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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
Recurrent and/or metastatic HNSCC patients will be treated with combination of metformin and pembrolizumab. Patients will be randomized into arms 1 and 2, to either receive Metformin prior to pembrolizumab or to begin Metformin after pembrolizumab treatment begins. The patients are randomized for the exploratory endpoints in order to better understand the difference of effects of metformin versus pembrolizumab on the immune system although efficacy is based on combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Metformin before Pembrolizumab | Experimental | Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily. |
|
| Arm 2: Metformin after Pembrolizumab | Experimental | D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Extended Release Oral Tablet | Drug | Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate by RECIST 1.1 and iRECIST | A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial response or progressive disease. | Up to 2 years after completion of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events Measured by CTCAE v5.0 | To observe and record safety of combination in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) patients receiving the combination of metformin and pembrolizumab. AEs will be graded and recorded according to NCI CTCAE Version 5.0. | 2 years |
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Inclusion Criteria:
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 Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Metformin Before Pembrolizumab | Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks |
| FG001 | Arm 2: Metformin After Pembrolizumab | D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Metformin Before Pembrolizumab | Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overall Response Rate by RECIST 1.1 and iRECIST | A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial response or progressive disease. | Of the 21 subjects, only 18 were evaluable via RECIST 1.0 and iRECIST. | Posted | Count of Participants | Participants | Up to 2 years after completion of study treatment |
|
All adverse events were collected continuously during the treatment period and for a minimum of 90 days following the last dose of study treatment, up to 1 year.
Does not differ from clinicaltrials.gov.
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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 | Arm 1: Metformin Before Pembrolizumab | Metformin ER 1000mg daily D-14 to D-7. Metformin ER 2000mg daily D-7 to D1. D1 Begin Pembrolizumab 200mg every 3 weeks, while continuing Metformin ER 2000mg daily. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trisha Wise-Draper, MD PHD | University of Cincinnati | (513) 558-2826 | wiseth@ucmail.uc.edu |
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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 4, 2024 | Feb 19, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Patients will be on one of two arms that will be studied in parallel.
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|
| Pembrolizumab | Drug | Pembrolizumab q 3 weeks |
|
|
| Progression Free Survival (PFS) |
To observe and record progression free survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab. |
| 1 year |
| Overall Survival (OS) | Overall survival was analyzed using the Kaplan-Meier method. The reported 1-year overall survival percentages represent Kaplan-Meier-estimated probabilities of survival at 1 year and do not correspond to the observed proportion of participants alive or deceased due to censoring. Observed all-cause mortality is reported separately as the number of participants who died due to any cause in each arm. | 1 year |
| BG001 |
| Arm 2: Metformin After Pembrolizumab |
D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking History (>=10 pack years) | Count of Participants | Participants |
|
| OG001 | Arm 2: Metformin After Pembrolizumab | D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks |
|
|
| Secondary | Number of Patients With Adverse Events Measured by CTCAE v5.0 | To observe and record safety of combination in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) patients receiving the combination of metformin and pembrolizumab. AEs will be graded and recorded according to NCI CTCAE Version 5.0. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Progression Free Survival (PFS) | To observe and record progression free survival in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab. | Posted | Median | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival was analyzed using the Kaplan-Meier method. The reported 1-year overall survival percentages represent Kaplan-Meier-estimated probabilities of survival at 1 year and do not correspond to the observed proportion of participants alive or deceased due to censoring. Observed all-cause mortality is reported separately as the number of participants who died due to any cause in each arm. | Posted | Median | 95% Confidence Interval | percentage of patients who are alive | 1 year |
|
|
|
| 6 |
| 10 |
| 3 |
| 10 |
| 10 |
| 10 |
| EG001 | Arm 2: Metformin After Pembrolizumab | D-21 Begin Pembrolizumab 200mg. D-7 begin Metformin ER 1000mg daily. D1 begin Metformin ER 2000mg daily. Continue Pembrolizumab 200mg every 3 weeks. Metformin Extended Release Oral Tablet: Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily Pembrolizumab: Pembrolizumab q 3 weeks | 8 | 11 | 4 | 11 | 11 | 11 |
| Cardiac arrest | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Hip dislocation | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Port site infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Abdominal nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anosmia | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Autoimmune Dermatitis | Immune system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Buttock Wound | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Excessive Saliva Production | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Folate Deficiency | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Gait disturbance | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Blood in stool | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hot sensation around ears | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hyperphagia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypochloremia | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Increased BUN | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Increased lactate | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Knee and shoulder ache | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Lung inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neck edema | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Neck Stiffness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Normocytic Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pain in shoulder | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Parasomnia | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Polydypsia | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pruritus Rash | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Cutaneous Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| Sebaceous nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| Sepsis | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| Upper chest burning sensation | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| Vitamin B12 Deficiency | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |