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NCT02576990 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170) · Source last updated 2023-07-27

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
Serious adverse events (AEs), non-serious AEs and all-cause mortality was collected up to approximately 56 months through end of trial (EOT) data cut-off date 23 Oct 2020.
Other-event reporting threshold
5%

All-cause mortality was reported on all allocated participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug were excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).

14 / 5346 / 5330 / 56
Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)

Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).

15 / 2323 / 2319 / 24

Group identifiers: EG000: Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) · EG001: Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Autoimmune haemolytic anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      4
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Cardiac tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hypercalcaemia of malignancy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hyperthyroidism

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      23
      num Events
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Lymph node pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
      num Events
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      23
      num Events
      5
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      23
      num Events
      7
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Vomiting
Complete source fields
description
All-cause mortality was reported on all allocated participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug were excluded.
event Groups
  1. deaths Num Affected
    30
    deaths Num At Risk
    56
    description
    Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
    id
    EG000
    other Num Affected
    46
    other Num At Risk
    53
    serious Num Affected
    14
    serious Num At Risk
    53
    title
    Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
  2. deaths Num Affected
    19
    deaths Num At Risk
    24
    description
    Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
    id
    EG001
    other Num Affected
    23
    other Num At Risk
    23
    serious Num Affected
    15
    serious Num At Risk
    23
    title
    Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      23
      num Events
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Lymph node pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
      num Events
      29
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      9
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      23
      num Events
      5
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      23
      num Events
      7
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Autoimmune haemolytic anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      23
      num Events
      4
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Cardiac tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Pericarditis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hypercalcaemia of malignancy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Hyperthyroidism
time Frame
Serious adverse events (AEs), non-serious AEs and all-cause mortality was collected up to approximately 56 months through end of trial (EOT) data cut-off date 23 Oct 2020.

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