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NCT02603887 · ADVERSE EVENTS

Adverse events

Pembrolizumab in Treating Patients With Intermediate or High-Risk Smoldering Multiple Myeloma · Source last updated 2026-07-17

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
From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months
Other-event reporting threshold
0%

All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Single Arm, Intermediate-high Risk SMM Participants

Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles

3 / 1313 / 131 / 13

Group identifiers: EG000: Single Arm, Intermediate-high Risk SMM Participants

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
    notes
    All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Transaminitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Myalgia

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    term
    Alanine aminotranferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Autoimmune disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Bronchial infection
Complete source fields
description
All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Pembrolizumab 200 mg, 30 minute IV infusion every 21 days up to 24 cycles if equal or higher than minor response and without serious adverse events after 8 cycles
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    3
    serious Num At Risk
    13
    title
    Single Arm, Intermediate-high Risk SMM Participants
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    term
    Acute kidney injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    term
    Alanine aminotranferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Alopecia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    term
    Aspartate aminotransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Autoimmune disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Bronchial infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    All adverse events were recorded on the adverse event case report/worksheet by the principal investigator and/or research team, as well as evaluated by a qualified physician
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Transaminitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    term
    Myalgia
time Frame
From time the consent form is signed through 90 days following cessation of treatment and at each examination on the Adverse Event case report/forms/worksheet, up to 2 years and 6 months

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Preserved source evidence · Not medical advice