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NCT00387335 · ADVERSE EVENTS

Adverse events

Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer · Source last updated 2014-07-25

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 two years
Other-event reporting threshold
5%

Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sunitinib -- Cohort A

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.

3 / 1514 / 15Not reported / Not reported
Sunitinib -- Cohort B

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.

1 / 77 / 7Not reported / Not reported

Group identifiers: EG000: Sunitinib -- Cohort A · EG001: Sunitinib -- Cohort B

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Sudden death from sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Sudden cardiac death
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 2
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Pulmonary hemorrhage
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Neutrophil count decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Leukocytes
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Platelet count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Anorexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Mucositis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Hypertension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hyponatremia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Headache
Complete source fields
description
Common Terminology Criteria for Adverse Events (CTCAE v3.0). Reported are grade 1 or higher adverse events.
event Groups
  1. description
    Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    15
    serious Num Affected
    3
    serious Num At Risk
    15
    title
    Sunitinib -- Cohort A
  2. description
    Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Sunitinib -- Cohort B
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Neutrophil count decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Leukocytes
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Platelet count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Fatigue
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Anorexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Mucositis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    term
    Hypertension
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Hyponatremia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Headache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Sudden death from sepsis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    term
    Sudden cardiac death
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 2
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Pulmonary hemorrhage
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
time Frame
Up to two years

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

Preserved source evidence · Not medical advice