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NCT02437318 · ADVERSE EVENTS

Adverse events

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. · Source last updated 2025-02-13

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
All-cause mortality: from randomization up to approx. 6.5 years, including post-treatment survival follow up period. Serious and Other Adverse Events: from first dose of study treatment until 30 days after last dose up to approx. 6.5 years
Other-event reporting threshold
5%

All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other Adverse Events: reported for all randomized participants who received any amount of study treatment

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Alpelisib + Fulvestrant

All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.

110 / 284280 / 2849 / 284
Placebo + Fulvestrant

All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.

54 / 287244 / 28712 / 288
Alpelisib + Fulvestrant (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period

0 / 00 / 0151 / 275
Placebo + Fulvestrant (Post-treatment Survival Follow-up)

Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period

0 / 00 / 0156 / 275

Group identifiers: EG000: Alpelisib + Fulvestrant · EG001: Placebo + Fulvestrant · EG002: Alpelisib + Fulvestrant (Post-treatment Survival Follow-up) · EG003: Placebo + Fulvestrant (Post-treatment Survival Follow-up)

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 (26.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Thrombotic microangiopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Arteriospasm coronary
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Pericardial effusion

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 (26.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Vision blurred
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      133
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Asthenia
Complete source fields
description
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other Adverse Events: reported for all randomized participants who received any amount of study treatment
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    284
    description
    All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.
    id
    EG000
    other Num Affected
    280
    other Num At Risk
    284
    serious Num Affected
    110
    serious Num At Risk
    284
    title
    Alpelisib + Fulvestrant
  2. deaths Num Affected
    12
    deaths Num At Risk
    288
    description
    All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.
    id
    EG001
    other Num Affected
    244
    other Num At Risk
    287
    serious Num Affected
    54
    serious Num At Risk
    287
    title
    Placebo + Fulvestrant
  3. deaths Num Affected
    151
    deaths Num At Risk
    275
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Alpelisib + Fulvestrant (Post-treatment Survival Follow-up)
  4. deaths Num Affected
    156
    deaths Num At Risk
    275
    description
    Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Placebo + Fulvestrant (Post-treatment Survival Follow-up)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Vision blurred
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      133
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Thrombotic microangiopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Arteriospasm coronary
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (26.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      284
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      287
    3. group Id
      EG002
      num At Risk
      0
    4. group Id
      EG003
      num At Risk
      0
    term
    Pericardial effusion
time Frame
All-cause mortality: from randomization up to approx. 6.5 years, including post-treatment survival follow up period. Serious and Other Adverse Events: from first dose of study treatment until 30 days after last dose up to approx. 6.5 years

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Preserved source evidence · Not medical advice