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NCT05654623 · ADVERSE EVENTS

Adverse events

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer · Source last updated 2026-03-18

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: From the first dose of study treatment up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively); All-cause mortality: From randomization until date of death due to any cause (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. AEs were monitored for safety analysis set. All-cause mortality was monitored for full analysis set

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Vepdegestrant (ARV-471)

Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.

32 / 312233 / 31245 / 313
Fulvestrant

Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.

28 / 307174 / 30735 / 311

Group identifiers: EG000: Vepdegestrant (ARV-471) · EG001: 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Arrhythmia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Cataract
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Dyspepsia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Ischaemic enteritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Large intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Malignant ascites
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Nausea

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      307
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      307
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      307
    term
    Diarrhoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      307
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      307
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      307
    term
    Asthenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      307
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      307
    term
    Injection site pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      307
    term
    Alanine aminotransferase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      307
    term
    Aspartate aminotransferase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      307
    term
    Blood bilirubin increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      307
    term
    Electrocardiogram QT prolonged
Complete source fields
description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. AEs were monitored for safety analysis set. All-cause mortality was monitored for full analysis set
event Groups
  1. deaths Num Affected
    45
    deaths Num At Risk
    313
    description
    Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    EG000
    other Num Affected
    233
    other Num At Risk
    312
    serious Num Affected
    32
    serious Num At Risk
    312
    title
    Vepdegestrant (ARV-471)
  2. deaths Num Affected
    35
    deaths Num At Risk
    311
    description
    Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    EG001
    other Num Affected
    174
    other Num At Risk
    307
    serious Num Affected
    28
    serious Num At Risk
    307
    title
    Fulvestrant
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      307
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      307
    term
    Constipation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      307
    term
    Diarrhoea
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      307
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      307
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      307
    term
    Asthenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      307
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      307
    term
    Injection site pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      307
    term
    Alanine aminotransferase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      307
    term
    Aspartate aminotransferase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      307
    term
    Blood bilirubin increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      307
    term
    Electrocardiogram QT prolonged
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      307
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Arrhythmia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Cataract
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Colitis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Dyspepsia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Ischaemic enteritis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Large intestinal obstruction
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      307
    term
    Malignant ascites
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      312
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      307
    term
    Nausea
time Frame
Adverse events: From the first dose of study treatment up to 28 days after last dose of study treatment (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively); All-cause mortality: From randomization until date of death due to any cause (up to 19.56 months and 20.38 months for vepdegestrant and fulvestrant arms respectively)

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