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NCT02576977 · ADVERSE EVENTS

Adverse events

Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183) · Source last updated 2021-10-08

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
Up to approximately 54 months
Other-event reporting threshold
5%

The analysis population for all-cause mortality was all randomized participants and for adverse events was the treated participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment, therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs. The database cutoff date was August 3, 2020.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab+Pomalidomide+Dexamethasone

Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

79 / 122115 / 12286 / 126
Standard of Care (SOC) Pomalidomide+Dexamethasone

Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

57 / 123114 / 12364 / 125

Group identifiers: EG000: Pembrolizumab+Pomalidomide+Dexamethasone · EG001: Standard of Care (SOC) Pomalidomide+Dexamethasone

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      123
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Febrile bone marrow aplasia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      122
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      123
      num Events
      5
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Cardiogenic shock
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Myocarditis

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 21.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      122
      num Events
      53
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      123
      num Events
      57
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      122
      num Events
      21
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      123
      num Events
      16
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      122
      num Events
      120
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      123
      num Events
      63
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      122
      num Events
      49
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      123
      num Events
      27
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      122
      num Events
      37
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      123
      num Events
      27
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      122
      num Events
      30
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      123
      num Events
      35
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      122
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
      num Events
      7
    term
    Gastrooesophageal reflux disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      122
      num Events
      26
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      123
      num Events
      19
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      122
      num Events
      17
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      123
      num Events
      14
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      122
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      123
      num Events
      17
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      122
      num Events
      11
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      123
      num Events
      6
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      122
      num Events
      36
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      123
      num Events
      44
    term
    Fatigue
Complete source fields
description
The analysis population for all-cause mortality was all randomized participants and for adverse events was the treated participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment, therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs. The database cutoff date was August 3, 2020.
event Groups
  1. deaths Num Affected
    86
    deaths Num At Risk
    126
    description
    Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    EG000
    other Num Affected
    115
    other Num At Risk
    122
    serious Num Affected
    79
    serious Num At Risk
    122
    title
    Pembrolizumab+Pomalidomide+Dexamethasone
  2. deaths Num Affected
    64
    deaths Num At Risk
    125
    description
    Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    EG001
    other Num Affected
    114
    other Num At Risk
    123
    serious Num Affected
    57
    serious Num At Risk
    123
    title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      122
      num Events
      53
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      123
      num Events
      57
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      122
      num Events
      21
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      123
      num Events
      16
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      122
      num Events
      120
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      123
      num Events
      63
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      122
      num Events
      49
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      123
      num Events
      27
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      122
      num Events
      37
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      123
      num Events
      27
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      122
      num Events
      30
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      123
      num Events
      35
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      122
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      123
      num Events
      7
    term
    Gastrooesophageal reflux disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      122
      num Events
      26
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      123
      num Events
      19
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      122
      num Events
      17
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      123
      num Events
      14
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      122
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      123
      num Events
      17
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      122
      num Events
      11
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      123
      num Events
      6
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      122
      num Events
      36
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      123
      num Events
      44
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      123
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Febrile bone marrow aplasia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      122
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      123
      num Events
      5
    term
    Febrile neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      122
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      123
      num Events
      1
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Cardiogenic shock
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      122
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      123
      num Events
      0
    term
    Myocarditis
time Frame
Up to approximately 54 months

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