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NCT02036502 · ADVERSE EVENTS

Adverse events

A Study of Pembrolizumab (MK-3475) in Combination With Standard of Care Treatments in Participants With Multiple Myeloma (MK-3475-023/KEYNOTE-023) · Source last updated 2021-04-08

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 72.7 months
Other-event reporting threshold
5%

The analysis population for adverse events (AEs) consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to study treatment are excluded. All-cause mortality is reported for all randomized participants.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg

Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).

2 / 66 / 63 / 6
Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg

Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).

3 / 33 / 33 / 4
Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg

Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).

2 / 66 / 61 / 6
Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg

Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).

1 / 11 / 10 / 2
Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg

Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).

1 / 11 / 10 / 1
Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg

Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.

19 / 4544 / 4531 / 47
Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg

Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.

0 / 11 / 10 / 1
Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg

Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.

9 / 1010 / 106 / 10

Group identifiers: EG000: Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg · EG001: Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg · EG002: Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg · EG003: Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg · EG004: Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg · EG005: Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg · EG006: Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg · EG007: Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg

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
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anaemia
  2. 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
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      45
      num Events
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Febrile neutropenia
  3. 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
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      45
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Pancytopenia
  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
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac amyloidosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypopituitarism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Colitis ischaemic
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Multiple organ dysfunction syndrome

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
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      45
      num Events
      32
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      10
      num Events
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      45
      num Events
      45
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      45
      num Events
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      10
      num Events
      5
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      45
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cardiac amyloidosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      45
      num Events
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Blindness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      45
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Eyelid oedema
Complete source fields
description
The analysis population for adverse events (AEs) consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to study treatment are excluded. All-cause mortality is reported for all randomized participants.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg once every 2 weeks (Q2W) (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg once weekly (Q1W) during Cycle 1 (28-day cycle).
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Part 1:Pembro 2mg/kg+Len 25mg+Dex 40 mg
  2. deaths Num Affected
    3
    deaths Num At Risk
    4
    description
    Participants in Part 1 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 2 mg/kg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Part 1:Pembro 2mg/kg+Len 10 mg+Dex 40 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Part 2:Pembro 200 mg+Len 25 mg+Dex 40 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during Cycle 1 (28-day cycle).
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Part 2:Pembro 200 mg+Len 25 mg+Dex 20 mg
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants in Part 2 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 10 mg (Days 1-21) and dexamethasone 40 mg Q1W during Cycle 1 (28-day cycle).
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Part 2:Pembro 200 mg+Len 10 mg+Dex 40 mg
  6. deaths Num Affected
    31
    deaths Num At Risk
    47
    description
    Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 40 mg Q1W during each 28-day cycle.
    id
    EG005
    other Num Affected
    44
    other Num At Risk
    45
    serious Num Affected
    19
    serious Num At Risk
    45
    title
    Part 3:Pembro 200 mg+Len 25 mg+Dex 40 mg
  7. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants in Part 3 with refractory or relapsed and refractory multiple myeloma (rrMM) received pembrolizumab 200 mg Q2W (Days 1 and 15) in combination with lenalidomide 25 mg (Days 1-21) and dexamethasone 20 mg Q1W during each 28-day cycle.
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Part 3:Pembro 200 mg+Len 25 mg+Dex 20 mg
  8. deaths Num Affected
    6
    deaths Num At Risk
    10
    description
    Participants in Part 3 with relapsed or refractory multiple myeloma (rMM) received pembrolizumab 200 mg Q3W in combination with carfilzomib 56 mg/m\^2 (Days 1, 2, 8, 9, 15, 16) and dexamethasone 20 mg (Days 1, 2, 8, 9, 15, 16, 22, 23) during each 28-day cycle.
    id
    EG007
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    9
    serious Num At Risk
    10
    title
    Part 3:Pembro 200 mg+Carf 56 mg/m^2 +Dex 20 mg
frequency Threshold
5
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
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      45
      num Events
      32
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      10
      num Events
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      18
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      45
      num Events
      45
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      10
      num Events
      3
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      36
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      18
      num At Risk
      45
      num Events
      38
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      10
      num Events
      5
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      45
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cardiac amyloidosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      45
      num Events
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Blindness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      45
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Eyelid oedema
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
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anaemia
  2. 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
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      45
      num Events
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Febrile neutropenia
  3. 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
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      45
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Pancytopenia
  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
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac amyloidosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypopituitarism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      45
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Colitis ischaemic
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Death
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      45
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Multiple organ dysfunction syndrome
time Frame
Up to approximately 72.7 months

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Preserved source evidence · Not medical advice