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NCT00410761 · ADVERSE EVENTS

Adverse events

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer · Source last updated 2025-09-24

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
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.
Other-event reporting threshold
5%

The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Randomized Treatment Period: Vandetanib 300 mg

Participants received vandetanib 300 mg orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period.

92 / 231226 / 23166 / 231
Randomized Treatment Period: Placebo

Participants received placebo matched to vandetanib orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period.

16 / 9987 / 9910 / 100
Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg

Participants who received vandetanib 300 mg during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to continue to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.

53 / 10932 / 10952 / 109
Open-Label Treatment Period: Placebo/Vandetanib 300 mg

Participants who received placebo matched to vandetanib during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.

36 / 7970 / 7941 / 79

Group identifiers: EG000: Randomized Treatment Period: Vandetanib 300 mg · EG001: Randomized Treatment Period: Placebo · EG002: Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg · EG003: Open-Label Treatment Period: Placebo/Vandetanib 300 mg

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 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Disseminated Intravascular Coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Acute Myocardial Infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Atrial Fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardiac Failure Acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardiac Failure Congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardio-Respiratory Arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardiovascular Insufficiency

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      231
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      5
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      231
      num Events
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      231
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Corneal Opacity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      231
      num Events
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      5
    term
    Vision Blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      231
      num Events
      50
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      6
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      231
      num Events
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      5
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      231
      num Events
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      109
      num Events
      3
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      79
      num Events
      9
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      231
      num Events
      180
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      99
      num Events
      36
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      79
      num Events
      39
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      231
      num Events
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      79
      num Events
      7
    term
    Dry Mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      231
      num Events
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      231
      num Events
      97
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      99
      num Events
      16
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      79
      num Events
      24
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      231
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Toothache
Complete source fields
description
The safety population included all participants who received at least 1 dose of vandetanib/placebo. All-cause mortality (deaths) was assessed in all randomized participants.
event Groups
  1. deaths Num Affected
    66
    deaths Num At Risk
    231
    description
    Participants received vandetanib 300 mg orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period.
    id
    EG000
    other Num Affected
    226
    other Num At Risk
    231
    serious Num Affected
    92
    serious Num At Risk
    231
    title
    Randomized Treatment Period: Vandetanib 300 mg
  2. deaths Num Affected
    10
    deaths Num At Risk
    100
    description
    Participants received placebo matched to vandetanib orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period.
    id
    EG001
    other Num Affected
    87
    other Num At Risk
    99
    serious Num Affected
    16
    serious Num At Risk
    99
    title
    Randomized Treatment Period: Placebo
  3. deaths Num Affected
    52
    deaths Num At Risk
    109
    description
    Participants who received vandetanib 300 mg during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to continue to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.
    id
    EG002
    other Num Affected
    32
    other Num At Risk
    109
    serious Num Affected
    53
    serious Num At Risk
    109
    title
    Open-Label Treatment Period: Vandetanib 300 mg/Vandetanib 300 mg
  4. deaths Num Affected
    41
    deaths Num At Risk
    79
    description
    Participants who received placebo matched to vandetanib during the blinded randomized treatment period and who were unblinded due to disease progression or as a result of protocol amendment 6 were given the option to receive vandetanib 300 mg orally once daily in the open-label treatment period for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.
    id
    EG003
    other Num Affected
    70
    other Num At Risk
    79
    serious Num Affected
    36
    serious Num At Risk
    79
    title
    Open-Label Treatment Period: Placebo/Vandetanib 300 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      231
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      99
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      5
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      231
      num Events
      19
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      231
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Corneal Opacity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      231
      num Events
      23
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      99
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      5
    term
    Vision Blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      231
      num Events
      50
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      6
    term
    Abdominal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      231
      num Events
      33
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      99
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      79
      num Events
      5
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      231
      num Events
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      109
      num Events
      3
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      79
      num Events
      9
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      231
      num Events
      180
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      99
      num Events
      36
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      79
      num Events
      39
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      231
      num Events
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      99
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      79
      num Events
      7
    term
    Dry Mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      231
      num Events
      33
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      99
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      79
      num Events
      4
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      231
      num Events
      97
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      99
      num Events
      16
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      79
      num Events
      24
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      231
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      99
      num Events
      17
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Toothache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Disseminated Intravascular Coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Acute Myocardial Infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      231
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Atrial Fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      79
      num Events
      1
    term
    Bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardiac Failure Acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardiac Failure Congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      231
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardio-Respiratory Arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 13 - 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      231
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      99
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      79
      num Events
      0
    term
    Cardiovascular Insufficiency
time Frame
Serious adverse events(SAEs) and all-cause mortality(deaths) were collected from randomization (Day 1) up to end of follow-up, approximately 212 months. Other (non-serious) AEs were reported from randomization (Day 1) up to data cut-off date 01-Jun-2010, approximately 42 months. AEs and SAEs were collected from Day 1 to cut-off date 01-Jun-2010 and were presented in clinical database. After this cut-off date, SAEs were reported in pharmacovigilance database, but no non-serious AEs were reported.

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