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NCT01437787 · ADVERSE EVENTS

Adverse events

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis · Source last updated 2026-08-11

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 Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product.
Other-event reporting threshold
5%

Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.

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

Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.

22 / 9576 / 956 / 96
SAR302503 400 mg

SAR302503 400 mg (from first dose after initial randomization to the end of study, median duration of exposure= 62.1 weeks).

37 / 9696 / 965 / 96
SAR302503 500 mg

SAR302503 500 mg (from first dose after intial randomization to the end of study, median duration of exposure= 59.7 weeks).

43 / 9794 / 976 / 97
SAR302503 400 mg After Cross-over

SAR302503 400 mg (from first dose after re-randomization to the end of study, median duration of exposure= 43.9 weeks).

13 / 3533 / 350 / 35
SAR302503 500 mg After Cross-over

SAR302503 500 mg (from first dose after re-randomization to the end of study, median duration of exposure= 44.2 weeks).

13 / 3636 / 361 / 36

Group identifiers: EG000: Placebo · EG001: SAR302503 400 mg · EG002: SAR302503 500 mg · EG003: SAR302503 400 mg After Cross-over · EG004: SAR302503 500 mg After Cross-over

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 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      96
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      97
      num Events
      23
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Disseminated Intravascular Coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Haemorrhagic Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      97
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      97
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Splenic Haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      97
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Splenic Infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Splenomegaly
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      97
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute Coronary Syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute Left Ventricular Failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      97
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      95
      num Events
      15
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      96
      num Events
      79
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      97
      num Events
      77
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      35
      num Events
      34
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      36
      num Events
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      97
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      96
      num Events
      10
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      97
      num Events
      17
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      6
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      95
      num Events
      9
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      96
      num Events
      22
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      97
      num Events
      28
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      35
      num Events
      9
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      36
      num Events
      13
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      97
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Abdominal Discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      96
      num Events
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      97
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Abdominal Distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      95
      num Events
      17
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      96
      num Events
      23
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      97
      num Events
      19
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      35
      num Events
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      36
      num Events
      7
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      95
      num Events
      6
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      96
      num Events
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      97
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      36
      num Events
      4
    term
    Abdominal Pain Upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      95
      num Events
      7
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      96
      num Events
      13
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      97
      num Events
      23
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      35
      num Events
      8
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      95
      num Events
      19
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      96
      num Events
      106
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      97
      num Events
      87
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      35
      num Events
      15
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      36
      num Events
      18
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      96
      num Events
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      97
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Dyspepsia
Complete source fields
description
Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened or deaths that occurred during the 'on treatment period' (from the first dose of IMP up to 30 days after the last dose). Data collected from all treated participants.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    96
    description
    Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    76
    other Num At Risk
    95
    serious Num Affected
    22
    serious Num At Risk
    95
    title
    Placebo
  2. deaths Num Affected
    5
    deaths Num At Risk
    96
    description
    SAR302503 400 mg (from first dose after initial randomization to the end of study, median duration of exposure= 62.1 weeks).
    id
    EG001
    other Num Affected
    96
    other Num At Risk
    96
    serious Num Affected
    37
    serious Num At Risk
    96
    title
    SAR302503 400 mg
  3. deaths Num Affected
    6
    deaths Num At Risk
    97
    description
    SAR302503 500 mg (from first dose after intial randomization to the end of study, median duration of exposure= 59.7 weeks).
    id
    EG002
    other Num Affected
    94
    other Num At Risk
    97
    serious Num Affected
    43
    serious Num At Risk
    97
    title
    SAR302503 500 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    35
    description
    SAR302503 400 mg (from first dose after re-randomization to the end of study, median duration of exposure= 43.9 weeks).
    id
    EG003
    other Num Affected
    33
    other Num At Risk
    35
    serious Num Affected
    13
    serious Num At Risk
    35
    title
    SAR302503 400 mg After Cross-over
  5. deaths Num Affected
    1
    deaths Num At Risk
    36
    description
    SAR302503 500 mg (from first dose after re-randomization to the end of study, median duration of exposure= 44.2 weeks).
    id
    EG004
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    13
    serious Num At Risk
    36
    title
    SAR302503 500 mg After Cross-over
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      95
      num Events
      15
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      96
      num Events
      79
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      97
      num Events
      77
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      35
      num Events
      34
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      36
      num Events
      32
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      97
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      96
      num Events
      10
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      97
      num Events
      17
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      6
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      95
      num Events
      9
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      96
      num Events
      22
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      97
      num Events
      28
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      35
      num Events
      9
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      36
      num Events
      13
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      97
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      2
    term
    Abdominal Discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      96
      num Events
      6
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      97
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Abdominal Distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      95
      num Events
      17
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      96
      num Events
      23
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      97
      num Events
      19
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      35
      num Events
      5
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      36
      num Events
      7
    term
    Abdominal Pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      95
      num Events
      6
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      96
      num Events
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      97
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      36
      num Events
      4
    term
    Abdominal Pain Upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      95
      num Events
      7
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      96
      num Events
      13
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      97
      num Events
      23
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      35
      num Events
      8
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      36
      num Events
      3
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      95
      num Events
      19
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      96
      num Events
      106
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      97
      num Events
      87
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      35
      num Events
      15
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      36
      num Events
      18
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      96
      num Events
      9
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      97
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      35
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      96
      num Events
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      97
      num Events
      23
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      35
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      36
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      96
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Disseminated Intravascular Coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Haemorrhagic Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      97
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      97
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Splenic Haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      95
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      97
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Splenic Infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Splenomegaly
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      97
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      36
      num Events
      1
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      35
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute Coronary Syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      95
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      96
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      97
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute Left Ventricular Failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      95
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      96
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      97
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      35
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      36
      num Events
      0
    term
    Acute Myocardial Infarction
time Frame
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Up to 92 Weeks) regardless of seriousness or relationship to investigational product.

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

Preserved source evidence · Independent clinical review pending · Not medical advice