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NCT03924895 · ADVERSE EVENTS

Adverse events

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) · Source last updated 2026-06-30

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
Up to approximately 69 months
Other-event reporting threshold
5%

All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Pembrolizumab + Surgery

Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.

107 / 163143 / 16376 / 166
Arm B: Surgery Alone

Participants receive standard of care surgery alone

94 / 24294 / 242111 / 259
Arm C: EV + Pembrolizumab + Surgery

Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.

97 / 167163 / 16738 / 170

Group identifiers: EG000: Arm A: Pembrolizumab + Surgery · EG001: Arm B: Surgery Alone · EG002: Arm C: EV + Pembrolizumab + Surgery

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 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      242
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      167
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      167
      num Events
      2
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Arteriosclerosis coronary artery
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      242
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
      num Events
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
      num Events
      1
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      242
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Cardiac failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Cardiac flutter

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 28.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      163
      num Events
      54
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      242
      num Events
      28
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      167
      num Events
      67
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      163
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      167
      num Events
      26
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      163
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      167
      num Events
      8
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      163
      num Events
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      167
      num Events
      26
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      167
      num Events
      10
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      167
      num Events
      18
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      163
      num Events
      12
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      242
      num Events
      16
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      167
      num Events
      18
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      163
      num Events
      27
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      242
      num Events
      20
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      167
      num Events
      53
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      163
      num Events
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      242
      num Events
      7
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      167
      num Events
      95
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      242
      num Events
      1
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      167
      num Events
      18
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      163
      num Events
      22
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      242
      num Events
      18
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      167
      num Events
      52
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      163
      num Events
      10
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      242
      num Events
      9
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      167
      num Events
      16
    term
    Vomiting
Complete source fields
description
All-cause mortality population includes all randomized participants. Serious and other adverse events (AEs) population includes all randomized participants who received at least one dose of study intervention, included in the arm reflecting actual treatment received. For Arm B participants, surgery is considered as study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
event Groups
  1. deaths Num Affected
    76
    deaths Num At Risk
    166
    description
    Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
    id
    EG000
    other Num Affected
    143
    other Num At Risk
    163
    serious Num Affected
    107
    serious Num At Risk
    163
    title
    Arm A: Pembrolizumab + Surgery
  2. deaths Num Affected
    111
    deaths Num At Risk
    259
    description
    Participants receive standard of care surgery alone
    id
    EG001
    other Num Affected
    94
    other Num At Risk
    242
    serious Num Affected
    94
    serious Num At Risk
    242
    title
    Arm B: Surgery Alone
  3. deaths Num Affected
    38
    deaths Num At Risk
    170
    description
    Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
    id
    EG002
    other Num Affected
    163
    other Num At Risk
    167
    serious Num Affected
    97
    serious Num At Risk
    167
    title
    Arm C: EV + Pembrolizumab + Surgery
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      163
      num Events
      54
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      242
      num Events
      28
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      167
      num Events
      67
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      163
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      167
      num Events
      26
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      163
      num Events
      20
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      167
      num Events
      8
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      163
      num Events
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      167
      num Events
      26
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      167
      num Events
      10
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      167
      num Events
      18
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      163
      num Events
      12
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      242
      num Events
      16
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      167
      num Events
      18
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      163
      num Events
      27
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      242
      num Events
      20
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      167
      num Events
      53
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      163
      num Events
      26
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      242
      num Events
      7
    3. group Id
      EG002
      num Affected
      54
      num At Risk
      167
      num Events
      95
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      163
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      242
      num Events
      1
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      167
      num Events
      18
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      163
      num Events
      22
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      242
      num Events
      18
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      167
      num Events
      52
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      163
      num Events
      10
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      242
      num Events
      9
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      167
      num Events
      16
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      242
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      167
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Leukocytosis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      163
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      167
      num Events
      2
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Arteriosclerosis coronary artery
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      242
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
      num Events
      1
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      167
      num Events
      1
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      242
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Cardiac failure acute
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      163
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Cardiac failure congestive
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      163
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      242
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      167
      num Events
      0
    term
    Cardiac flutter
time Frame
Up to approximately 69 months

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Preserved source evidence · Not medical advice