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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Adverse Effects | Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages. | All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution. |
| Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation | • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins. | 1 year |
| Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation | • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue | Change in distribution of the tumor immune microenvironment after Pembrolizumab administration in tumor biopsy tissue using markers of T cells and T cell activation using PD-L1 CPS. PD-L1 CPS is defined as the PD-L1 combined positive score. PD-L1 CPS is defined as Combined positivity score (CPS) was calculated by summing the numbers of PD-L1-positive tumor cells and immune cells and dividing by the total number of viable tumor cells. Additionally, PD-L1 is a protein that helps the body immune system remain in control. The denominator in this case is 72 subjects that were evaluable. Evaluable means the subject had a pre-surgery pembrolizumab and a biopsy taken. The numerators are explained below. |
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Inclusion Criteria:
Patients eligible for resection with one or more of the following
Must be willing to undergo definitive resection with neck dissection.
Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
Adequate labs
Appropriate staging imaging.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trisha Wise-Draper, MD, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville - James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42154530 | Derived | Bandaru R, Fu H, Zheng H, Liang J, Wang L, Gulati S, Hinrichs BH, Teng M, Zhang B, Kocherginsky M, Lin DC, Hildeman DA, Worden FP, Old MO, Dunlap NE, Kaczmar JM, Gillison ML, El-Gamal D, Wise Draper T, Liu Y. Genome-wide variation in cell-free DNA end motif entropy predicts immunotherapy response in head and neck cancer. J Clin Invest. 2026 May 19:e196284. doi: 10.1172/JCI196284. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab |
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2021 |
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| Surgery | Procedure | gross total surgical resection |
|
| Radiation Therapy | Radiation | 60-66 Gy over 6 weeks |
|
| Cisplatin | Drug | Weekly during radiation therapy for 6 doses only for patients with high risk pathological features |
|
| 1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken |
| Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation | • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins | 1 year |
| Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation | • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins. | 1 year |
| University of Michigan |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
This is the total number of subjects. Other sections report different subject numbers as they are subsets of 92.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Related Adverse Effects | Number of participants with treatment related adverse effects as assessed using CTCAE v4.0 of pembrolizumab when combined with radiation alone and chemoradiation. Compared as percentage of grade 3 and 4 adverse events with historical control percentages. | Posted | Count of Participants | Participants | All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution. |
|
|
| |||||||||||||||||||||||||||
| Primary | Disease Free Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation | • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins. | • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins. | Posted | Number | 95% Confidence Interval | percentage of high risk participants | 1 year |
|
| ||||||||||||||||||||||||||
| Primary | Disease Free Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation | • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins. | • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins. | Posted | Number | 95% Confidence Interval | percentage of intermediate participants | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Tumor Immune Response to Pembrolizumab as Defined by PD-L1 CPS in the Baseline Tumor Tissue | Change in distribution of the tumor immune microenvironment after Pembrolizumab administration in tumor biopsy tissue using markers of T cells and T cell activation using PD-L1 CPS. PD-L1 CPS is defined as the PD-L1 combined positive score. PD-L1 CPS is defined as Combined positivity score (CPS) was calculated by summing the numbers of PD-L1-positive tumor cells and immune cells and dividing by the total number of viable tumor cells. Additionally, PD-L1 is a protein that helps the body immune system remain in control. The denominator in this case is 72 subjects that were evaluable. Evaluable means the subject had a pre-surgery pembrolizumab and a biopsy taken. The numerators are explained below. | Posted | Count of Participants | Participants | 1 week between receiving a pre-surgery dose of pembrolizumab and surgery when the biopsy was taken |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival in Resected Intermediate Risk Patients Treated With Adjuvant Pembrolizumab and Radiation | • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins | • Intermediate risk is defined as those with biopsies that do not have the following features: extracapsular spread or those with positive surgical margins | Posted | Number | 95% Confidence Interval | percentage of intermediate participants | 1 year |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival in Resected High Risk Patients Treated With Adjuvant Pembrolizumab and Chemoradiation | • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins. | • High risk is defined as those with biopsies that have the following features: extracapsular spread or those with positive surgical margins. | Posted | Number | 95% Confidence Interval | percentage of high risk participants | 1 year |
|
|
All adverse events were recorded from the time the consent form is signed through 30 days following cessation of treatment. Any AE related to study drug after 30 days post treatment, subjects were followed until resolution, approximately 3.61 months.
Adverse events were reviewed for at all protocol specified timepoints by reviewing medical records, laboratory results and through subject self-report. Adverse events collection occurred from within the intent-to-treat population and therefore was inclusive of more subjects than those determined to be evaluable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab | Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin Pembrolizumab: Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses. Surgery: gross total surgical resection Radiation Therapy: 60-66 Gy over 6 weeks Cisplatin: Weekly during radiation therapy for 6 doses only for patients with high risk pathological features | 20 | 96 | 43 | 96 | 92 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorectal infection | Infections and infestations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bone infection | Infections and infestations | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Edema face | General disorders | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment | Hematochezia odynophagia |
| |
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment | alpha hemolytic strep left side neck abscess rupture Coagulase-negative staphylococci neck abscesses Multifocal pneumonia Intestinal infection due to Clostridium difficile Infection, right leg graft site |
| |
| Laryngeal fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | Systematic Assessment | Failure to thrive |
| |
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pancreatitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngeal fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hypoxemia |
| |
| Salivary gland infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Immune system disorders | Systematic Assessment |
| ||
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment | free flap failure |
| |
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Tracheal obstruction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tracheitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Venous injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
| ||
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Systematic Assessment |
| ||
| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Aphonia | Nervous system disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Autoimmune disorder | Immune system disorders | Systematic Assessment |
| ||
| Back Pain | General disorders | Systematic Assessment |
| ||
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Systematic Assessment | microcytic anemia Cervical adenopathy low iron and low iron saturation Eosinophilic leukocytosis blood clot |
| |
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Bone infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Bullous dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| cardiac disorders other specify | Cardiac disorders | Systematic Assessment | heart rate fluctuating between 30's - 100's |
| |
| CD4 lymphocytes decreased | Investigations | Systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Concentration impairment | Nervous system disorders | Systematic Assessment |
| ||
| confusion | Psychiatric disorders | Systematic Assessment |
| ||
| conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Cystitis noninfective | Renal and urinary disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Dental Caries | Gastrointestinal disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dry eye | Eye disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Duodenal hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Systematic Assessment | Ear clogging up and popping Ear popping and bleeding |
| |
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Edema face | General disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Endocrine disorders - Other, specify | Endocrine disorders | Systematic Assessment | Diabetes Mellitus |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Esophageal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| eye disorders - other, specify | Eye disorders | Systematic Assessment | redness on left lower lid |
| |
| Eyelid function disorder | Eye disorders | Systematic Assessment |
| ||
| Facial pain | General disorders | Systematic Assessment |
| ||
| Fall | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Fibrinogen decreased | Investigations | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flu like symptoms | General disorders | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment | unusual sensation R buccal mucosa mouth blisters odynophagia drooling Mouth sores thick secretions Lip blisters irritable bowels bloody stool |
| |
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment | raised lesion R mouth edge of flap decreased activity stoma pain |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Glucose intolerance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hallucinations | Psychiatric disorders | Systematic Assessment |
| ||
| head soft tissue necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatitis viral | Infections and infestations | Systematic Assessment |
| ||
| Vascular disorders - other, specify | Vascular disorders | Systematic Assessment | Transient elevated blood pressure |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Hyperuricemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoparathyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Immune system disorders - Other, specify | Immune system disorders | Systematic Assessment | Adenopathy |
| |
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment | Thrush, Various drainage Alpha hemolytic Strep & Parvimonas micra Neck infection/abcess mycobacterial abscessus jaw infection C. Difficile methicillin-resistant staphylococcus aureus |
| |
| Infusion related reaction | General disorders | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Systematic Assessment | Rotator Cuff Injury Chyle leak accidental trach decannulation pain or bleeding at G-tube site exposed bone in mouth\ Drain fell out fistula lip purulent - drainage buttock wound toe wound False Lumen Surgical flap failure |
| |
| INR increased | Investigations | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Investigations - Other, specify | Investigations | Systematic Assessment | decreased BUN decreased albumin ketones in urine Cold intolerance Increased BUN |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| lip infection | Infections and infestations | Systematic Assessment |
| ||
| Lip pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lipohypertrophy | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Localized edema | General disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Lymphedema | Vascular disorders | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count increased | Investigations | Systematic Assessment |
| ||
| memory impairment | Nervous system disorders | Systematic Assessment |
| ||
| Meningismus | Nervous system disorders | Systematic Assessment |
| ||
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | Systematic Assessment | Malnutrition |
| |
| Movements involuntary | Nervous system disorders | Systematic Assessment |
| ||
| Mucosal infection | Infections and infestations | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Muscle cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | Systematic Assessment | neck stiffness jaw pain Degenerative disc disease pain at graft site |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nail infection | Infections and infestations | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neck edema | General disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | lump in scrotum lipoma right neck cyst with discharge Left cheek papulae left kidney lesion on CT R elbow nodule/cyst |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | Systematic Assessment | lightheadedness imbalances |
| |
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| oral cavity fistula | Gastrointestinal disorders | Systematic Assessment |
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| Oral dysesthesia | Gastrointestinal disorders | Systematic Assessment |
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| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
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| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Papulopustular rash | Infections and infestations | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Periodontal disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Pharyngeal fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| photophobia | Eye disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Prostatic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Psychiatric disorders - Other, specify | Psychiatric disorders | Systematic Assessment | ETOH cognitive dysfunction post-traumatic stress disorder |
| |
| Psychosis | Psychiatric disorders | Systematic Assessment |
| ||
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pustular | Infections and infestations | Systematic Assessment |
| ||
| rectal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | Systematic Assessment | dysuria nocturia nitrites, bacteria, and WBC in urine |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Increased mucus rhonchi velopharyngeal inefficiency Subcutaneous emphysema |
| |
| Salivary duct inflammation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment | angular stomatitis oropharyngeal erythema skin breakdown posterior oropharynx erythema erythema cracked and bleeding lips Dermatitis Cellulitis autoimmune dermatitis Right facial skin blisters |
| |
| skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| skin induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin infection | Infections and infestations | Systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| stomach pain | Gastrointestinal disorders | Systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Superficial soft tissue fibrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Superficial thrombophlebitis | Vascular disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Surgical and Medical Procedure - Other, specify | Surgical and medical procedures | Systematic Assessment | total thyroidectomy and surgical dissection debulking flap intraoperative anastomosis failure Gastrostomy tube replacement Free Flap Failure |
| |
| Syncope | Nervous system disorders | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tracheal obstruction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Trigeminal nerve disorder | Nervous system disorders | Systematic Assessment |
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| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vasovagal reaction | Nervous system disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Voice alteration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Weight gain | Investigations | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound Infection | Infections and infestations | Systematic Assessment |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication but has the right to delay or extend publication or presentation timeframes for a period not to exceed 60 days after the initial review period when this would impact sponsor's ability to obtain patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trisha Wise-Draper, MD, PhD | University of Cincinnati | 513 558 2826 | wiseth@ucmail.uc.edu |
| Jan 28, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
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|