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NCT03690388 · ADVERSE EVENTS

Adverse events

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy · Source last updated 2025-09-25

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
1 year, 8 months.
Other-event reporting threshold
5%

Safety assessments included evaluations of AEs, SAEs, deaths, clinical laboratory test results (hematology, serum chemistry, and urinalysis), physical examination findings, vital sign measurements, Eastern Cooperative Oncology Group performance status (ECOG PS), and 12-lead ECG recordings.

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

cabozantinib (60 mg) once daily orally (qd) Cabozantinib: Tablets containing 60-mg or 20-mg cabozantinib once daily orally.

43 / 125112 / 12517 / 125
Placebo

placebo once daily orally (qd) Placebo: Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.

18 / 6232 / 6214 / 62

Group identifiers: EG000: 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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      62
    term
    Pleural effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Pulmonary embolism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      62
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Haemoptysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Laryngeal necrosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Lung disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Pneumonitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Pneumothorax
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Hydrothorax
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Ascites

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
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      62
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      62
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      62
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      62
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      62
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Palmar-plantar erythrodysaesthesia syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      62
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      62
    term
    Asthenia
Complete source fields
description
Safety assessments included evaluations of AEs, SAEs, deaths, clinical laboratory test results (hematology, serum chemistry, and urinalysis), physical examination findings, vital sign measurements, Eastern Cooperative Oncology Group performance status (ECOG PS), and 12-lead ECG recordings.
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    125
    description
    cabozantinib (60 mg) once daily orally (qd) Cabozantinib: Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
    id
    EG000
    other Num Affected
    112
    other Num At Risk
    125
    serious Num Affected
    43
    serious Num At Risk
    125
    title
    Cabozantinib
  2. deaths Num Affected
    14
    deaths Num At Risk
    62
    description
    placebo once daily orally (qd) Placebo: Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
    id
    EG001
    other Num Affected
    32
    other Num At Risk
    62
    serious Num Affected
    18
    serious Num At Risk
    62
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      62
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      62
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      62
    term
    Stomatitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      62
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      62
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Palmar-plantar erythrodysaesthesia syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Alopecia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      62
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      62
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      62
    term
    Pleural effusion
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Pulmonary embolism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      62
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Haemoptysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Laryngeal necrosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Lung disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Pneumonitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Pneumothorax
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      62
    term
    Hydrothorax
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      62
    term
    Ascites
time Frame
1 year, 8 months.

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