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NCT03082534 · ADVERSE EVENTS

Adverse events

Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma · Source last updated 2026-10-01

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
8 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1

PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.

19 / 3332 / 3327 / 33
Cohort 2

PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.

9 / 2525 / 2519 / 25
Cohort 3

PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.

6 / 1010 / 109 / 10
Cohort 4

cutaneous HNSCC Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.

5 / 1010 / 108 / 10

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3 · EG003: Cohort 4

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Electrocardiogram QT corrected interval prolonged
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Colitis

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
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      25
      num Events
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Heart Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hearing impairment
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      6
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Floaters
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cheilitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      33
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Diarrhea
Complete source fields
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    33
    description
    PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
    id
    EG000
    other Num Affected
    32
    other Num At Risk
    33
    serious Num Affected
    19
    serious Num At Risk
    33
    title
    Cohort 1
  2. deaths Num Affected
    19
    deaths Num At Risk
    25
    description
    PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
    id
    EG001
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    9
    serious Num At Risk
    25
    title
    Cohort 2
  3. deaths Num Affected
    9
    deaths Num At Risk
    10
    description
    PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    Cohort 3
  4. deaths Num Affected
    8
    deaths Num At Risk
    10
    description
    cutaneous HNSCC Pembrolizumab (Keytruda®): Pembrolizumab is administered on an outpatient basis. 200 mg pembrolizumab will be administered as a 30 minute (-5 min/+10 min) intravenous (IV) infusion every 3 weeks. Cetuximab (Erbitux®): The initial cetuximab dose of 400mg/m2 is administered on Cycle 1, Day 1 as a 120-minute IV infusion (maximum infusion rate 10mg/min).1 Subsequent weekly cetuximab doses of 250mg/m2 are administered as 60-minute IV infusions (maximum infusion rate 10mg/min). Pembrolizumab, Cetuximab: Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection. Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR.
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Cohort 4
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
      num Events
      9
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      25
      num Events
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Heart Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hearing impairment
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      33
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Blurred vision
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      6
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Floaters
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      33
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Cheilitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      33
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      33
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      25
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      25
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Atrial flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Electrocardiogram QT corrected interval prolonged
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      25
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Heart failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      33
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal distension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      33
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      25
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Colitis
time Frame
8 years

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