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NCT02555657 · ADVERSE EVENTS

Adverse events

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) · Source last updated 2021-12-10

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
All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 60 months
Other-event reporting threshold
5%

All-cause mortality table includes all randomized participants. Serious and other AEs include participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for all-cause mortality and AEs separately.

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

Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to \~2 years).

65 / 309259 / 309283 / 312
Chemotherapy

Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.

60 / 292263 / 292289 / 310
Pembrolizumab Second Course

Qualified participants who received the first course of pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to \~2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).

1 / 84 / 80 / 8

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      309
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      292
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      292
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      292
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      309
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      292
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      309
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      292
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      309
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cardiogenic shock
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Secondary adrenocortical insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      309
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      292
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Colitis

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      309
      num Events
      31
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      292
      num Events
      80
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      309
      num Events
      2
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      292
      num Events
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      309
      num Events
      26
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      292
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      309
      num Events
      18
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      292
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      309
      num Events
      56
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      292
      num Events
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      309
      num Events
      34
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      292
      num Events
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      309
      num Events
      63
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      292
      num Events
      117
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      309
      num Events
      7
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      292
      num Events
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      309
      num Events
      30
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      292
      num Events
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      309
      num Events
      40
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      292
      num Events
      42
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      309
      num Events
      67
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      292
      num Events
      61
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      309
      num Events
      9
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      292
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Malaise
Complete source fields
description
All-cause mortality table includes all randomized participants. Serious and other AEs include participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Participants who received a second course of pembrolizumab per protocol were monitored for all-cause mortality and AEs separately.
event Groups
  1. deaths Num Affected
    283
    deaths Num At Risk
    312
    description
    Participants received pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to \~2 years).
    id
    EG000
    other Num Affected
    259
    other Num At Risk
    309
    serious Num Affected
    65
    serious Num At Risk
    309
    title
    Pembrolizumab First Course
  2. deaths Num Affected
    289
    deaths Num At Risk
    310
    description
    Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as TPC in accordance with local regulations and guidelines.
    id
    EG001
    other Num Affected
    263
    other Num At Risk
    292
    serious Num Affected
    60
    serious Num At Risk
    292
    title
    Chemotherapy
  3. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    Qualified participants who received the first course of pembrolizumab 200 mg IV Q3W for up to 35 administrations (up to \~2 years), but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 17 administrations (up to \~1 year).
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    Pembrolizumab Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      309
      num Events
      31
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      292
      num Events
      80
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      309
      num Events
      2
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      292
      num Events
      146
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      309
      num Events
      26
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      292
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      309
      num Events
      18
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      292
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      309
      num Events
      56
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      292
      num Events
      59
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      309
      num Events
      34
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      292
      num Events
      83
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      309
      num Events
      63
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      292
      num Events
      117
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      309
      num Events
      7
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      292
      num Events
      24
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      309
      num Events
      30
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      292
      num Events
      44
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      309
      num Events
      40
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      292
      num Events
      42
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      309
      num Events
      67
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      292
      num Events
      61
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      309
      num Events
      9
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      292
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Malaise
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      309
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      292
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      292
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      292
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      309
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      292
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      309
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      292
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      309
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cardio-respiratory arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Cardiogenic shock
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Secondary adrenocortical insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      309
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      309
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      292
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Colitis
time Frame
All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 60 months

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