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NCT05113251 · ADVERSE EVENTS

Adverse events

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer · Source last updated 2026-08-11

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: from date of randomization through to death due to any cause. Adverse events and SAEs are reported from the first dose date, throughout the treatment period and the safety follow-up period (until 40 + 7 days after the discontinuation of all study interventions). Both up to a maximum of approximately 40 months to primary pCR DCO (12MAR2025).
Other-event reporting threshold
5%

All-cause mortality was reported for all randomized subjects regardless of treatment received. Adverse events are reported for participants who received at least 1 dose of study drug (T-DXd, paclitaxel, trastuzumab, pertuzumab, doxorubicin, and cyclophosphamide) and are summarized according to the treatment arm they were randomised to. This is to provide a summary of the underlying safety profile that patients should expect when initially prescribed treatment.

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

Description (Arm-group)

29 / 283269 / 2838 / 286
T-DXd-THP

Description (Arm-group)

34 / 320306 / 3203 / 321
ddAC-THP

Description (Arm-group)

63 / 312307 / 3129 / 320

Group identifiers: EG000: T-DXd · EG001: T-DXd-THP · EG002: ddAC-THP

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
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      283
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      312
      num Events
      2
    term
    Interstitial lung disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Pleural effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      320
      num Events
      4
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      312
      num Events
      7
    term
    Pneumonitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Productive cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      283
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      320
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      312
      num Events
      0
    term
    Pulmonary embolism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      320
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      312
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Rash maculo-papular
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Embolism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      312
      num Events
      2
    term
    Jugular vein thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      312
      num Events
      0
    term
    Vertigo positional
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Subclavian vein thrombosis

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      283
      num Events
      32
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      320
      num Events
      38
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      312
      num Events
      49
    term
    Cough
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      283
      num Events
      11
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      320
      num Events
      22
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      312
      num Events
      16
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      283
      num Events
      19
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      320
      num Events
      60
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      312
      num Events
      43
    term
    Epistaxis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      283
      num Events
      13
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      320
      num Events
      19
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      312
      num Events
      20
    term
    Oropharyngeal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      283
      num Events
      120
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      320
      num Events
      159
    3. group Id
      EG002
      num Affected
      153
      num At Risk
      312
      num Events
      163
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      283
      num Events
      8
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      320
      num Events
      13
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      312
      num Events
      32
    term
    Dry skin
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      320
      num Events
      2
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      312
      num Events
      18
    term
    Nail discolouration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      283
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      320
      num Events
      7
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      312
      num Events
      25
    term
    Nail disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      320
      num Events
      6
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      312
      num Events
      17
    term
    Palmar-plantar erythrodysaesthesia syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      283
      num Events
      3
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      320
      num Events
      21
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      312
      num Events
      12
    term
    Pruritus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      283
      num Events
      13
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      320
      num Events
      59
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      312
      num Events
      41
    term
    Rash
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      283
      num Events
      16
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      320
      num Events
      29
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      312
      num Events
      28
    term
    Hot flush
Complete source fields
description
All-cause mortality was reported for all randomized subjects regardless of treatment received. Adverse events are reported for participants who received at least 1 dose of study drug (T-DXd, paclitaxel, trastuzumab, pertuzumab, doxorubicin, and cyclophosphamide) and are summarized according to the treatment arm they were randomised to. This is to provide a summary of the underlying safety profile that patients should expect when initially prescribed treatment.
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    286
    description
    Description (Arm-group)
    id
    EG000
    other Num Affected
    269
    other Num At Risk
    283
    serious Num Affected
    29
    serious Num At Risk
    283
    title
    T-DXd
  2. deaths Num Affected
    3
    deaths Num At Risk
    321
    description
    Description (Arm-group)
    id
    EG001
    other Num Affected
    306
    other Num At Risk
    320
    serious Num Affected
    34
    serious Num At Risk
    320
    title
    T-DXd-THP
  3. deaths Num Affected
    9
    deaths Num At Risk
    320
    description
    Description (Arm-group)
    id
    EG002
    other Num Affected
    307
    other Num At Risk
    312
    serious Num Affected
    63
    serious Num At Risk
    312
    title
    ddAC-THP
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      283
      num Events
      32
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      320
      num Events
      38
    3. group Id
      EG002
      num Affected
      45
      num At Risk
      312
      num Events
      49
    term
    Cough
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      283
      num Events
      11
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      320
      num Events
      22
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      312
      num Events
      16
    term
    Dyspnoea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      283
      num Events
      19
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      320
      num Events
      60
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      312
      num Events
      43
    term
    Epistaxis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      283
      num Events
      13
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      320
      num Events
      19
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      312
      num Events
      20
    term
    Oropharyngeal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      283
      num Events
      120
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      320
      num Events
      159
    3. group Id
      EG002
      num Affected
      153
      num At Risk
      312
      num Events
      163
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      283
      num Events
      8
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      320
      num Events
      13
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      312
      num Events
      32
    term
    Dry skin
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      320
      num Events
      2
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      312
      num Events
      18
    term
    Nail discolouration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      283
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      320
      num Events
      7
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      312
      num Events
      25
    term
    Nail disorder
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      320
      num Events
      6
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      312
      num Events
      17
    term
    Palmar-plantar erythrodysaesthesia syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      283
      num Events
      3
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      320
      num Events
      21
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      312
      num Events
      12
    term
    Pruritus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      283
      num Events
      13
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      320
      num Events
      59
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      312
      num Events
      41
    term
    Rash
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      283
      num Events
      16
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      320
      num Events
      29
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      312
      num Events
      28
    term
    Hot flush
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      283
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      312
      num Events
      2
    term
    Interstitial lung disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Pleural effusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      320
      num Events
      4
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      312
      num Events
      7
    term
    Pneumonitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Productive cough
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      283
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      320
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      312
      num Events
      0
    term
    Pulmonary embolism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      320
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      312
      num Events
      0
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Rash maculo-papular
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Embolism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      312
      num Events
      2
    term
    Jugular vein thrombosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      283
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      312
      num Events
      0
    term
    Vertigo positional
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      283
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      320
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      312
      num Events
      1
    term
    Subclavian vein thrombosis
time Frame
All-cause mortality: from date of randomization through to death due to any cause. Adverse events and SAEs are reported from the first dose date, throughout the treatment period and the safety follow-up period (until 40 + 7 days after the discontinuation of all study interventions). Both up to a maximum of approximately 40 months to primary pCR DCO (12MAR2025).

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Preserved source evidence · Not medical advice