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NCT03854032 · ADVERSE EVENTS

Adverse events

Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck · Source last updated 2026-10-19

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 event reporting will begin after study treatment, unless the AE/SAE is caused by a study specific screening procedure, and continue until 100 days (for non-serious AEs) or 100 days (for SAEs) after the last day of study participation. Up to 14 months
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: BMS986205 + Nivolumab

Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days. Nivolumab: Given IV IDO1 Inhibitor BMS-986205: Given PO Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies

6 / 3130 / 310 / 31
Arm B: Group I - Nivolumab Only

Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days. Nivolumab: Given IV Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies

1 / 1111 / 110 / 11
Arm C: Group II - Nivolumab Only

Data from Contemporaneous Study 10237 (NCT03238365) participants who received Nivolumab alone prior to surgery is used as a historical controls under the current window of treatment (WOT), to bolster the control group.

1 / 2313 / 231 / 23

Group identifiers: EG000: Arm A: BMS986205 + Nivolumab · EG001: Arm B: Group I - Nivolumab Only · EG002: Arm C: Group II - Nivolumab Only

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Aspiration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Chronic obstructive pulmonary disease
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Respiratory, thoracic and mediastinal disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Shortness of breath
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Elevated Troponin
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Investigations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hematoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hypokalemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infraction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    neutropenic fever
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Vomiting

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      23
      num Events
      10
    term
    Rash
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Thyroiditis
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Endocrine disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Agitation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alanine aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alkaline phosphatase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Allergic Rhinitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      31
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Anorexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Appetite Change
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Arthralgia
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    31
    description
    Patients receive IDO1 inhibitor BMS-986205 PO QD. Beginning week 2, patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats for up to 5 weeks in the absence of disease progression or unacceptable toxicity. Patients showing a treatment response receive IDO1 inhibitor BMS-986205 PO QD for 4 additional weeks and receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 10. Those without a treatment response after 5 weeks undergo surgery within 7 days. Nivolumab: Given IV IDO1 Inhibitor BMS-986205: Given PO Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    31
    serious Num Affected
    6
    serious Num At Risk
    31
    title
    Arm A: BMS986205 + Nivolumab
  2. deaths Num Affected
    0
    deaths Num At Risk
    11
    description
    Patients receive nivolumab IV over 30 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients showing treatment response after 4 weeks receive nivolumab IV over 30 minutes on day 1, then undergo surgery at week 9. Those without a treatment response after 4 weeks undergo surgery within 7 days. Nivolumab: Given IV Therapeutic Conventional Surgery: Undergo Surgery Questionnaire Administration: Ancillary studies
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    1
    serious Num At Risk
    11
    title
    Arm B: Group I - Nivolumab Only
  3. deaths Num Affected
    1
    deaths Num At Risk
    23
    description
    Data from Contemporaneous Study 10237 (NCT03238365) participants who received Nivolumab alone prior to surgery is used as a historical controls under the current window of treatment (WOT), to bolster the control group.
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    23
    serious Num Affected
    1
    serious Num At Risk
    23
    title
    Arm C: Group II - Nivolumab Only
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      23
      num Events
      10
    term
    Rash
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Thyroiditis
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Endocrine disorders - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Abdominal Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Agitation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alanine aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Alkaline phosphatase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      31
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Allergic Rhinitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      31
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      11
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Anorexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Appetite Change
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Arthralgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Aspiration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Chronic obstructive pulmonary disease
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Respiratory, thoracic and mediastinal disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Shortness of breath
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Elevated Troponin
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Investigations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hematoma
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hypokalemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Myocardial infraction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    neutropenic fever
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      11
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Skin infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      11
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Vomiting
time Frame
Adverse event reporting will begin after study treatment, unless the AE/SAE is caused by a study specific screening procedure, and continue until 100 days (for non-serious AEs) or 100 days (for SAEs) after the last day of study participation. Up to 14 months

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Preserved source evidence · Not medical advice