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NCT04704219 · ADVERSE EVENTS

Adverse events

Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) · Source last updated 2025-12-03

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 56 months
Other-event reporting threshold
5%

All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.

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

Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.

76 / 158155 / 15879 / 160
Pembrolizumab + Lenvatinib Second Course

Participants who experienced progression of Renal Cell Carcinoma (RCC) by radiographic evaluation continued second course treatment of 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 1 year PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.

2 / 64 / 60 / 6

Group identifiers: EG000: Pembrolizumab + Lenvatinib · EG001: Pembrolizumab + Lenvatinib Second Course

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      158
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      158
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      158
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Coronary artery stenosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Heart failure with reduced ejection fraction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Myocardial infarction

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      158
      num Events
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      158
      num Events
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      158
      num Events
      102
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      158
      num Events
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      158
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      158
      num Events
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      158
      num Events
      238
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      158
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      158
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      158
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      158
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      158
      num Events
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Nausea
Complete source fields
description
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all allocated participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were excluded.
event Groups
  1. deaths Num Affected
    79
    deaths Num At Risk
    160
    description
    Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
    id
    EG000
    other Num Affected
    155
    other Num At Risk
    158
    serious Num Affected
    76
    serious Num At Risk
    158
    title
    Pembrolizumab + Lenvatinib
  2. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Participants who experienced progression of Renal Cell Carcinoma (RCC) by radiographic evaluation continued second course treatment of 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 1 year PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Pembrolizumab + Lenvatinib Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      158
      num Events
      25
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      158
      num Events
      27
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      158
      num Events
      102
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      158
      num Events
      33
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      158
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      158
      num Events
      39
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      158
      num Events
      238
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      158
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      158
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      158
      num Events
      17
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      158
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      158
      num Events
      79
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      158
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      158
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      158
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Coronary artery stenosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Heart failure with reduced ejection fraction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      158
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Myocardial infarction
time Frame
Up to approximately 56 months

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