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NCT03172624 · ADVERSE EVENTS

Adverse events

Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer · Source last updated 2025-12-18

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
R/M Adenoid Cystic Carcinoma (ACC)

Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks). Nivolumab: nivolumab 3 mg/kg every 2 weeks Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)

18 / 3211 / 326 / 32
R/M SGC of Any Histology, Except ACC (Non ACC)

Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks). Nivolumab: nivolumab 3 mg/kg every 2 weeks Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)

9 / 3214 / 327 / 32

Group identifiers: EG000: R/M Adenoid Cystic Carcinoma (ACC) · EG001: R/M SGC of Any Histology, Except ACC (Non ACC)

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Bone marrow hypocellular
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Bronchopulmonary hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Cardiac disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Confusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Death NOS

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      32
    term
    Hyponatremia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Hypophosphatemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      32
    term
    Lymphocyte count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    term
    White blood cell decreased
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    32
    description
    Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks). Nivolumab: nivolumab 3 mg/kg every 2 weeks Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    32
    serious Num Affected
    18
    serious Num At Risk
    32
    title
    R/M Adenoid Cystic Carcinoma (ACC)
  2. deaths Num Affected
    7
    deaths Num At Risk
    32
    description
    Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks). Nivolumab: nivolumab 3 mg/kg every 2 weeks Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
    id
    EG001
    other Num Affected
    14
    other Num At Risk
    32
    serious Num Affected
    9
    serious Num At Risk
    32
    title
    R/M SGC of Any Histology, Except ACC (Non ACC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      32
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      32
    term
    Hyponatremia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      32
    term
    Hypophosphatemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      32
    term
    Lymphocyte count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    term
    Neutrophil count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      32
    term
    White blood cell decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Bone marrow hypocellular
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      32
    term
    Bronchopulmonary hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Cardiac disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Confusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      32
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      32
    term
    Death NOS
time Frame
2 years

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