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NCT03682536 · ADVERSE EVENTS

Adverse events

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20

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 was assessed from a participants first dose to primary completion (up to approximately 221 weeks). SAEs and Other AEs were assessed from first dose to 42 days post last dose (up to approximately an average of 72 weeks and a maximum of 208 weeks).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

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

Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.

82 / 182153 / 18239 / 182
Epoetin Alfa

Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).

71 / 179134 / 17938 / 181

Group identifiers: EG000: Luspatercept · EG001: Epoetin Alfa

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
    25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Bundle branch block left
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Cardiac arrest

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
    25.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      179
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      179
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      179
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      179
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      179
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      179
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      179
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      179
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      179
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      179
    term
    COVID-19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      179
    term
    Upper respiratory tract infection
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    39
    deaths Num At Risk
    182
    description
    Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
    id
    EG000
    other Num Affected
    153
    other Num At Risk
    182
    serious Num Affected
    82
    serious Num At Risk
    182
    title
    Luspatercept
  2. deaths Num Affected
    38
    deaths Num At Risk
    181
    description
    Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
    id
    EG001
    other Num Affected
    134
    other Num At Risk
    179
    serious Num Affected
    71
    serious Num At Risk
    179
    title
    Epoetin Alfa
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      179
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      179
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      179
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      179
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      179
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      179
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      179
    term
    Asthenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      179
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      179
    term
    Oedema peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      179
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      179
    term
    COVID-19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      179
    term
    Upper respiratory tract infection
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      179
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Angina pectoris
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      179
    term
    Bundle branch block left
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      182
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      179
    term
    Cardiac arrest
time Frame
All-cause mortality was assessed from a participants first dose to primary completion (up to approximately 221 weeks). SAEs and Other AEs were assessed from first dose to 42 days post last dose (up to approximately an average of 72 weeks and a maximum of 208 weeks).

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