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NCT00946647 · ADVERSE EVENTS

Adverse events

A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). · Source last updated 2020-08-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.
Other-event reporting threshold
5%

Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase Ib PAN + 5-Aza 20mg

In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 g/m2/day for 7 days in Week 1 of each cycle

5 / 66 / 60 / 6
Phase Ib PAN + 5-Aza 30mg

In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle

15 / 1818 / 181 / 18
Phase Ib PAN + 5-Aza 40mg

In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle

6 / 77 / 72 / 7
Phase IIb PAN + 5-Aza

In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.

28 / 3838 / 386 / 38
Phase IIb 5-Aza

The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine: 75 mg/m\^2 subcutaneously daily from Day 1 to Day

28 / 4238 / 423 / 42
Phase Ib and IIb

Patients in the Panobinostat + 5-Azacytidine arm and in the 5-Azacytidine arm

82 / 111107 / 11112 / 111

Group identifiers: EG000: Phase Ib PAN + 5-Aza 20mg · EG001: Phase Ib PAN + 5-Aza 30mg · EG002: Phase Ib PAN + 5-Aza 40mg · EG003: Phase IIb PAN + 5-Aza · EG004: Phase IIb 5-Aza · EG005: Phase Ib and IIb

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 (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      27
      num At Risk
      111
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      111
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      111
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Atrial flutter

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 (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      40
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      111
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      111
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      39
      num At Risk
      111
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      111
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Splenomegaly
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      47
      num At Risk
      111
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Thrombocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Thrombotic microangiopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Angina pectoris
Complete source fields
description
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus the 28 days post treatment. 2 patients randomized to PAN+5AZA received only 5AZA \& no PAN \& were part of the safety set for 5AZA group. Also, 2 patients rand. to 5AZA did not receive any treatment \& were not part of the safety set but were part of the FAS for the 5AZA group
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    In this escalating phase, participants took panobinostat of 20 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 g/m2/day for 7 days in Week 1 of each cycle
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Phase Ib PAN + 5-Aza 20mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    18
    description
    In this escalating phase, participants took panobinostat of 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    15
    serious Num At Risk
    18
    title
    Phase Ib PAN + 5-Aza 30mg
  3. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    In this escalating phase, participants took panobinostat of 40 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15 and a fixed dose of 5-Azacytidine (5-Aza) at 75 mg/m2/day for 7 days in Week 1 of each cycle
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Phase Ib PAN + 5-Aza 40mg
  4. deaths Num Affected
    6
    deaths Num At Risk
    38
    description
    In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
    id
    EG003
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    28
    serious Num At Risk
    38
    title
    Phase IIb PAN + 5-Aza
  5. deaths Num Affected
    3
    deaths Num At Risk
    42
    description
    The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine: 75 mg/m\^2 subcutaneously daily from Day 1 to Day
    id
    EG004
    other Num Affected
    38
    other Num At Risk
    42
    serious Num Affected
    28
    serious Num At Risk
    42
    title
    Phase IIb 5-Aza
  6. deaths Num Affected
    12
    deaths Num At Risk
    111
    description
    Patients in the Panobinostat + 5-Azacytidine arm and in the 5-Azacytidine arm
    id
    EG005
    other Num Affected
    107
    other Num At Risk
    111
    serious Num Affected
    82
    serious Num At Risk
    111
    title
    Phase Ib and IIb
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      40
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      111
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      111
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      39
      num At Risk
      111
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      111
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Splenomegaly
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      47
      num At Risk
      111
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Thrombocytosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Thrombotic microangiopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Angina pectoris
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      27
      num At Risk
      111
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      111
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      111
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      111
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      111
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (21.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      38
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      42
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      111
    term
    Atrial flutter
time Frame
Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration 397.1 weeks.

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