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NCT06099782 · ADVERSE EVENTS

Adverse events

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11) · Source last updated 2026-04-08

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 15 months
Other-event reporting threshold
5%

All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab (+) Berahyaluronidase Alfa SC

In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.

20 / 14199 / 14110 / 141
Pembrolizumab IV

In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.

22 / 14163 / 1416 / 141

Group identifiers: EG000: Pembrolizumab (+) Berahyaluronidase Alfa SC · EG001: Pembrolizumab IV

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
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Acute myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Hypophysitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      141
      num Events
      2
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Duodenal ulcer haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Upper gastrointestinal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Death

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
      10
      num At Risk
      141
      num Events
      12
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      141
      num Events
      8
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      141
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      141
      num Events
      16
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      141
      num Events
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      141
      num Events
      8
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      141
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      141
      num Events
      9
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      141
      num Events
      12
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      141
      num Events
      8
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Injection site pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Injection site reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      141
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      141
      num Events
      5
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      141
      num Events
      15
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      141
      num Events
      16
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      141
      num Events
      12
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      141
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      141
      num Events
      9
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      141
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      141
      num Events
      8
    term
    Hyperglycaemia
Complete source fields
description
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
event Groups
  1. deaths Num Affected
    10
    deaths Num At Risk
    141
    description
    In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
    id
    EG000
    other Num Affected
    99
    other Num At Risk
    141
    serious Num Affected
    20
    serious Num At Risk
    141
    title
    Pembrolizumab (+) Berahyaluronidase Alfa SC
  2. deaths Num Affected
    6
    deaths Num At Risk
    141
    description
    In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
    id
    EG001
    other Num Affected
    63
    other Num At Risk
    141
    serious Num Affected
    22
    serious Num At Risk
    141
    title
    Pembrolizumab IV
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
      10
      num At Risk
      141
      num Events
      12
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      141
      num Events
      8
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      141
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      141
      num Events
      16
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      141
      num Events
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      141
      num Events
      8
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      141
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      141
      num Events
      9
    term
    Asthenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      141
      num Events
      12
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      141
      num Events
      8
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Injection site pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Injection site reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      141
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      141
      num Events
      5
    term
    Upper respiratory tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      141
      num Events
      15
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      141
      num Events
      16
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      141
      num Events
      12
    term
    Aspartate aminotransferase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      141
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      141
      num Events
      9
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      141
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      141
      num Events
      8
    term
    Hyperglycaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Acute myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Vertigo
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      141
      num Events
      0
    term
    Hypophysitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      141
      num Events
      2
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Duodenal ulcer haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Gastritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Upper gastrointestinal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      141
      num Events
      1
    term
    Death
time Frame
Up to approximately 15 months

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