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NCT04744831 · ADVERSE EVENTS

Adverse events

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer · Source last updated 2026-01-14

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
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 44 months. For Final Results, data was collected up until 04 Dec 2024.
Other-event reporting threshold
5%

Safety parameters were collected, analyzed, and reported based on the dosage of treatment drug administered as specified in the study protocol, therefore as 2 arms, T-DXd 5.4 mg/kg Q3W and T-DXd 6.4 mg/kg Q3W.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
T-DXd 5.4 mg/kg Q3W

Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

21 / 8381 / 8326 / 83
T-DXd 6.4 mg/kg Q3W

Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

12 / 3938 / 3913 / 39

Group identifiers: EG000: T-DXd 5.4 mg/kg Q3W · EG001: T-DXd 6.4 mg/kg Q3W

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
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Gastrointestinal perforation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Ileus paralytic
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      2
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Gastritis

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
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      83
      num Events
      52
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      39
      num Events
      43
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      83
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Retinal haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      83
      num Events
      102
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      39
      num Events
      36
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      83
      num Events
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      39
      num Events
      8
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      83
      num Events
      38
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      39
      num Events
      14
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
      num Events
      29
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      83
      num Events
      17
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      39
      num Events
      13
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      83
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      4
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
      num Events
      31
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      39
      num Events
      20
    term
    Asthenia
Complete source fields
description
Safety parameters were collected, analyzed, and reported based on the dosage of treatment drug administered as specified in the study protocol, therefore as 2 arms, T-DXd 5.4 mg/kg Q3W and T-DXd 6.4 mg/kg Q3W.
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    83
    description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    EG000
    other Num Affected
    81
    other Num At Risk
    83
    serious Num Affected
    21
    serious Num At Risk
    83
    title
    T-DXd 5.4 mg/kg Q3W
  2. deaths Num Affected
    13
    deaths Num At Risk
    39
    description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
    id
    EG001
    other Num Affected
    38
    other Num At Risk
    39
    serious Num Affected
    12
    serious Num At Risk
    39
    title
    T-DXd 6.4 mg/kg Q3W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      83
      num Events
      52
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      39
      num Events
      43
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      83
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      6
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      83
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Retinal haemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      83
      num Events
      102
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      39
      num Events
      36
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      83
      num Events
      20
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      39
      num Events
      8
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      83
      num Events
      38
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      39
      num Events
      14
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
      num Events
      29
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      83
      num Events
      17
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      39
      num Events
      13
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      83
      num Events
      9
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      4
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      83
      num Events
      31
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      39
      num Events
      20
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      83
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Gastrointestinal perforation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      83
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Ileus paralytic
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      2
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      83
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Gastritis
time Frame
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up to approximately 44 months. For Final Results, data was collected up until 04 Dec 2024.

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Preserved source evidence · Independent clinical review pending · Not medical advice