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NCT02784171 · ADVERSE EVENTS

Adverse events

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma · Source last updated 2024-12-10

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

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

Collection time frame
Adverse events were monitored continuously throughout the study and during follow-up. Patients were evaluated before each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A - Cisplatin/Pemetrexed (Phase II)

Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed

8 / 2120 / 2121 / 21
Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)

Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab

10 / 1918 / 1914 / 19
Arm C - Pembrolizumab (Phase II Only)

Pembrolizumab 200 mg\* IV 30 min Day 1 every 21 days for a total of 2 years Pembrolizumab

13 / 4038 / 4038 / 40
Arm A - Cisplatin/Pemetrexed (Phase III)

Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed

38 / 218200 / 218175 / 218
Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)

Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles

92 / 222217 / 222167 / 222

Group identifiers: EG000: Arm A - Cisplatin/Pemetrexed (Phase II) · EG001: Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II) · EG002: Arm C - Pembrolizumab (Phase II Only) · EG003: Arm A - Cisplatin/Pemetrexed (Phase III) · EG004: Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      222
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Bone marrow hypocellular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      222
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      222
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Cardiac disorders - Other specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Pericarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Supraventricular 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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Blood and lymphatic system disorders - Other specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      222
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Atrioventricular block first degree
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Cardiac disorders - Other specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Chest pain - cardiac
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      222
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Paroxysmal atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Sinus tachycardia
Complete source fields
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    21
    description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    EG000
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    8
    serious Num At Risk
    21
    title
    Arm A - Cisplatin/Pemetrexed (Phase II)
  2. deaths Num Affected
    14
    deaths Num At Risk
    19
    description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    19
    serious Num Affected
    10
    serious Num At Risk
    19
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)
  3. deaths Num Affected
    38
    deaths Num At Risk
    40
    description
    Pembrolizumab 200 mg\* IV 30 min Day 1 every 21 days for a total of 2 years Pembrolizumab
    id
    EG002
    other Num Affected
    38
    other Num At Risk
    40
    serious Num Affected
    13
    serious Num At Risk
    40
    title
    Arm C - Pembrolizumab (Phase II Only)
  4. deaths Num Affected
    175
    deaths Num At Risk
    218
    description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    EG003
    other Num Affected
    200
    other Num At Risk
    218
    serious Num Affected
    38
    serious Num At Risk
    218
    title
    Arm A - Cisplatin/Pemetrexed (Phase III)
  5. deaths Num Affected
    167
    deaths Num At Risk
    222
    description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles
    id
    EG004
    other Num Affected
    217
    other Num At Risk
    222
    serious Num Affected
    92
    serious Num At Risk
    222
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Blood and lymphatic system disorders - Other specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      222
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Atrial flutter
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Atrioventricular block first degree
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Cardiac disorders - Other specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Chest pain - cardiac
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      222
    term
    Palpitations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Paroxysmal atrial tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Sinus bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Sinus tachycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      222
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Bone marrow hypocellular
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      222
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      222
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Cardiac disorders - Other specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      222
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      222
    term
    Pericardial effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Pericarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      40
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      218
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      222
    term
    Supraventricular tachycardia
time Frame
Adverse events were monitored continuously throughout the study and during follow-up. Patients were evaluated before each cycle, 4 weeks after discontinuation, every 12 weeks until progression, and then every 24 weeks until death, an average of 16.2 months.

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