Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04995419 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy · Source last updated 2025-10-07

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
Baseline up to 9.33 months
Other-event reporting threshold
5%

SAF

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enfortumab Vedotin 1.25 mg/kg

Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

18 / 4040 / 4010 / 40

Group identifiers: EG000: Enfortumab Vedotin 1.25 mg/kg

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 v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      5
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Intestinal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Febrile infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      6
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Alanine aminotransferase increased

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 v24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      40
      num Events
      81
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      6
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Eye discharge
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      5
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      40
      num Events
      25
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      40
      num Events
      31
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      10
    term
    Dyspepsia
Complete source fields
description
SAF
event Groups
  1. deaths Num Affected
    10
    deaths Num At Risk
    40
    description
    Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    18
    serious Num At Risk
    40
    title
    Enfortumab Vedotin 1.25 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      40
      num Events
      81
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      6
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
      num Events
      3
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Eye discharge
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      4
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      40
      num Events
      5
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      40
      num Events
      25
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      40
      num Events
      31
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      40
      num Events
      10
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
      num Events
      5
    term
    Leukopenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      2
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Intestinal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pyrexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Febrile infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      40
      num Events
      6
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Urinary tract infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Alanine aminotransferase increased
time Frame
Baseline up to 9.33 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice