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NCT04656652 · ADVERSE EVENTS

Adverse events

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) · Source last updated 2026-08-26

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 28 days after last dose of the study drug, up 43 months.
Other-event reporting threshold
5%

A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DS-1062a 6.0 mg/kg

Participants were randomized to receive 6.0 mg/kg of DS-1062a.

92 / 297273 / 297215 / 299
Docetaxel 75 mg/m^2

Participants were randomized to receive 75 mg/m\^2 docetaxel.

111 / 290262 / 290218 / 305

Group identifiers: EG000: DS-1062a 6.0 mg/kg · EG001: Docetaxel 75 mg/m^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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      297
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      290
      num Events
      11
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      297
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      290
      num Events
      4
    term
    Myelosuppression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
      num Events
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Coronary artery stenosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Pericardial effusion

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
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      297
      num Events
      90
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      290
      num Events
      140
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      297
      num Events
      7
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      290
      num Events
      32
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      297
      num Events
      7
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      290
      num Events
      66
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      297
      num Events
      23
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      290
      num Events
      3
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      297
      num Events
      23
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      290
      num Events
      17
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      297
      num Events
      70
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      290
      num Events
      47
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      297
      num Events
      54
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      290
      num Events
      90
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      297
      num Events
      20
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      290
      num Events
      9
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      297
      num Events
      166
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      290
      num Events
      74
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      297
      num Events
      279
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      290
      num Events
      65
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      297
      num Events
      65
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      290
      num Events
      37
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      297
      num Events
      139
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      290
      num Events
      107
    term
    Asthenia
Complete source fields
description
A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
event Groups
  1. deaths Num Affected
    215
    deaths Num At Risk
    299
    description
    Participants were randomized to receive 6.0 mg/kg of DS-1062a.
    id
    EG000
    other Num Affected
    273
    other Num At Risk
    297
    serious Num Affected
    92
    serious Num At Risk
    297
    title
    DS-1062a 6.0 mg/kg
  2. deaths Num Affected
    218
    deaths Num At Risk
    305
    description
    Participants were randomized to receive 75 mg/m\^2 docetaxel.
    id
    EG001
    other Num Affected
    262
    other Num At Risk
    290
    serious Num Affected
    111
    serious Num At Risk
    290
    title
    Docetaxel 75 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      297
      num Events
      90
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      290
      num Events
      140
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      297
      num Events
      7
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      290
      num Events
      32
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      297
      num Events
      7
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      290
      num Events
      66
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      297
      num Events
      23
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      290
      num Events
      3
    term
    Dry eye
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      297
      num Events
      23
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      290
      num Events
      17
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      297
      num Events
      70
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      290
      num Events
      47
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      297
      num Events
      54
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      290
      num Events
      90
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      297
      num Events
      20
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      290
      num Events
      9
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      297
      num Events
      166
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      290
      num Events
      74
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      297
      num Events
      279
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      290
      num Events
      65
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      297
      num Events
      65
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      290
      num Events
      37
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      297
      num Events
      139
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      290
      num Events
      107
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      297
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      290
      num Events
      11
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      297
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      290
      num Events
      4
    term
    Myelosuppression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      290
      num Events
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      297
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Cardio-respiratory arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Coronary artery stenosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Palpitations
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      297
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      290
      num Events
      0
    term
    Pericardial effusion
time Frame
Adverse events (AE) were collected from the date of signing the informed consent form up to 28 days after last dose of the study drug, up 43 months.

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