Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05169567 · ADVERSE EVENTS

Adverse events

Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer · Source last updated 2026-01-16

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
Baseline up to 22 months
Other-event reporting threshold
5%

All participants who received at least one dose of the study drug, regardless of their eligibility for the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Abemaciclib Plus Fulvestrant

Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.

44 / 181173 / 18140 / 181
Arm B: Placebo Plus Fulvestrant

Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.

20 / 185131 / 18537 / 185

Group identifiers: EG000: Arm A: Abemaciclib Plus Fulvestrant · EG001: Arm B: Placebo Plus Fulvestrant

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Stress cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      181
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Gastric haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      181
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Gastritis

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      181
      num Events
      87
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      185
      num Events
      36
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      181
      num Events
      48
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      185
      num Events
      6
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      181
      num Events
      30
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      185
      num Events
      6
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      181
      num Events
      130
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      185
      num Events
      8
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      181
      num Events
      47
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      185
      num Events
      12
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      181
      num Events
      46
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      185
      num Events
      40
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      181
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      185
      num Events
      12
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      181
      num Events
      307
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      185
      num Events
      46
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      181
      num Events
      75
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      185
      num Events
      43
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      181
      num Events
      46
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      185
      num Events
      13
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      181
      num Events
      66
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      185
      num Events
      52
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      181
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      185
      num Events
      4
    term
    Oedema peripheral
Complete source fields
description
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
event Groups
  1. deaths Num Affected
    40
    deaths Num At Risk
    181
    description
    Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
    id
    EG000
    other Num Affected
    173
    other Num At Risk
    181
    serious Num Affected
    44
    serious Num At Risk
    181
    title
    Arm A: Abemaciclib Plus Fulvestrant
  2. deaths Num Affected
    37
    deaths Num At Risk
    185
    description
    Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
    id
    EG001
    other Num Affected
    131
    other Num At Risk
    185
    serious Num Affected
    20
    serious Num At Risk
    185
    title
    Arm B: Placebo Plus Fulvestrant
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      181
      num Events
      87
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      185
      num Events
      36
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      181
      num Events
      48
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      185
      num Events
      6
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      181
      num Events
      30
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      185
      num Events
      6
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      181
      num Events
      130
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      185
      num Events
      8
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      181
      num Events
      47
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      185
      num Events
      12
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      181
      num Events
      46
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      185
      num Events
      40
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      181
      num Events
      15
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      185
      num Events
      12
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      181
      num Events
      307
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      185
      num Events
      46
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      181
      num Events
      75
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      185
      num Events
      43
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      181
      num Events
      46
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      185
      num Events
      13
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      181
      num Events
      66
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      185
      num Events
      52
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      181
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      185
      num Events
      4
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Coronary artery disease
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Stress cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      181
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      181
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      181
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      185
      num Events
      0
    term
    Gastric haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      181
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      185
      num Events
      1
    term
    Gastritis
time Frame
Baseline up to 22 months

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

Preserved source evidence · Not medical advice