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NCT03698019 · ADVERSE EVENTS

Adverse events

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma · Source last updated 2026-08-04

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
Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization
Other-event reporting threshold
5%

AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Adjuvant Pembrolizumab)

Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery

33 / 141132 / 14122 / 159
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery

34 / 152148 / 15214 / 154

Group identifiers: EG000: Arm I (Adjuvant Pembrolizumab) · EG001: Arm II (Adjuvant and Neoadjuvant Pembrolizumab)

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Cardiac disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
    term
    Myocarditis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Endocrine disorders-Other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      152
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      152
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Pancreatitis

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
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      152
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      152
    term
    Blood and lymphatic system disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      152
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      152
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      152
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      152
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      152
    term
    Eye disorders-Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      152
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      152
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      152
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      152
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      152
    term
    Gastrointestinal disorders-Other
Complete source fields
description
AEs and SAEs are reported by CTCAE v5.0. 152 participants on the neoadjuvant arm and 141 participants on the adjuvant arm that were eligible and received some protocol treatment were evaluable for AEs. 154 eligible participants on the neoadjuvant arm and 159 eligible participants on the adjuvant arm were analyzed for all-cause mortality.
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    159
    description
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    EG000
    other Num Affected
    132
    other Num At Risk
    141
    serious Num Affected
    33
    serious Num At Risk
    141
    title
    Arm I (Adjuvant Pembrolizumab)
  2. deaths Num Affected
    14
    deaths Num At Risk
    154
    description
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    EG001
    other Num Affected
    148
    other Num At Risk
    152
    serious Num Affected
    34
    serious Num At Risk
    152
    title
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      152
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      152
    term
    Blood and lymphatic system disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      152
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      152
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      152
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      152
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      152
    term
    Eye disorders-Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      152
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      152
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      152
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      152
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      152
    term
    Gastrointestinal disorders-Other
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Cardiac disorders-Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Chest pain - cardiac
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
    term
    Myocarditis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      152
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Endocrine disorders-Other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      152
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      152
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      152
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      152
    term
    Pancreatitis
time Frame
Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization

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