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NCT02579863 · ADVERSE EVENTS

Adverse events

Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185) · Source last updated 2021-07-20

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 55 months
Other-event reporting threshold
5%

The All-Cause Mortality analysis used all randomized participants whereas adverse events were collected for all treated participants. Disease progression of cancer under study was not considered an adverse event (AE) unless related to study treatment. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms Neoplasm progression, Malignant neoplasm progression and Disease progression not related to study treatment were excluded as AEs. The Database Cutoff Date was Aug. 3, 2020.

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

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

91 / 154143 / 15451 / 156
Lenolidomide + Dexamethasone

Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

65 / 148129 / 14843 / 154

Group identifiers: EG000: Pembrolizumab + Lenalidomide + Dexamethasone · EG001: Lenolidomide + 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 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      154
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      148
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Cytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      154
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      148
      num Events
      3
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      154
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      2
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      2
    term
    Cardiac failure

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      154
      num Events
      48
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      148
      num Events
      40
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      154
      num Events
      54
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      148
      num Events
      51
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      154
      num Events
      16
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      148
      num Events
      19
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      154
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      154
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      148
      num Events
      3
    term
    Vision blurred
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      154
      num Events
      16
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      148
      num Events
      18
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      154
      num Events
      62
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      148
      num Events
      35
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      154
      num Events
      51
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      148
      num Events
      48
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      154
      num Events
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      148
      num Events
      5
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      154
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      2
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      154
      num Events
      54
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      148
      num Events
      38
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      154
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      148
      num Events
      6
    term
    Stomatitis
Complete source fields
description
The All-Cause Mortality analysis used all randomized participants whereas adverse events were collected for all treated participants. Disease progression of cancer under study was not considered an adverse event (AE) unless related to study treatment. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms Neoplasm progression, Malignant neoplasm progression and Disease progression not related to study treatment were excluded as AEs. The Database Cutoff Date was Aug. 3, 2020.
event Groups
  1. deaths Num Affected
    51
    deaths Num At Risk
    156
    description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    EG000
    other Num Affected
    143
    other Num At Risk
    154
    serious Num Affected
    91
    serious Num At Risk
    154
    title
    Pembrolizumab + Lenalidomide + Dexamethasone
  2. deaths Num Affected
    43
    deaths Num At Risk
    154
    description
    Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    EG001
    other Num Affected
    129
    other Num At Risk
    148
    serious Num Affected
    65
    serious Num At Risk
    148
    title
    Lenolidomide + Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      154
      num Events
      48
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      148
      num Events
      40
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      154
      num Events
      54
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      148
      num Events
      51
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      154
      num Events
      16
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      148
      num Events
      19
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      154
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      154
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      148
      num Events
      3
    term
    Vision blurred
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      154
      num Events
      16
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      148
      num Events
      18
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      154
      num Events
      62
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      148
      num Events
      35
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      154
      num Events
      51
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      148
      num Events
      48
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      154
      num Events
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      148
      num Events
      5
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      154
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      2
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      154
      num Events
      54
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      148
      num Events
      38
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      154
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      148
      num Events
      6
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      154
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      148
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Cytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      154
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      148
      num Events
      3
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      154
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      148
      num Events
      1
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      154
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      2
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      154
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      148
      num Events
      0
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      154
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      148
      num Events
      2
    term
    Cardiac failure
time Frame
Up to approximately 55 months

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