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NCT02224781 · ADVERSE EVENTS

Adverse events

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma · Source last updated 2026-08-28

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
Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
Other-event reporting threshold
5%

All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Immunotherapy)

IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies

83 / 131124 / 13131 / 135
Arm B (BRAF Inhibitor Therapy)

Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO

75 / 132129 / 13249 / 132
Arm C (BRAF Inhibitor Therapy)

Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO

17 / 2929 / 2916 / 30
Arm D (Immunotherapy)

IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies

24 / 5244 / 5229 / 52

Group identifiers: EG000: Arm A (Immunotherapy) · EG001: Arm B (BRAF Inhibitor Therapy) · EG002: Arm C (BRAF Inhibitor Therapy) · EG003: Arm D (Immunotherapy)

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
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Lymph node pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Blood and lymphatic system disorders - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Myocarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    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
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      52
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      52
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Chills
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Edema limbs
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      52
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      52
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Flu like symptoms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Malaise
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    General disorders and administration site conditions - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Alopecia
Complete source fields
description
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    135
    description
    IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    EG000
    other Num Affected
    124
    other Num At Risk
    131
    serious Num Affected
    83
    serious Num At Risk
    131
    title
    Arm A (Immunotherapy)
  2. deaths Num Affected
    49
    deaths Num At Risk
    132
    description
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO
    id
    EG001
    other Num Affected
    129
    other Num At Risk
    132
    serious Num Affected
    75
    serious Num At Risk
    132
    title
    Arm B (BRAF Inhibitor Therapy)
  3. deaths Num Affected
    16
    deaths Num At Risk
    30
    description
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO
    id
    EG002
    other Num Affected
    29
    other Num At Risk
    29
    serious Num Affected
    17
    serious Num At Risk
    29
    title
    Arm C (BRAF Inhibitor Therapy)
  4. deaths Num Affected
    29
    deaths Num At Risk
    52
    description
    IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    EG003
    other Num Affected
    44
    other Num At Risk
    52
    serious Num Affected
    24
    serious Num At Risk
    52
    title
    Arm D (Immunotherapy)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      52
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      52
    term
    Blood and lymphatic system disorders - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Chills
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Edema limbs
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      32
      num At Risk
      52
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      52
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Flu like symptoms
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Malaise
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    General disorders and administration site conditions - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Alopecia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Hearing impaired
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Lymph node pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Blood and lymphatic system disorders - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Myocarditis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      131
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      132
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      29
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Pericardial effusion
time Frame
Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years

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Preserved source evidence · Not medical advice