 270193 / 278

Group identifiers: EG000: Treatment 1: POM + BTZ + LD-DEX · EG001: Treatment 2: BTZ + LD-DEX

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
    20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      270
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      270
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      270
    term
    Hyperviscosity syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      270
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      270
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Angina unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      270
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      270
    term
    Atrial flutter

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
    20.0
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      270
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      270
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      270
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      270
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      110
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      270
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      270
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      270
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      270
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      270
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      270
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      270
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      270
    term
    Constipation
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
event Groups
  1. deaths Num Affected
    197
    deaths Num At Risk
    281
    description
    POM (Pomalidomide) * 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    EG000
    other Num Affected
    276
    other Num At Risk
    278
    serious Num Affected
    177
    serious Num At Risk
    278
    title
    Treatment 1: POM + BTZ + LD-DEX
  2. deaths Num Affected
    193
    deaths Num At Risk
    278
    description
    BTZ ((Bortezomib) * For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle * For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) * For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
    id
    EG001
    other Num Affected
    260
    other Num At Risk
    270
    serious Num Affected
    119
    serious Num At Risk
    270
    title
    Treatment 2: BTZ + LD-DEX
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      270
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      270
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      270
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      270
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      110
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      270
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      270
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      270
    term
    Cataract
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      270
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      270
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      270
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      270
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      106
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      270
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      270
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      270
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      270
    term
    Hyperviscosity syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      270
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      270
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      270
    term
    Angina unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      270
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      278
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      270
    term
    Atrial flutter
time Frame
AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.

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