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NCT03219333 · ADVERSE EVENTS

Adverse events

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer · Source last updated 2024-08-27

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
Cohort 1: maximum up to 62.36 months of follow-up; Cohort 2: maximum up to 48.95 months of follow-up
Other-event reporting threshold
5%

Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enfortumab Vedotin - Cohort 1

Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

59 / 125123 / 125104 / 125
Enfortumab Vedotin - Cohort 2

Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

35 / 8988 / 8972 / 89

Group identifiers: EG000: Enfortumab Vedotin - Cohort 1 · EG001: Enfortumab Vedotin - Cohort 2

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
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Bacteraemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      125
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      89
      num Events
      2
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      89
      num Events
      2
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Atrial thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
      num Events
      0
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Adrenal insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Abdominal pain

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 v26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      125
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      89
      num Events
      12
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
      num Events
      11
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      89
      num Events
      5
    term
    Hypophosphataemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      125
      num Events
      62
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      89
      num Events
      42
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      89
      num Events
      7
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      125
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      89
      num Events
      3
    term
    Blepharitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      125
      num Events
      32
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      89
      num Events
      19
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      125
      num Events
      25
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      89
      num Events
      14
    term
    Lacrimation increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      125
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      89
      num Events
      3
    term
    Punctate keratitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      125
      num Events
      25
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      89
      num Events
      10
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      89
      num Events
      8
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      125
      num Events
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      89
      num Events
      8
    term
    Abdominal pain
Complete source fields
description
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
event Groups
  1. deaths Num Affected
    104
    deaths Num At Risk
    125
    description
    Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    EG000
    other Num Affected
    123
    other Num At Risk
    125
    serious Num Affected
    59
    serious Num At Risk
    125
    title
    Enfortumab Vedotin - Cohort 1
  2. deaths Num Affected
    72
    deaths Num At Risk
    89
    description
    Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    EG001
    other Num Affected
    88
    other Num At Risk
    89
    serious Num Affected
    35
    serious Num At Risk
    89
    title
    Enfortumab Vedotin - Cohort 2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      125
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      89
      num Events
      12
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
      num Events
      11
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      89
      num Events
      5
    term
    Hypophosphataemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      125
      num Events
      62
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      89
      num Events
      42
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      89
      num Events
      7
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      125
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      89
      num Events
      3
    term
    Blepharitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      125
      num Events
      32
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      89
      num Events
      19
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      125
      num Events
      25
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      89
      num Events
      14
    term
    Lacrimation increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      125
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      89
      num Events
      3
    term
    Punctate keratitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      125
      num Events
      25
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      89
      num Events
      10
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
      num Events
      4
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      89
      num Events
      8
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      125
      num Events
      26
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      89
      num Events
      8
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Bacteraemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      125
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      89
      num Events
      2
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      89
      num Events
      2
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Atrial thrombosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      89
      num Events
      0
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Adrenal insufficiency
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Cataract
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      89
      num Events
      1
    term
    Abdominal pain
time Frame
Cohort 1: maximum up to 62.36 months of follow-up; Cohort 2: maximum up to 48.95 months of follow-up

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