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NCT04266301 · ADVERSE EVENTS

Adverse events

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

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 (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 43.5 months (sabatolimab plus AZA) and 42.6 months (placebo + AZA). Deaths were collected from randomization until end of trial, approx. 52 months.
Other-event reporting threshold
5%

Adverse Event: Any sign or symptom that occurs during the study treatment + 30 days post treatment. All-Cause Mortality is based on all randomized participants (by randomized study treatment), Serious and Other Adverse Events are summarized for the participants who received study treatment (by study treatment received).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sabatolimab (MBG453) + Azacitidine

Participants received sabatolimab plus Azacitidine

174 / 263256 / 263161 / 265
Placebo + Azacitidine

Participants received placebo plus Azacitidine

164 / 265255 / 265160 / 265

Group identifiers: EG000: Sabatolimab (MBG453) + Azacitidine · EG001: Placebo + Azacitidine

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 (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      265
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      265
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Anaemia of malignant disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Aplastic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Autoimmune haemolytic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Disseminated intravascular coagulation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Febrile bone marrow aplasia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      265
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Iron deficiency anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Leukocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Lymphadenitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      265
    term
    Myelosuppression

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 (27.1)
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      265
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      265
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      265
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      265
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      265
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      265
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      141
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      265
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      265
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      265
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      265
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      265
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      265
    term
    Asthenia
Complete source fields
description
Adverse Event: Any sign or symptom that occurs during the study treatment + 30 days post treatment. All-Cause Mortality is based on all randomized participants (by randomized study treatment), Serious and Other Adverse Events are summarized for the participants who received study treatment (by study treatment received).
event Groups
  1. deaths Num Affected
    161
    deaths Num At Risk
    265
    description
    Participants received sabatolimab plus Azacitidine
    id
    EG000
    other Num Affected
    256
    other Num At Risk
    263
    serious Num Affected
    174
    serious Num At Risk
    263
    title
    Sabatolimab (MBG453) + Azacitidine
  2. deaths Num Affected
    160
    deaths Num At Risk
    265
    description
    Participants received placebo plus Azacitidine
    id
    EG001
    other Num Affected
    255
    other Num At Risk
    265
    serious Num Affected
    164
    serious Num At Risk
    265
    title
    Placebo + Azacitidine
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      91
      num At Risk
      265
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      265
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      265
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      265
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      265
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      265
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      141
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      265
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      265
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      265
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      265
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      265
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      265
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      265
    term
    Agranulocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      265
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Anaemia of malignant disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Aplastic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Autoimmune haemolytic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Disseminated intravascular coagulation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Febrile bone marrow aplasia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      265
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Iron deficiency anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      265
    term
    Leukocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      265
    term
    Lymphadenitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      263
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      265
    term
    Myelosuppression
time Frame
Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 43.5 months (sabatolimab plus AZA) and 42.6 months (placebo + AZA). Deaths were collected from randomization until end of trial, approx. 52 months.

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