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NCT03553836 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716) · Source last updated 2024-11-29

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 (ACM) : Up to ~32.7 months and safety: Up to ~30.2 months
Other-event reporting threshold
5%

ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. ACM and Safety were analyzed separately in participants who switched over from placebo to pembrolizumab.

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

Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

101 / 483417 / 48317 / 487
Placebo

Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

91 / 486364 / 48618 / 489
Placebo Switched Over to Pembrolizumab

Participants who received the initial treatment of saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1 and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.

6 / 4526 / 453 / 45

Group identifiers: EG000: Pembrolizumab · EG001: Placebo · EG002: Placebo Switched Over to Pembrolizumab

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Lymphadenopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      486
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      483
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Autoimmune myocarditis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      486
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Coronary artery disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Mitral valve incompetence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      483
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Adrenal insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Endocrine disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Hypophysitis

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
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      483
      num Events
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      486
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      45
      num Events
      4
    term
    Hyperthyroidism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      483
      num Events
      82
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      486
      num Events
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      483
      num Events
      37
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      486
      num Events
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      3
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      483
      num Events
      46
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      486
      num Events
      45
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      134
      num At Risk
      483
      num Events
      222
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      486
      num Events
      176
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
      num Events
      33
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      486
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      483
      num Events
      100
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      486
      num Events
      90
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
      num Events
      40
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      486
      num Events
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      483
      num Events
      75
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      486
      num Events
      80
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      140
      num At Risk
      483
      num Events
      161
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      486
      num Events
      137
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      483
      num Events
      35
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      486
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
      num Events
      32
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      486
      num Events
      26
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Pyrexia
Complete source fields
description
ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs. ACM and Safety were analyzed separately in participants who switched over from placebo to pembrolizumab.
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    487
    description
    Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    EG000
    other Num Affected
    417
    other Num At Risk
    483
    serious Num Affected
    101
    serious Num At Risk
    483
    title
    Pembrolizumab
  2. deaths Num Affected
    18
    deaths Num At Risk
    489
    description
    Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    EG001
    other Num Affected
    364
    other Num At Risk
    486
    serious Num Affected
    91
    serious Num At Risk
    486
    title
    Placebo
  3. deaths Num Affected
    3
    deaths Num At Risk
    45
    description
    Participants who received the initial treatment of saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1 and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    EG002
    other Num Affected
    26
    other Num At Risk
    45
    serious Num Affected
    6
    serious Num At Risk
    45
    title
    Placebo Switched Over to Pembrolizumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      483
      num Events
      50
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      486
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      45
      num Events
      4
    term
    Hyperthyroidism
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      483
      num Events
      82
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      486
      num Events
      16
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      483
      num Events
      37
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      486
      num Events
      29
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      3
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      483
      num Events
      46
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      486
      num Events
      45
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      134
      num At Risk
      483
      num Events
      222
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      486
      num Events
      176
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
      num Events
      33
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      486
      num Events
      10
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      483
      num Events
      100
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      486
      num Events
      90
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
      num Events
      40
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      486
      num Events
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      483
      num Events
      75
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      486
      num Events
      80
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      140
      num At Risk
      483
      num Events
      161
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      486
      num Events
      137
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      483
      num Events
      35
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      486
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      483
      num Events
      32
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      486
      num Events
      26
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Lymphadenopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      486
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Acute myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      483
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Autoimmune myocarditis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Cardiomyopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      486
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Coronary artery disease
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Mitral valve incompetence
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      483
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      486
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      483
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Adrenal insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      483
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Endocrine disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      483
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      486
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Hypophysitis
time Frame
All-cause mortality (ACM) : Up to ~32.7 months and safety: Up to ~30.2 months

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Preserved source evidence · Not medical advice