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NCT04685135 · ADVERSE EVENTS

Adverse events

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation · 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 and non serious adverse events were reported from first first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks). Serious adverse events were collected from date of signing of informed consent form till 28 days after last dose (Up to approximately 111 weeks).
Other-event reporting threshold
5%

The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Adagrasib

Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).

149 / 298292 / 298126 / 301
Docetaxel

Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.

50 / 140129 / 14053 / 152
Crossover Adagrasib

Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).

20 / 4443 / 4415 / 44

Group identifiers: EG000: Adagrasib · EG001: Docetaxel · EG002: Crossover Adagrasib

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Splenic infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Aortic valve stenosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Cardiac arrest

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      44
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      44
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      169
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      44
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      44
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      44
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      44
    term
    Asthenia
Complete source fields
description
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    126
    deaths Num At Risk
    301
    description
    Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with Adagrasib tablet or capsule orally at a starting dose of 600 mg twice a day (BID).
    id
    EG000
    other Num Affected
    292
    other Num At Risk
    298
    serious Num Affected
    149
    serious Num At Risk
    298
    title
    Adagrasib
  2. deaths Num Affected
    53
    deaths Num At Risk
    152
    description
    Participants with Non Small Cell Lung Cancer (NSCLC) with KRAS G12C mutation and who have received prior therapy with a platinum-based regimen and an immune checkpoint inhibitor were administered in 3-week cycle with intravenous infusion of Docetaxel at 75 mg/m\^2 over 1 hour or according to institutional practices.
    id
    EG001
    other Num Affected
    129
    other Num At Risk
    140
    serious Num Affected
    50
    serious Num At Risk
    140
    title
    Docetaxel
  3. deaths Num Affected
    15
    deaths Num At Risk
    44
    description
    Eligible participants receiving Docetaxel earlier in the study switched to Adagrasib based on physician decision. Participants were administered with Adagrasib orally at a starting dose of 600 mg twice a day (BID).
    id
    EG002
    other Num Affected
    43
    other Num At Risk
    44
    serious Num Affected
    20
    serious Num At Risk
    44
    title
    Crossover Adagrasib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      44
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      44
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      169
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      44
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      44
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      44
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      44
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Splenic infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Aortic valve stenosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      298
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      140
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    term
    Cardiac arrest
time Frame
All cause mortality and non serious adverse events were reported from first first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks). Serious adverse events were collected from date of signing of informed consent form till 28 days after last dose (Up to approximately 111 weeks).

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

Preserved source evidence · Not medical advice