Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00621244 · ADVERSE EVENTS

Adverse events

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies · Source last updated 2021-01-05

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
AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm1, Group X (20 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

8 / 88 / 8Not reported / Not reported
Arm1, Group X (30 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

5 / 88 / 8Not reported / Not reported
Arm1, Group X (40 mg)

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

9 / 1010 / 10Not reported / Not reported
Arm1 GroupX 60 mg

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

34 / 4949 / 49Not reported / Not reported
Arm1 GroupX 80 mg

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

10 / 1111 / 11Not reported / Not reported
Arm1 GroupY 20 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

0 / 11 / 1Not reported / Not reported
Arm1 GroupY 30 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

3 / 44 / 4Not reported / Not reported
Arm1 GroupY 40 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

10 / 2424 / 24Not reported / Not reported
Arm1 GroupY 60 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

2 / 55 / 5Not reported / Not reported
Arm2 GroupX 30 mg

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

5 / 66 / 6Not reported / Not reported
Arm2 GroupX 45 mg

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

8 / 99 / 9Not reported / Not reported
Arm2 GroupX 60 mg

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

7 / 99 / 9Not reported / Not reported
Arm2 GroupX 80 mg

Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.

8 / 99 / 9Not reported / Not reported
Arm2 GroupY 30 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

0 / 11 / 1Not reported / Not reported
Arm2 GroupY 45 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

3 / 77 / 7Not reported / Not reported
Arm2 GroupY 60 mg

Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

11 / 1515 / 15Not reported / Not reported

Group identifiers: EG000: Arm1, Group X (20 mg) · EG001: Arm1, Group X (30 mg) · EG002: Arm1, Group X (40 mg) · EG003: Arm1 GroupX 60 mg · EG004: Arm1 GroupX 80 mg · EG005: Arm1 GroupY 20 mg · EG006: Arm1 GroupY 30 mg · EG007: Arm1 GroupY 40 mg · EG008: Arm1 GroupY 60 mg · EG009: Arm2 GroupX 30 mg · EG010: Arm2 GroupX 45 mg · EG011: Arm2 GroupX 60 mg · EG012: Arm2 GroupX 80 mg · EG013: Arm2 GroupY 30 mg · EG014: Arm2 GroupY 45 mg · EG015: Arm2 GroupY 60 mg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      9
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Sinus tachycardia

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
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Coagulopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Hypoprothrombinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      9
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      9
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      9
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Splenic infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Splenomegaly
Complete source fields
event Groups
  1. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    8
    serious Num At Risk
    8
    title
    Arm1, Group X (20 mg)
  2. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    5
    serious Num At Risk
    8
    title
    Arm1, Group X (30 mg)
  3. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    9
    serious Num At Risk
    10
    title
    Arm1, Group X (40 mg)
  4. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG003
    other Num Affected
    49
    other Num At Risk
    49
    serious Num Affected
    34
    serious Num At Risk
    49
    title
    Arm1 GroupX 60 mg
  5. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    10
    serious Num At Risk
    11
    title
    Arm1 GroupX 80 mg
  6. description
    Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    EG005
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Arm1 GroupY 20 mg
  7. description
    Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Arm1 GroupY 30 mg
  8. description
    Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    EG007
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    10
    serious Num At Risk
    24
    title
    Arm1 GroupY 40 mg
  9. description
    Panobinostat was administered orally, once-a-day, on Monday- Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Arm1 GroupY 60 mg
  10. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG009
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    5
    serious Num At Risk
    6
    title
    Arm2 GroupX 30 mg
  11. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG010
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    8
    serious Num At Risk
    9
    title
    Arm2 GroupX 45 mg
  12. description
    Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), as part of a 28-day treatment cycle. Group X is a sub-arm, based on disease indication.
    id
    EG011
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    7
    serious Num At Risk
    9
    title
    Arm2 GroupX 60 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Coagulopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Hypoprothrombinaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      9
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      9
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      9
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Splenic infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Splenomegaly
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      9
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      49
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      24
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      9
    term
    Sinus tachycardia
time Frame
AEs were collected for at least 4 weeks following last dose of treatment (3.5 years)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice