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NCT03066778 · ADVERSE EVENTS

Adverse events

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604) · Source last updated 2022-10-03

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
First Course: Up to 49.5 months Second Course: Up to 37.9 months First and second course dosing occurred concurrently
Other-event reporting threshold
5%

All-cause mortality (ACM)=all randomized participants; AE=all participants who received ≥1 dose of study treatment. Per protocol, MedDRA preferred terms neoplasm progression (NP), malignant NP, disease progression not related to study treatment are excluded. ACM was adjusted for the participant who was randomized to pembrolizumab+EP and treated with placebo+EP. AEs presented by actual treatment received. Per protocol, collection of AE and ACM were planned for first and second courses.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab+EP

During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.

111 / 223221 / 223196 / 227
Placebo+EP

During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).

89 / 223216 / 223212 / 226
Pembrolizumab Second Course

Participants who met the criteria for retreatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle for up to 1 year of treatment.

1 / 11 / 11 / 1

Group identifiers: EG000: Pembrolizumab+EP · EG001: Placebo+EP · EG002: Pembrolizumab Second Course

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      223
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      223
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      223
      num Events
      15
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      223
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      223
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      223
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      223
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      223
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      223
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      223
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Myocarditis

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      223
      num Events
      122
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      223
      num Events
      115
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      223
      num Events
      84
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      223
      num Events
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      223
      num Events
      217
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      223
      num Events
      207
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      223
      num Events
      85
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      223
      num Events
      80
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      223
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      223
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      223
      num Events
      27
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      223
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Inappropriate antidiuretic hormone secretion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      223
      num Events
      18
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      223
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      223
      num Events
      14
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      223
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      223
      num Events
      78
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      223
      num Events
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      223
      num Events
      67
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      223
      num Events
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      223
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      223
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dyspepsia
Complete source fields
description
All-cause mortality (ACM)=all randomized participants; AE=all participants who received ≥1 dose of study treatment. Per protocol, MedDRA preferred terms neoplasm progression (NP), malignant NP, disease progression not related to study treatment are excluded. ACM was adjusted for the participant who was randomized to pembrolizumab+EP and treated with placebo+EP. AEs presented by actual treatment received. Per protocol, collection of AE and ACM were planned for first and second courses.
event Groups
  1. deaths Num Affected
    196
    deaths Num At Risk
    227
    description
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    id
    EG000
    other Num Affected
    221
    other Num At Risk
    223
    serious Num Affected
    111
    serious Num At Risk
    223
    title
    Pembrolizumab+EP
  2. deaths Num Affected
    212
    deaths Num At Risk
    226
    description
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    id
    EG001
    other Num Affected
    216
    other Num At Risk
    223
    serious Num Affected
    89
    serious Num At Risk
    223
    title
    Placebo+EP
  3. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants who met the criteria for retreatment received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle for up to 1 year of treatment.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Pembrolizumab Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      223
      num Events
      122
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      223
      num Events
      115
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      223
      num Events
      84
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      223
      num Events
      70
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      223
      num Events
      217
    2. group Id
      EG001
      num Affected
      114
      num At Risk
      223
      num Events
      207
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      223
      num Events
      85
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      223
      num Events
      80
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      223
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      223
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      223
      num Events
      27
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      223
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    term
    Inappropriate antidiuretic hormone secretion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      223
      num Events
      18
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      223
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      223
      num Events
      14
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      223
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      223
      num Events
      78
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      223
      num Events
      69
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      223
      num Events
      67
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      223
      num Events
      48
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      223
      num Events
      13
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      223
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      223
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      223
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      223
      num Events
      15
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      223
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      223
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      223
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      223
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      223
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      223
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      223
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      223
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Cardiopulmonary failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      223
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      223
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      223
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Myocarditis
time Frame
First Course: Up to 49.5 months Second Course: Up to 37.9 months First and second course dosing occurred concurrently

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Preserved source evidence · Not medical advice