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NCT01064310 · ADVERSE EVENTS

Adverse events

Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer · Source last updated 2017-04-17

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
Sunitinib

Sunitinib

35 / 148143 / 148Not reported / Not reported
Pazopanib

Pazopanib

30 / 153142 / 153Not reported / Not reported
Open Label Pazopanib

Open Label Pazopanib

15 / 8473 / 84Not reported / Not reported

Group identifiers: EG000: Sunitinib · EG001: Pazopanib · EG002: Open Label Pazopanib

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 V19.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Myocardial ischaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Anal fissure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Anal fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Diarrhoea

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 V19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      84
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      84
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      84
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      84
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Flatulence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      84
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Stomatitis
Complete source fields
event Groups
  1. description
    Sunitinib
    id
    EG000
    other Num Affected
    143
    other Num At Risk
    148
    serious Num Affected
    35
    serious Num At Risk
    148
    title
    Sunitinib
  2. description
    Pazopanib
    id
    EG001
    other Num Affected
    142
    other Num At Risk
    153
    serious Num Affected
    30
    serious Num At Risk
    153
    title
    Pazopanib
  3. description
    Open Label Pazopanib
    id
    EG002
    other Num Affected
    73
    other Num At Risk
    84
    serious Num Affected
    15
    serious Num At Risk
    84
    title
    Open Label Pazopanib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      84
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      84
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      84
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      84
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      84
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      84
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Flatulence
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      84
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      84
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      84
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Atrial flutter
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Myocardial ischaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Anal fissure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      84
    term
    Anal fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA V19.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      148
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      153
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      84
    term
    Diarrhoea

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