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NCT02564263 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181) · Source last updated 2023-03-13

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
Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)
Other-event reporting threshold
5%

All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab First Course

Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).

127 / 314285 / 314305 / 314
Chemotherapy

Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).

121 / 296281 / 296305 / 314
Pembrolizumab Second Course

Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

1 / 55 / 53 / 5

Group identifiers: EG000: Pembrolizumab First Course · EG001: Chemotherapy · 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
      2
      num At Risk
      314
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      296
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      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
      1
      num At Risk
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      296
      num Events
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      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
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      296
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute left ventricular failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      314
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      296
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardio-respiratory arrest
  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
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Myocarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinus tachycardia
  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
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tachycardia

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      314
      num Events
      60
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      296
      num Events
      110
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      2
    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
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      296
      num Events
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      314
      num Events
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      296
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      314
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      296
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      314
      num Events
      36
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      296
      num Events
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      314
      num Events
      16
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      296
      num Events
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      314
      num Events
      63
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      296
      num Events
      63
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      314
      num Events
      65
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      296
      num Events
      120
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      314
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      296
      num Events
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      314
      num Events
      44
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      296
      num Events
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      314
      num Events
      66
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      296
      num Events
      110
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      314
      num Events
      9
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      296
      num Events
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Stomatitis
Complete source fields
description
All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
event Groups
  1. deaths Num Affected
    305
    deaths Num At Risk
    314
    description
    Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
    id
    EG000
    other Num Affected
    285
    other Num At Risk
    314
    serious Num Affected
    127
    serious Num At Risk
    314
    title
    Pembrolizumab First Course
  2. deaths Num Affected
    305
    deaths Num At Risk
    314
    description
    Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
    id
    EG001
    other Num Affected
    281
    other Num At Risk
    296
    serious Num Affected
    121
    serious Num At Risk
    296
    title
    Chemotherapy
  3. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    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
      52
      num At Risk
      314
      num Events
      60
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      296
      num Events
      110
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      2
    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
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      296
      num Events
      65
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      314
      num Events
      40
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      296
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      314
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      296
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal distension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      314
      num Events
      36
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      296
      num Events
      32
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      314
      num Events
      16
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      296
      num Events
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      314
      num Events
      63
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      296
      num Events
      63
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      314
      num Events
      65
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      296
      num Events
      120
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      314
      num Events
      7
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      296
      num Events
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Dyspepsia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      314
      num Events
      44
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      296
      num Events
      27
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      314
      num Events
      66
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      296
      num Events
      110
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      314
      num Events
      9
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      296
      num Events
      30
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Stomatitis
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
      2
      num At Risk
      314
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      296
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      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
      1
      num At Risk
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      296
      num Events
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      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
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Immune thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      296
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute left ventricular failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      314
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      296
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardio-respiratory arrest
  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
      314
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      296
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Myocarditis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sinus tachycardia
  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
      314
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      296
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tachycardia
time Frame
Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)

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Preserved source evidence · Not medical advice