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NCT05546476 · ADVERSE EVENTS

Adverse events

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 · Source last updated 2026-06-03

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
Part A: from the first dose of study drug until first dose of open label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A). Part B: from the first dose of open label ponsegromab 400 mg up to approximately Week 72 (including 8 weeks follow up post last dose in Part B)
Other-event reporting threshold
5%

Same event may appear as non-SAE and SAE; what is presented are distinct events. Event may be categorized serious in 1 participant and non-serious in another, or participant may have experienced both serious and non-serious event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A: Placebo

Participants received placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).

11 / 4526 / 455 / 45
Part A: Ponsegromab 100 mg

Participants received Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).

15 / 4622 / 466 / 46
Part A: Ponsegromab 200 mg

Participants received Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).

10 / 4619 / 466 / 46
Part A: Ponsegromab 400 mg

Participants received Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).

20 / 5024 / 509 / 50
Part A: Placebo/ Part B: Ponsegromab 400 mg

Participants who received placebo had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.

9 / 2416 / 248 / 24
Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg

Participants who received Ponsegromab 100 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.

14 / 2722 / 2710 / 27
Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg

Participants who received Ponsegromab 200 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.

16 / 3424 / 3413 / 34
Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg

Participants who received Ponsegromab 400 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.

11 / 2919 / 295 / 29

Group identifiers: EG000: Part A: Placebo · EG001: Part A: Ponsegromab 100 mg · EG002: Part A: Ponsegromab 200 mg · EG003: Part A: Ponsegromab 400 mg · EG004: Part A: Placebo/ Part B: Ponsegromab 400 mg · EG005: Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg · EG006: Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg · EG007: Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg

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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Febrile neutropenia
  3. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Neutropenia
  4. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Thrombocytopenia
  5. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Angina pectoris
  6. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Cardiac failure
  7. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Cardiopulmonary failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Myocardial infarction
  9. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Tachycardia
  10. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Abdominal adhesions
  11. 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
      45
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain
  12. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Anal fistula

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
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Anaemia
  2. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Neutropenia
  3. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Abdominal distension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Abdominal pain
  5. 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
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain upper
  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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Ascites
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      29
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      29
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Nausea
  10. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Stomatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Asthenia
Complete source fields
description
Same event may appear as non-SAE and SAE; what is presented are distinct events. Event may be categorized serious in 1 participant and non-serious in another, or participant may have experienced both serious and non-serious event. Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    45
    description
    Participants received placebo matching to Ponsegromab SC Q4W up to 12 weeks (total of 3 doses).
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    45
    serious Num Affected
    11
    serious Num At Risk
    45
    title
    Part A: Placebo
  2. deaths Num Affected
    6
    deaths Num At Risk
    46
    description
    Participants received Ponsegromab 100 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    46
    serious Num Affected
    15
    serious Num At Risk
    46
    title
    Part A: Ponsegromab 100 mg
  3. deaths Num Affected
    6
    deaths Num At Risk
    46
    description
    Participants received Ponsegromab 200 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    EG002
    other Num Affected
    19
    other Num At Risk
    46
    serious Num Affected
    10
    serious Num At Risk
    46
    title
    Part A: Ponsegromab 200 mg
  4. deaths Num Affected
    9
    deaths Num At Risk
    50
    description
    Participants received Ponsegromab 400 mg SC Q4W up to 12 weeks (total of 3 doses).
    id
    EG003
    other Num Affected
    24
    other Num At Risk
    50
    serious Num Affected
    20
    serious Num At Risk
    50
    title
    Part A: Ponsegromab 400 mg
  5. deaths Num Affected
    8
    deaths Num At Risk
    24
    description
    Participants who received placebo had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.
    id
    EG004
    other Num Affected
    16
    other Num At Risk
    24
    serious Num Affected
    9
    serious Num At Risk
    24
    title
    Part A: Placebo/ Part B: Ponsegromab 400 mg
  6. deaths Num Affected
    10
    deaths Num At Risk
    27
    description
    Participants who received Ponsegromab 100 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.
    id
    EG005
    other Num Affected
    22
    other Num At Risk
    27
    serious Num Affected
    14
    serious Num At Risk
    27
    title
    Part A: Ponsegromab 100 mg/ Part B: Ponsegromab 400 mg
  7. deaths Num Affected
    13
    deaths Num At Risk
    34
    description
    Participants who received Ponsegromab 200 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.
    id
    EG006
    other Num Affected
    24
    other Num At Risk
    34
    serious Num Affected
    16
    serious Num At Risk
    34
    title
    Part A: Ponsegromab 200 mg/ Part B: Ponsegromab 400 mg
  8. deaths Num Affected
    5
    deaths Num At Risk
    29
    description
    Participants who received Ponsegromab 400 mg had the opportunity to receive open label Ponsegromab 400 mg Q4W SC for up to 1 year on completion of Part A.
    id
    EG007
    other Num Affected
    19
    other Num At Risk
    29
    serious Num Affected
    11
    serious Num At Risk
    29
    title
    Part A: Ponsegromab 400 mg/ Part B: Ponsegromab 400 mg
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
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Anaemia
  2. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Neutropenia
  3. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Abdominal distension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Abdominal pain
  5. 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
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain upper
  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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Ascites
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      29
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      29
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Nausea
  10. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Stomatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Asthenia
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
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Febrile neutropenia
  3. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Neutropenia
  4. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Thrombocytopenia
  5. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Angina pectoris
  6. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Cardiac failure
  7. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Cardiopulmonary failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Myocardial infarction
  9. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Tachycardia
  10. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      29
    term
    Abdominal adhesions
  11. 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
      45
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Abdominal pain
  12. 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
      45
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      50
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      24
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      27
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      34
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      29
    term
    Anal fistula
time Frame
Part A: from the first dose of study drug until first dose of open label ponsegromab 400 mg for participants entering Part B or through Week 16 follow-up for participants not entering Part B (including 8 weeks of follow-up from last dose of study drug in part A). Part B: from the first dose of open label ponsegromab 400 mg up to approximately Week 72 (including 8 weeks follow up post last dose in Part B)

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Preserved source evidence · Not medical advice