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NCT01876511 · ADVERSE EVENTS

Adverse events

Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C) · Source last updated 2020-02-06

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
2 years 4 months Study treatment was administered for up to 2 years. Adverse events were accessed through 90 days after the last dose of study treatment.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A: MSI Positive Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

4 / 4141 / 413 / 41
Cohort B: MSI Negative Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

0 / 253 / 250 / 25
Cohort C: MSI Positive Non-Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

7 / 4747 / 472 / 47

Group identifiers: EG000: Cohort A: MSI Positive Colorectal Cancer · EG001: Cohort B: MSI Negative Colorectal Cancer · EG002: Cohort C: MSI Positive Non-Colorectal Cancer

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Arthritis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Pancreatitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Myocarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Diabetic ketoacidosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Infusion reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Neuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Cellulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Alanine aminotransferase Increased (ALT)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Aspartate aminotransferase increased (AST)

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
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      41
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      47
      num Events
      13
    term
    Hypothyroidism/thyroiditis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      41
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      47
      num Events
      9
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      47
      num Events
      8
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    and administration site conditions
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      41
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      47
      num Events
      13
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    term
    Alanine aminotransferase Increased (ALT)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      47
      num Events
      5
    term
    Aspartate aminotransferase increased (AST)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      47
      num Events
      5
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      41
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      47
      num Events
      5
    term
    Neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      41
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      47
      num Events
      13
    term
    Pruritus
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    41
    description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    4
    serious Num At Risk
    41
    title
    Cohort A: MSI Positive Colorectal Cancer
  2. deaths Num Affected
    0
    deaths Num At Risk
    25
    description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    25
    serious Num Affected
    0
    serious Num At Risk
    25
    title
    Cohort B: MSI Negative Colorectal Cancer
  3. deaths Num Affected
    2
    deaths Num At Risk
    47
    description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    EG002
    other Num Affected
    47
    other Num At Risk
    47
    serious Num Affected
    7
    serious Num At Risk
    47
    title
    Cohort C: MSI Positive Non-Colorectal Cancer
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      41
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      47
      num Events
      13
    term
    Hypothyroidism/thyroiditis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      41
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      47
      num Events
      9
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      47
      num Events
      8
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    and administration site conditions
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      41
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      47
      num Events
      13
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    term
    Alanine aminotransferase Increased (ALT)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      47
      num Events
      5
    term
    Aspartate aminotransferase increased (AST)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      47
      num Events
      5
    term
    Lymphocyte count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      47
      num Events
      3
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      41
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      47
      num Events
      4
    term
    Arthralgia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      47
      num Events
      5
    term
    Neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      41
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      47
      num Events
      13
    term
    Pruritus
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Arthritis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Pancreatitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Myocarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Diabetic ketoacidosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Infusion reaction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Neuropathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      47
      num Events
      0
    term
    Cellulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Alanine aminotransferase Increased (ALT)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      41
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Aspartate aminotransferase increased (AST)
time Frame
2 years 4 months Study treatment was administered for up to 2 years. Adverse events were accessed through 90 days after the last dose of study treatment.

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Preserved source evidence · Independent clinical review pending · Not medical advice