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NCT01835158 · ADVERSE EVENTS

Adverse events

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer · Source last updated 2021-02-11

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Cabozantinib-s-malate)

Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

39 / 7876 / 78Not reported / Not reported
Arm II (Sunitinib Malate)

Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

39 / 7268 / 72Not reported / Not reported

Group identifiers: EG000: Arm I (Cabozantinib-s-malate) · EG001: Arm II (Sunitinib Malate)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Colonic perforation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      6
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Esophageal pain

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      78
      num Events
      94
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      72
      num Events
      103
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      3
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Ear and labyrinth disorders - Oth spec
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Hearing impaired
Complete source fields
event Groups
  1. description
    Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    76
    other Num At Risk
    78
    serious Num Affected
    39
    serious Num At Risk
    78
    title
    Arm I (Cabozantinib-s-malate)
  2. description
    Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    68
    other Num At Risk
    72
    serious Num Affected
    39
    serious Num At Risk
    72
    title
    Arm II (Sunitinib Malate)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      78
      num Events
      94
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      72
      num Events
      103
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Heart failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      3
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Ear and labyrinth disorders - Oth spec
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Ear pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Hearing impaired
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Colonic perforation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      78
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      72
      num Events
      6
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Esophageal pain

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