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NCT00095628 · ADVERSE EVENTS

Adverse events

SB-715992 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2017-03-06

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Ispinesib)

Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies

6 / 2020 / 20Not reported / Not reported

Group identifiers: EG000: Treatment (Ispinesib)

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Anorexia
  2. 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
    Cough
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Dyspnea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    White blood count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neutrophil count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hyperkalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Tracheal hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Edema face
  10. 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
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Upper respiratory infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Injury to superior vena cava

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
    notes
    Neutrophil count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      20
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    White blood count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      20
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Lymphocyte count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    term
    Hyponatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Hypoalbuminemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Injection site reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Bone pain
Complete source fields
event Groups
  1. description
    Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ispinesib: Given IV laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    6
    serious Num At Risk
    20
    title
    Treatment (Ispinesib)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neutrophil count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      20
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    White blood count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      20
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Lymphocyte count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      20
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      20
    term
    Hyponatremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      20
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Hypoalbuminemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Injection site reaction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      20
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
    term
    Bone pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Anorexia
  2. 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
    Cough
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      20
      num Events
      2
    term
    Dyspnea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    White blood count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Neutrophil count decreased
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Hyperkalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Pneumonia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Tracheal hemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Edema face
  10. 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
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Upper respiratory infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      20
      num Events
      1
    term
    Injury to superior vena cava

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Preserved source evidence · Not medical advice