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NCT02180724 · ADVERSE EVENTS

Adverse events

An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia · Source last updated 2026-06-16

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
Reported Adverse Events (AEs) include events from the first dose of study drug until 30 days after the last dose of the study drug or start of a new anti-cancer therapy (whichever came first), assessed up to approximately 6 years and 7 months.
Other-event reporting threshold
0%

In original protocol, subjects were planned to be randomized 1:1 into 2 cohorts: Acala 100 mg BIDx28 days and 200 mg QDx28 days respectively. After enrollment started, 6 pts received Acala 200 mg QD (5 pts previously treated,1 pt treatment naïve).Per safety and occupancy data in CLL pts, a protocol amendment was made on 13MAR2015, and the 6 pts on 200 mg QD were switched to 100 BID for the remainder of the study. Median 200 mg QD exposure prior to switch was 6.9 \[range: 2.4-13.8\] months.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Previously Treated (PT) Cohort 1

PT 100 mg BID (n = 87)

56 / 8787 / 8726 / 87
Previously Treated (PT) Cohort 2

PT 200 mg QD (n = 5)

3 / 55 / 50 / 5
Previously Treated (PT) Total

PT 100 mg BID + 200 mg QD (N = 92)

59 / 9292 / 9226 / 92
Treatment Naive (TN) Cohort 1

TN 100 mg BID (N = 13)

9 / 1313 / 131 / 13
Treatment Naive (TN) Cohort 2

TN 200 mg QD (n = 1)

0 / 11 / 10 / 1
Treatment Naive (TN) Total

TN 100 mg BID + 200 mg QD (n = 14)

9 / 1414 / 141 / 14

Group identifiers: EG000: Previously Treated (PT) Cohort 1 · EG001: Previously Treated (PT) Cohort 2 · EG002: Previously Treated (PT) Total · EG003: Treatment Naive (TN) Cohort 1 · EG004: Treatment Naive (TN) Cohort 2 · EG005: Treatment Naive (TN) Total

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 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      92
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      87
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      92
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      87
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      92
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      87
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      92
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Coronary artery disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      87
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      92
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Nodal arrhythmia

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 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      87
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      92
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cold type haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      87
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      92
      num Events
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Increased tendency to bruise
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      92
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Microcytic anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      87
      num Events
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      92
      num Events
      50
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      87
      num Events
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      92
      num Events
      23
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Thymic cyst
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      92
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Acute coronary syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      2
    term
    Angina pectoris
Complete source fields
description
In original protocol, subjects were planned to be randomized 1:1 into 2 cohorts: Acala 100 mg BIDx28 days and 200 mg QDx28 days respectively. After enrollment started, 6 pts received Acala 200 mg QD (5 pts previously treated,1 pt treatment naïve).Per safety and occupancy data in CLL pts, a protocol amendment was made on 13MAR2015, and the 6 pts on 200 mg QD were switched to 100 BID for the remainder of the study. Median 200 mg QD exposure prior to switch was 6.9 \[range: 2.4-13.8\] months.
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    87
    description
    PT 100 mg BID (n = 87)
    id
    EG000
    other Num Affected
    87
    other Num At Risk
    87
    serious Num Affected
    56
    serious Num At Risk
    87
    title
    Previously Treated (PT) Cohort 1
  2. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    PT 200 mg QD (n = 5)
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Previously Treated (PT) Cohort 2
  3. deaths Num Affected
    26
    deaths Num At Risk
    92
    description
    PT 100 mg BID + 200 mg QD (N = 92)
    id
    EG002
    other Num Affected
    92
    other Num At Risk
    92
    serious Num Affected
    59
    serious Num At Risk
    92
    title
    Previously Treated (PT) Total
  4. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    TN 100 mg BID (N = 13)
    id
    EG003
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    9
    serious Num At Risk
    13
    title
    Treatment Naive (TN) Cohort 1
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    TN 200 mg QD (n = 1)
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Treatment Naive (TN) Cohort 2
  6. deaths Num Affected
    1
    deaths Num At Risk
    14
    description
    TN 100 mg BID + 200 mg QD (n = 14)
    id
    EG005
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    9
    serious Num At Risk
    14
    title
    Treatment Naive (TN) Total
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      87
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      92
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cold type haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      87
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      92
      num Events
      11
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Increased tendency to bruise
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      92
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphadenopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Microcytic anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      87
      num Events
      50
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      92
      num Events
      50
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      87
      num Events
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      92
      num Events
      23
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Thymic cyst
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      92
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Acute coronary syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      2
    term
    Angina pectoris
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      87
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      92
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Angina pectoris
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      87
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      92
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      87
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      92
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      87
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      92
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Coronary artery disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      87
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      92
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Myocardial ischaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      87
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      92
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Nodal arrhythmia
time Frame
Reported Adverse Events (AEs) include events from the first dose of study drug until 30 days after the last dose of the study drug or start of a new anti-cancer therapy (whichever came first), assessed up to approximately 6 years and 7 months.

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