Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02627963 · ADVERSE EVENTS

Adverse events

A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) · Source last updated 2023-07-18

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 first dose to last dose plus 30 days (up to approximately 5 years)
Other-event reporting threshold
5%

Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.

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

Participants randomized to this arm received the study drug, tivozanib hydrochloride.

81 / 173171 / 173114 / 175
Sorafenib

Participants randomized to this arm received the comparator drug, sorafenib.

67 / 170170 / 170113 / 175

Group identifiers: EG000: Tivozanib Hydrochloride · EG001: Sorafenib

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Pulmonary embolism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Pleural effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Acute respiratory failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Bronchial ulceration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Chronic obstructive pulmonary disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Haemoptysis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Laryngeal stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Epistaxis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Hydrothorax
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Pulmonary oedema

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      170
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      170
    term
    Stomatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      170
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      170
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      170
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      170
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      170
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      170
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      170
    term
    Dysphonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      170
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      170
    term
    Palmar-plantar erythrodysaesthesia syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      170
    term
    Rash
Complete source fields
description
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
event Groups
  1. deaths Num Affected
    114
    deaths Num At Risk
    175
    description
    Participants randomized to this arm received the study drug, tivozanib hydrochloride.
    id
    EG000
    other Num Affected
    171
    other Num At Risk
    173
    serious Num Affected
    81
    serious Num At Risk
    173
    title
    Tivozanib Hydrochloride
  2. deaths Num Affected
    113
    deaths Num At Risk
    175
    description
    Participants randomized to this arm received the comparator drug, sorafenib.
    id
    EG001
    other Num Affected
    170
    other Num At Risk
    170
    serious Num Affected
    67
    serious Num At Risk
    170
    title
    Sorafenib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      170
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      170
    term
    Stomatitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      170
    term
    Nausea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      170
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      170
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      170
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      170
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      170
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      170
    term
    Dysphonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      170
    term
    Decreased appetite
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      170
    term
    Palmar-plantar erythrodysaesthesia syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      170
    term
    Rash
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Pulmonary embolism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Pleural effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Dyspnoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Respiratory failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Acute respiratory failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Bronchial ulceration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Chronic obstructive pulmonary disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Haemoptysis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      170
    term
    Laryngeal stenosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Epistaxis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Hydrothorax
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      173
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      170
    term
    Pulmonary oedema
time Frame
From first dose to last dose plus 30 days (up to approximately 5 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice