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NCT03778931 · ADVERSE EVENTS

Adverse events

Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer · Source last updated 2025-09-15

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
24 months
Other-event reporting threshold
5%

All-Cause Mortality, Progression-free Survival, and Overall Survival were assessed with the Intention-to-Treat Population, which consisted of all randomized participants. Adverse Events (Serious and Other) reporting reflects the Safety Population, which consisted of all participants who received at least 1 dose of study medication. All deaths regardless of causality are reported in the All-Cause Mortality section. Only deaths leading to study discontinuation are reported in the Participant Flow.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Elacestrant

Participants in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing

29 / 237215 / 23770 / 239
Standard of Care (SoC)

Participants in Arm 2 will receive Investigator's choice of one of the Standard-of-Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: * Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle * Anastrozole 1 mg/day on a continuous dosing schedule * Letrozole: 2.5 mg/day on a continuous dosing schedule * Exemestane: 25 mg/day on a continuous dosing schedule

25 / 230195 / 23080 / 239

Group identifiers: EG000: Elacestrant · EG001: Standard of Care (SoC)

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Antiphospholipid syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Small intestinal obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      230
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Enteritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Ileus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    General physical health deterioration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Cholecystitis acute

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      230
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      230
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      230
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      230
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      230
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      230
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      230
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      230
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      230
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      230
    term
    Injection site pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      230
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      230
    term
    Aspartate aminotransferase increased
Complete source fields
description
All-Cause Mortality, Progression-free Survival, and Overall Survival were assessed with the Intention-to-Treat Population, which consisted of all randomized participants. Adverse Events (Serious and Other) reporting reflects the Safety Population, which consisted of all participants who received at least 1 dose of study medication. All deaths regardless of causality are reported in the All-Cause Mortality section. Only deaths leading to study discontinuation are reported in the Participant Flow.
event Groups
  1. deaths Num Affected
    70
    deaths Num At Risk
    239
    description
    Participants in Arm 1 will receive elacestrant Elacestrant: 400 mg/day once daily oral dosing
    id
    EG000
    other Num Affected
    215
    other Num At Risk
    237
    serious Num Affected
    29
    serious Num At Risk
    237
    title
    Elacestrant
  2. deaths Num Affected
    80
    deaths Num At Risk
    239
    description
    Participants in Arm 2 will receive Investigator's choice of one of the Standard-of-Care drugs (fulvestrant, anastrozole, letrozole, or exemestane) Standard of Care: * Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle * Anastrozole 1 mg/day on a continuous dosing schedule * Letrozole: 2.5 mg/day on a continuous dosing schedule * Exemestane: 25 mg/day on a continuous dosing schedule
    id
    EG001
    other Num Affected
    195
    other Num At Risk
    230
    serious Num Affected
    25
    serious Num At Risk
    230
    title
    Standard of Care (SoC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      230
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      230
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      230
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      230
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      230
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      230
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      230
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      230
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      230
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      230
    term
    Injection site pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      230
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      230
    term
    Aspartate aminotransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Antiphospholipid syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Small intestinal obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      230
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Enteritis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Ileus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    General physical health deterioration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      237
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Cholecystitis acute
time Frame
24 months

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