Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02513394 · ADVERSE EVENTS

Adverse events

PALbociclib CoLlaborative Adjuvant Study · Source last updated 2026-06-15

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
4 years
Other-event reporting threshold
0%

The safety analysis is conducted in the "as-treated" population. Patients randomly assigned to the Arm A who never received Palbociclib but received endocrine therapy (N=36) were included in Arm B for the safety analyses. Thus, the safety analysis included 2841 patients who received at least one dose of Palbociclib plus endocrine therapy and 2902 patients who received endocrine therapy (which included 36 patients from Arm A who received endocrine therapy only).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Palbociclib Plus Endocrine Therapy (Arm A)

Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

369 / 28412824 / 284199 / 2841
Endocrine Therapy Alone (Arm B)

Standard adjuvant endocrine therapy for a duration of at least 5 years.

229 / 29022600 / 290276 / 2902

Group identifiers: EG000: Palbociclib Plus Endocrine Therapy (Arm A) · EG001: Endocrine Therapy Alone (Arm B)

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2841
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      2841
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2841
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Lymphadenitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      2841
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Splenic infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2902
      num Events
      2
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Arteriospasm coronary

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
    Psychiatric disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Agitation Mood Disturbance
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Veritgo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2841
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Agranulocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      634
      num At Risk
      2841
      num Events
      1161
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      2902
      num Events
      211
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      2841
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Anaemia macrocytic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Anaemia vitamin B12 deficiency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Blood disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      2
    term
    Bone marrow oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2902
      num Events
      2
    term
    Eosinophilia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      2841
      num Events
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Haematotoxicity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2841
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Haemorrhagic diathesis
Complete source fields
description
The safety analysis is conducted in the "as-treated" population. Patients randomly assigned to the Arm A who never received Palbociclib but received endocrine therapy (N=36) were included in Arm B for the safety analyses. Thus, the safety analysis included 2841 patients who received at least one dose of Palbociclib plus endocrine therapy and 2902 patients who received endocrine therapy (which included 36 patients from Arm A who received endocrine therapy only).
event Groups
  1. deaths Num Affected
    99
    deaths Num At Risk
    2841
    description
    Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
    id
    EG000
    other Num Affected
    2824
    other Num At Risk
    2841
    serious Num Affected
    369
    serious Num At Risk
    2841
    title
    Palbociclib Plus Endocrine Therapy (Arm A)
  2. deaths Num Affected
    76
    deaths Num At Risk
    2902
    description
    Standard adjuvant endocrine therapy for a duration of at least 5 years.
    id
    EG001
    other Num Affected
    2600
    other Num At Risk
    2902
    serious Num Affected
    229
    serious Num At Risk
    2902
    title
    Endocrine Therapy Alone (Arm B)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Agitation Mood Disturbance
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Veritgo
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2841
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Agranulocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      634
      num At Risk
      2841
      num Events
      1161
    2. group Id
      EG001
      num Affected
      147
      num At Risk
      2902
      num Events
      211
    term
    Anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      2841
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Anaemia macrocytic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Anaemia vitamin B12 deficiency
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Blood disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      2
    term
    Bone marrow oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2902
      num Events
      2
    term
    Eosinophilia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      2841
      num Events
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Haematotoxicity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2841
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Haemorrhagic diathesis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      2841
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      2841
      num Events
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2841
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Lymphadenitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      2841
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Splenic infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2902
      num Events
      2
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2841
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2902
      num Events
      1
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2841
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2902
      num Events
      0
    term
    Arteriospasm coronary
time Frame
4 years

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

Preserved source evidence · Not medical advice