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NCT02289222 · ADVERSE EVENTS

Adverse events

1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-05

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
Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pomalidomide, Dexamethasone & MK-3475

Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14). MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks. Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days Dexamethasone: Dexamethasone is given at 40 mg orally weekly

27 / 4848 / 482 / 48

Group identifiers: EG000: Pomalidomide, Dexamethasone & MK-3475

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
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    heart failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    lower gastrointestinal hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    term
    fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    fracture
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    hip fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    other, bacteremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    alanine aminotransferase increased

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
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      48
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      48
    term
    lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      48
    term
    neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      48
    term
    platelet count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      48
    term
    white blood cell decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
    term
    atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      48
    term
    palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
    term
    sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
    term
    ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
    term
    hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      48
    term
    blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      48
    term
    abdominal pain
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    48
    description
    Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14). MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks. Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days Dexamethasone: Dexamethasone is given at 40 mg orally weekly
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    48
    serious Num Affected
    27
    serious Num At Risk
    48
    title
    Pomalidomide, Dexamethasone & MK-3475
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      48
    term
    anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      48
    term
    lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      48
    term
    neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      48
    term
    platelet count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      48
    term
    white blood cell decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
    term
    atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      48
    term
    palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
    term
    sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
    term
    ear pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      48
    term
    hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      48
    term
    blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      48
    term
    abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    acute coronary syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    heart failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    colitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    lower gastrointestinal hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
    term
    fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    fracture
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    hip fracture
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    other, bacteremia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE 4.03
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
    term
    alanine aminotransferase increased
time Frame
Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.

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