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NCT00704730 · ADVERSE EVENTS

Adverse events

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer · Source last updated 2021-04-20

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
From baseline at regular intervals through to the date of the primary analysis
Other-event reporting threshold
5%

The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
XL184 (Cabozantinib)

XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily

90 / 214213 / 214Not reported / Not reported
Placebo

oral capsules once daily

25 / 109102 / 109Not reported / Not reported

Group identifiers: EG000: XL184 (Cabozantinib) · EG001: Placebo

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 (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Haemolytic uraemic syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      214
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Cardiopulmonary failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Hypoacusis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Ectopic acth syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      214
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Abdominal 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 (14.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      214
      num Events
      14
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      109
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      214
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      214
      num Events
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      214
      num Events
      34
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      109
      num Events
      7
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      214
      num Events
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      109
      num Events
      6
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      214
      num Events
      57
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      109
      num Events
      6
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      214
      num Events
      135
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      109
      num Events
      36
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      214
      num Events
      28
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      109
      num Events
      9
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      214
      num Events
      24
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      214
      num Events
      25
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      109
      num Events
      7
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      214
      num Events
      15
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      109
      num Events
      4
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      214
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Glossodynia
Complete source fields
description
The safety data includes subjects who were randomized and treated. Of 330 subjects, 219 were randomized to receive XL184, 111 placebo. Seven subjects were randomized and not treated; there were 214 subjects treated with XL184 and 109 subjects who received placebo.
event Groups
  1. description
    XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
    id
    EG000
    other Num Affected
    213
    other Num At Risk
    214
    serious Num Affected
    90
    serious Num At Risk
    214
    title
    XL184 (Cabozantinib)
  2. description
    oral capsules once daily
    id
    EG001
    other Num Affected
    102
    other Num At Risk
    109
    serious Num Affected
    25
    serious Num At Risk
    109
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      214
      num Events
      14
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      109
      num Events
      10
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      214
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      214
      num Events
      20
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      214
      num Events
      34
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      109
      num Events
      7
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      214
      num Events
      16
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      109
      num Events
      6
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      214
      num Events
      57
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      109
      num Events
      6
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      214
      num Events
      135
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      109
      num Events
      36
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      214
      num Events
      28
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      109
      num Events
      9
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      214
      num Events
      24
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      214
      num Events
      25
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      109
      num Events
      7
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      214
      num Events
      15
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      109
      num Events
      4
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      214
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Glossodynia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Haemolytic uraemic syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      214
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Cardiopulmonary failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Left ventricular dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Supraventricular tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Hypoacusis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Ectopic acth syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (14.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      214
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Abdominal pain
time Frame
From baseline at regular intervals through to the date of the primary analysis

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