Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03749460 · ADVERSE EVENTS

Adverse events

Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers · Source last updated 2023-12-29

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
Up to 4 years
Other-event reporting threshold
0%

Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Nivolumab, Ipilimumab, SBRT)

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT

3 / 2020 / 209 / 20

Group identifiers: EG000: Treatment (Nivolumab, Ipilimumab, SBRT)

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
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Right Rib Fracture
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Right Coracoid Fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Adrenal Insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Oral Bleeding
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pneumonia
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Lung Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hypotension

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      7
    term
    Abdominal Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Adrenal Insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Allergic Reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Arthritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Aspirational Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Back Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bilateral Upper Extremity Edema
Complete source fields
description
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    20
    description
    Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    3
    serious Num At Risk
    20
    title
    Treatment (Nivolumab, Ipilimumab, SBRT)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      20
      num Events
      7
    term
    Abdominal Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
      num Events
      3
    term
    Adrenal Insufficiency
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Allergic Reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
      num Events
      6
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Anxiety
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Arthralgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Arthritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Aspirational Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Back Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Bilateral Upper Extremity Edema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Right Rib Fracture
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Right Coracoid Fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Adrenal Insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Oral Bleeding
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pneumonia
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Lung Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hypotension
time Frame
Up to 4 years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice