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NCT04305496 · ADVERSE EVENTS

Adverse events

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer · Source last updated 2026-04-30

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
Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.
Other-event reporting threshold
5%

Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Capi (Global Cohort)

Description (Arm-group)

57 / 355334 / 3554 / 355
Placebo (Global Cohort)

Description (Arm-group)

28 / 350255 / 3501 / 350
Capi (China Cohort)

Description (Arm-group)

20 / 7167 / 711 / 71
Placebo (China Cohort)

Description (Arm-group)

3 / 6252 / 620 / 62

Group identifiers: EG000: Capi (Global Cohort) · EG001: Placebo (Global Cohort) · EG002: Capi (China Cohort) · EG003: Placebo (China Cohort)

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
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Non-small cell lung cancer
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Small cell lung cancer
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Tumour associated fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Uterine leiomyoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Cerebral haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Cerebral infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Cerebrovascular accident
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Dizziness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Confusional state

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
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    term
    Dysgeusia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    term
    Insomnia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      62
    term
    Proteinuria
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      62
    term
    Cough
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      62
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      62
    term
    Dyspnoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Oropharyngeal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Dry skin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      255
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      62
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Erythema
Complete source fields
description
Full analysis set is included for mortality rate, but safety analysis set is included other SAEs/nonserious AEs. An AE was development of any untoward medical occurrence/deterioration of preexisting medical occurrence in a participant administered medicinal product, which did not necessarily have a causal relationship with treatment, including SAEs and non-serious AEs. AEs of special interest were identified and actively monitored. Only fatal AEs are presented for all-cause mortality.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    355
    description
    Description (Arm-group)
    id
    EG000
    other Num Affected
    334
    other Num At Risk
    355
    serious Num Affected
    57
    serious Num At Risk
    355
    title
    Capi (Global Cohort)
  2. deaths Num Affected
    1
    deaths Num At Risk
    350
    description
    Description (Arm-group)
    id
    EG001
    other Num Affected
    255
    other Num At Risk
    350
    serious Num Affected
    28
    serious Num At Risk
    350
    title
    Placebo (Global Cohort)
  3. deaths Num Affected
    1
    deaths Num At Risk
    71
    description
    Description (Arm-group)
    id
    EG002
    other Num Affected
    67
    other Num At Risk
    71
    serious Num Affected
    20
    serious Num At Risk
    71
    title
    Capi (China Cohort)
  4. deaths Num Affected
    0
    deaths Num At Risk
    62
    description
    Description (Arm-group)
    id
    EG003
    other Num Affected
    52
    other Num At Risk
    62
    serious Num Affected
    3
    serious Num At Risk
    62
    title
    Placebo (China Cohort)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    term
    Dysgeusia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    term
    Headache
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    term
    Insomnia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      62
    term
    Proteinuria
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      62
    term
    Cough
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      62
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      62
    term
    Dyspnoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Oropharyngeal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Dry skin
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      255
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      62
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Erythema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Non-small cell lung cancer
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Small cell lung cancer
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Tumour associated fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Uterine leiomyoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Cerebral haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Cerebral infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Cerebrovascular accident
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Dizziness
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Syncope
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      355
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    term
    Confusional state
time Frame
Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.

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Preserved source evidence · Not medical advice