Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04173494 · ADVERSE EVENTS

Adverse events

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) · Source last updated 2023-11-01

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, Serious adverse events (SAEs) and non-SAEs were collected up to Week 24 for Randomized Double-Blind Treatment Period and From Week 24 to a maximum of 151 weeks for the Open-Label Extended Treatment Period
Other-event reporting threshold
5%

Serious adverse events (SAEs) and non-SAEs were measured in the Safety analysis set, which included all participants in the ITT analysis set who received at least one dose of study drug. All-cause mortality was measured in the ITT analysis set, which included all randomized participants. Data are presented per treatment received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period

Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.

45 / 130108 / 13025 / 130
DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period

Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period.

26 / 6555 / 6516 / 65
MMB 200 mg QD- Open-Label Extended Treatment Period

Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period.

30 / 9357 / 9323 / 93
DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period

Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.

12 / 4128 / 418 / 41

Group identifiers: EG000: MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period · EG001: DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period · EG002: MMB 200 mg QD- Open-Label Extended Treatment Period · EG003: DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period

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 v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      130
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      65
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Blood loss anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      93
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Splenic haematoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Splenic infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Splenic vein thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      130
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      130
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Cardiogenic shock
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Coronary artery disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Coronary artery stenosis

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 v24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      130
      num Events
      34
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      11
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      93
      num Events
      18
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      41
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      130
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      93
      num Events
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      130
      num Events
      50
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
      num Events
      11
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      93
      num Events
      22
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      41
      num Events
      10
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      130
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      130
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      65
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      130
      num Events
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      65
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      93
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      130
      num Events
      40
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      7
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      93
      num Events
      21
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      41
      num Events
      7
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      130
      num Events
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      6
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      93
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      130
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      130
      num Events
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      8
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      93
      num Events
      15
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      130
      num Events
      10
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      93
      num Events
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      130
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      65
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Oedema peripheral
Complete source fields
description
Serious adverse events (SAEs) and non-SAEs were measured in the Safety analysis set, which included all participants in the ITT analysis set who received at least one dose of study drug. All-cause mortality was measured in the ITT analysis set, which included all randomized participants. Data are presented per treatment received.
event Groups
  1. deaths Num Affected
    25
    deaths Num At Risk
    130
    description
    Participants were randomized to receive 200 mg of MMB orally QD and a DAN-placebo orally BID during the randomized 24-week double-blind treatment period.
    id
    EG000
    other Num Affected
    108
    other Num At Risk
    130
    serious Num Affected
    45
    serious Num At Risk
    130
    title
    MMB 200 mg QD + Placebo- Randomized Double-Blind Treatment Period
  2. deaths Num Affected
    16
    deaths Num At Risk
    65
    description
    Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period.
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    65
    serious Num Affected
    26
    serious Num At Risk
    65
    title
    DAN 300 mg BID + Placebo- Randomized Double-Blind Treatment Period
  3. deaths Num Affected
    23
    deaths Num At Risk
    93
    description
    Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period.
    id
    EG002
    other Num Affected
    57
    other Num At Risk
    93
    serious Num Affected
    30
    serious Num At Risk
    93
    title
    MMB 200 mg QD- Open-Label Extended Treatment Period
  4. deaths Num Affected
    8
    deaths Num At Risk
    41
    description
    Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.
    id
    EG003
    other Num Affected
    28
    other Num At Risk
    41
    serious Num Affected
    12
    serious Num At Risk
    41
    title
    DAN 300 mg BID to MMB 200 mg QD- Open-Label Extended Treatment Period
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      130
      num Events
      34
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      11
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      93
      num Events
      18
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      41
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      130
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      93
      num Events
      9
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      130
      num Events
      50
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      65
      num Events
      11
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      93
      num Events
      22
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      41
      num Events
      10
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      130
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      130
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      65
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Abdominal pain upper
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      130
      num Events
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      65
      num Events
      5
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      93
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      130
      num Events
      40
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      7
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      93
      num Events
      21
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      41
      num Events
      7
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      130
      num Events
      28
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      6
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      93
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      130
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      130
      num Events
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      8
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      93
      num Events
      15
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      130
      num Events
      10
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      65
      num Events
      10
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      93
      num Events
      11
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      130
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      65
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      93
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      130
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      65
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Blood loss anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      93
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Splenic haematoma
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      65
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Splenic infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Splenic vein thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      130
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      130
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      130
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      65
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Cardiogenic shock
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      93
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Coronary artery disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      130
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      65
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      93
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      41
      num Events
      0
    term
    Coronary artery stenosis
time Frame
All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 24 for Randomized Double-Blind Treatment Period and From Week 24 to a maximum of 151 weeks for the Open-Label Extended Treatment Period

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice