Skip to content
← Full study record

NCT01969838 · ADVERSE EVENTS

Adverse events

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis · Source last updated 2023-05-12

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
Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.
Other-event reporting threshold
5%

The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Momelotinib (MMB)

Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.

49 / 214197 / 2148 / 214
Ruxolitinib (RUX)

Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.

39 / 216206 / 2166 / 216
MMB to MMB

After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.

79 / 171153 / 17144 / 171
RUX to MMB

After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.

79 / 197188 / 19754 / 197

Group identifiers: EG000: Momelotinib (MMB) · EG001: Ruxolitinib (RUX) · EG002: MMB to MMB · EG003: RUX to MMB

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 (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      197
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Haemolytic anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      197
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Microangiopathic haemolytic anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      197
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      197
    term
    Splenic haematoma
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Splenic infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Splenic thrombosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      197
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Thrombocytosis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      197
    term
    Acute myocardial infarction

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      197
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      197
    term
    Alanine aminotransferase increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      197
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      197
    term
    Arthralgia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      197
    term
    Asthenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      197
    term
    Back pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      197
    term
    Blood creatinine increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      197
    term
    Bone pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      197
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      197
    term
    Contusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      197
    term
    Cough
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      197
    term
    Decreased appetite
Complete source fields
description
The safety population did not include 2 patients (one on MMB and one on RUX) who were not dosed, hence affecting the total number of patients at risk.
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    214
    description
    Participants received momelotinib plus placebo to match ruxolitinib. Momelotinib tablets were administered orally once daily at a starting dose of 200 mg. Additional available strengths included 100 mg and 150 mg. Placebo to match ruxolitinib tablets were administered orally twice daily.
    id
    EG000
    other Num Affected
    197
    other Num At Risk
    214
    serious Num Affected
    49
    serious Num At Risk
    214
    title
    Momelotinib (MMB)
  2. deaths Num Affected
    6
    deaths Num At Risk
    216
    description
    Participants received ruxolitinib plus placebo to match momelotinib. Ruxolitinib tablets were administered orally twice daily. The dose ranged from 5 to 20 mg BID and was dependent on platelet count, creatinine clearance, and transaminase levels. Placebo to match momelotinib tablets were administered orally once daily.
    id
    EG001
    other Num Affected
    206
    other Num At Risk
    216
    serious Num Affected
    39
    serious Num At Risk
    216
    title
    Ruxolitinib (RUX)
  3. deaths Num Affected
    44
    deaths Num At Risk
    171
    description
    After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the MMB group at study entry continued MMB in the open-label treatment phase at their current dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
    id
    EG002
    other Num Affected
    153
    other Num At Risk
    171
    serious Num Affected
    79
    serious Num At Risk
    171
    title
    MMB to MMB
  4. deaths Num Affected
    54
    deaths Num At Risk
    197
    description
    After completion of the 24-week double-blind treatment phase, participants had the option to receive MMB in an open-label treatment phase for up to an additional 216 weeks. Participants randomized to the RUX group who wished to remain in the study initiated MMB in the open-label treatment phase at the dose matching their equivalent MMB placebo dose. Available MMB strengths were 100 mg, 150 mg and 200 mg.
    id
    EG003
    other Num Affected
    188
    other Num At Risk
    197
    serious Num Affected
    79
    serious Num At Risk
    197
    title
    RUX to MMB
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      197
    term
    Abdominal pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      197
    term
    Alanine aminotransferase increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      197
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      197
    term
    Arthralgia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      197
    term
    Asthenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      197
    term
    Back pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      197
    term
    Blood creatinine increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      197
    term
    Bone pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      197
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      197
    term
    Contusion
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      34
      num At Risk
      197
    term
    Cough
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      197
    term
    Decreased appetite
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      197
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Haemolytic anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      197
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Microangiopathic haemolytic anaemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      197
    term
    Neutropenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      197
    term
    Splenic haematoma
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Splenic infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Splenic thrombosis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      197
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      197
    term
    Thrombocytosis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (22.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      214
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      216
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      171
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      197
    term
    Acute myocardial infarction
time Frame
Serious and other Adverse events were recorded that occurred from initiation of investigational product (IP) until 30 days after the last administration of IP regardless of cause or relationship. Serious events are monitored up to 12 weeks and all-cause mortality was assessed for up to 5 years.

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

Preserved source evidence · Not medical advice