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NCT02535247 · ADVERSE EVENTS

Adverse events

Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma · Source last updated 2022-07-08

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
2 years
Other-event reporting threshold
0%

Study did not progress to portion with combination of pembrolizumab and copanlisib.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment

MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475

12 / 1717 / 1711 / 17
Combination

MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib

0 / 00 / 00 / 0

Group identifiers: EG000: Treatment · EG001: Combination

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Intractable vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Methicillin-Resistant Staphyloccus aureus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lung infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Renal Insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Bilateral pneumonia

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Edema limbs
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    General disorders and administration site conditions - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Injection site reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Flu like symptoms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Localized edema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Mucositis
Complete source fields
description
Study did not progress to portion with combination of pembrolizumab and copanlisib.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    17
    description
    MK-3475 given intravenously at a fixed dose of 200mg every 3 weeks for up to 36 cycles MK-3475
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    12
    serious Num At Risk
    17
    title
    Treatment
  2. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    MK-3475 is given intravenously at a fixed dose of 200mg every 3 weeks Copanlisib is given intravenously at RP2D determined from Phase I study MK-3475 Copanlisib
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Combination
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Fever
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Edema limbs
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    General disorders and administration site conditions - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Injection site reaction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Flu like symptoms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Localized edema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Mucositis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Ascites
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Intractable vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Hypotension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Methicillin-Resistant Staphyloccus aureus infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Lung infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Sepsis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Renal Insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
    term
    Bilateral pneumonia
time Frame
2 years

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Preserved source evidence · Not medical advice