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NCT04303780 · ADVERSE EVENTS

Adverse events

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). · Source last updated 2026-07-22

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:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.
Other-event reporting threshold
5%

Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.

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

Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).

67 / 151129 / 15178 / 174
AMG 510

Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.

91 / 169151 / 169109 / 171
Docetaxel, Then Switched to AMG 510

Participants who were randomized to originally receive docetaxel, who were determined to have radiological progression according to RECIST v1.1 by the investigator and progressive disease confirmed by independent central imaging review, and switched to receive AMG 510. Alternatively, participants could switch from docetaxel to receive AMG 510 if an early efficacy of the study is noted by the data monitoring committee.

26 / 4635 / 4617 / 46

Group identifiers: EG000: Docetaxel · EG001: AMG 510 · EG002: Docetaxel, Then Switched to AMG 510

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Cardiac tamponade
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    term
    Coronary artery disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Myocardial infarction

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      46
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      46
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      46
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      46
    term
    Fatigue
Complete source fields
description
Serious and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all randomized participants. As pre-specified in the statistical analysis plan, data are reported per treatment received, including participants who were randomized to docetaxel and switched to AMG 510.
event Groups
  1. deaths Num Affected
    78
    deaths Num At Risk
    174
    description
    Participants with previously treated locally advanced and unresectable or metastatic NSCLC with centrally confirmed KRAS p.G12C mutation received 75 mg/m\^2 of docetaxel via intravenous (IV) infusion once every 3 weeks (Q3W) in each 21 day cycle. Participants who were determined to have radiological progression according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by the investigator and progressive disease confirmed by independent central imaging review, could have switched to receive AMG 510. Alternatively, if an early efficacy of the study is noted by the data monitoring committee, crossover would be considered for all participants who randomized into the docetaxel arm (so that they are able to immediately receive AMG 510).
    id
    EG000
    other Num Affected
    129
    other Num At Risk
    151
    serious Num Affected
    67
    serious Num At Risk
    151
    title
    Docetaxel
  2. deaths Num Affected
    109
    deaths Num At Risk
    171
    description
    Participants with previously treated locally advanced and unresectable or metastatic non small cell lung cancer (NSCLC) with centrally confirmed Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation received 960 mg of AMG 510 orally via tablets once a day (QD) in each 21 day cycle.
    id
    EG001
    other Num Affected
    151
    other Num At Risk
    169
    serious Num Affected
    91
    serious Num At Risk
    169
    title
    AMG 510
  3. deaths Num Affected
    17
    deaths Num At Risk
    46
    description
    Participants who were randomized to originally receive docetaxel, who were determined to have radiological progression according to RECIST v1.1 by the investigator and progressive disease confirmed by independent central imaging review, and switched to receive AMG 510. Alternatively, participants could switch from docetaxel to receive AMG 510 if an early efficacy of the study is noted by the data monitoring committee.
    id
    EG002
    other Num Affected
    35
    other Num At Risk
    46
    serious Num Affected
    26
    serious Num At Risk
    46
    title
    Docetaxel, Then Switched to AMG 510
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      46
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      46
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      46
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      46
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
    term
    Chest pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      46
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Cardiac arrest
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Cardiac tamponade
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
    term
    Coronary artery disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      151
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      169
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
    term
    Myocardial infarction
time Frame
Adverse events:for 'Docetaxel' and 'AMG 510', from first dose(FD) to 30 days post last dose, or before FD of AMG 510 if participants cross over, or end of study (EOS) or data cut-off (DCO) which occurred earliest; median[min,max] duration 4.06[0.2,23.7] mons. For 'Docetaxel, then Switched to AMG 510', from FD to EOS/DCO which occurred earliest; median[min,max] duration 7.97[0.8,15.2] mons. Mortality:from randomization until death or DCO; median[min,max] time on study 14.78[0.2,24.3] mons.

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Preserved source evidence · Not medical advice