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This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.
This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of PepCan (50 µg per peptide dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment by enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and 9), and by fluorescent activated cell sorter analysis will be made at times points at Visits 1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PepCan | Experimental | Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections. |
|
| Placebo | Placebo Comparator | Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PepCan | Biological | 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan. | To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan | To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms. Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. | Study completion, approximately 24 months after enrollment |
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Inclusion Criteria:
Able to provide informed consent
Male or female 18 years of age or older
Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) therapy within the previous 120 days
Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
Vital Signs recorded
Blood work done at Screening Visit
Willing and able to comply with the requirements of the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar T Atiq, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41646795 | Derived | Bivens E, Atiq O, Evans T, Bimali M, Brown G, Crane J, Darwish N, Faulkner JL, Govindarajan R, Johnson A, Kurilung A, Lazarenko O, Lu YC, Marsh K, Moreno M, Nookaew I, Robeson M, Sunde J, Ussery D, Vural E, Wilman M, Nakagawa M. A Randomized Double-Blind Placebo-Controlled Phase I/II Clinical Trial of a Human Papillomavirus Therapeutic Vaccine, PepCan, for Reducing Head and Neck Cancer Recurrence. medRxiv [Preprint]. 2026 Jan 12:2026.01.09.26343801. doi: 10.64898/2026.01.09.26343801. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PepCan | Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections. PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities |
| FG001 | Placebo | Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections. Placebo: 0.9% Saline solution per dose administered intradermally in the extremities |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PepCan | Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections. PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan. | To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician. | Participants with side effects occurring with 5% or more injections. | Posted | Number | adverse event | 2 years |
|
Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on 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 | PepCan | Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections. PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mayumi Nakagawa, M.D., Ph.D. | University of Arkansas for Medical Sciences | (501) 686-8635 | MNakagawa@uams.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 | Jan 5, 2024 | Aug 1, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2023 | Jul 20, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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PepCan or placebo randomized at a 3:1 ratio in a double-blinded design.
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| Placebo | Biological | 0.9% Saline solution per dose administered intradermally in the extremities |
|
|
| Efficacy Analysis (Intention to Treat) - PepCan | Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis. | Study completion, approximately 24 months after enrollment |
| Efficacy Analysis (Intention to Treat) - Placebo | Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis. | Study completion, approximately 24 months after enrollment |
| Efficacy Analysis (Per Protocol) - PepCan | The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis. | Study completion, approximately 24 months after enrollment |
| Efficacy Analysis (Per Protocol) - Placebo | The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis. | Study completion, approximately 24 months after enrollment |
| Withdrawal by Subject |
|
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections. Placebo: 0.9% Saline solution per dose administered intradermally in the extremities |
| 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 |
|
| White blood cells | White blood cell count in blood | Mean | Standard Deviation | 10^3 cells/μL |
|
| Hemoglobin | Hemoglobin amount in blood | Mean | Standard Deviation | g/dL |
|
| Hematocrit | Hematocrit is an indication of the percentage of blood volume composed of red blood cells. | Mean | Standard Deviation | % |
|
| Body mass index | Body mass index is a measure of body fat based on weight divided by height squared. | Mean | Standard Deviation | kg/m2 |
|
| Human papillomavirus status | Count of Participants | Participants |
|
| P16 | P16 is a surrogate marker for human papillomavirus infection. | Count of Participants | Participants |
|
| Human Papillomavirus/P16 | Ratio of human papillomavirus to P16 status. | Count of Participants | Participants |
|
| Tumor location | Count of Participants | Participants |
|
| TNM Staging, Tumor | The TNM staging system is a widely-used system for staging different types of cancer. The T portion of TNM refers to the size and extent of the main, or primary, tumor. Here, the frequency of participants with a given T stage is what is reported here. Higher grades/stages (e.g., T4) indicate larger tumors or more invasion into surrounding tissues. | Count of Participants | Participants |
|
| TNM Staging, Lymph node | The TNM staging system is a widely-used system for staging different types of cancer. The N portion of TNM refers to the number of nearby lymph nodes that have cancer. Here, the frequency of participants with a given N stage is what is reported here. Higher grades (e.g., N3) indicate more spread to nearby lymph nodes. | Number | participants |
|
| TNM Staging, Metastasis: M0 | Metastasis portion of the TNM Staging system, which is a cancer staging system. The TNM staging system is a widely-used system for staging different types of cancer. The M portion of TNM refers to whether the cancer has metastasized, or spread from the primary tumor to other parts of the body. Here, the frequency of participants with a given M stage is what is reported here. MX means that the metastasis cannot be measured. M0 means the cancer has not spread to other parts of the body. M1 means the cancer has spread to other parts of the body. | Number | participants |
|
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|
| Secondary | Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan | To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms. Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. | Patients who screen-failed or were considered ineligible were excluded from the ITT analysis and PP analysis.. | Posted | Count of Participants | Participants | Study completion, approximately 24 months after enrollment |
|
|
|
| Secondary | Efficacy Analysis (Intention to Treat) - PepCan | Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis. | Patients who screen-failed or were considered ineligible were excluded from the ITT analysis. | Posted | Count of Participants | Participants | Study completion, approximately 24 months after enrollment |
|
|
|
|
| Secondary | Efficacy Analysis (Intention to Treat) - Placebo | Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis. | Patients who screen-failed or were considered ineligible were excluded from the ITT analysis. | Posted | Count of Participants | Participants | Study completion, approximately 24 months after enrollment |
|
|
|
|
| Secondary | Efficacy Analysis (Per Protocol) - PepCan | The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis. | Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis. | Posted | Count of Participants | Participants | Study completion, approximately 24 months after enrollment |
|
|
|
|
| Secondary | Efficacy Analysis (Per Protocol) - Placebo | The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis. | Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis. | Posted | Count of Participants | Participants | Study completion, approximately 24 months after enrollment |
|
|
|
|
| 1 |
| 12 |
| 5 |
| 12 |
| 12 |
| 12 |
| EG001 | Placebo | Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections. Placebo: 0.9% Saline solution per dose administered intradermally in the extremities | 0 | 5 | 2 | 5 | 5 | 5 |
| Diarrhea | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Bacteremia | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 5 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE version 5 | Systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE version 5 | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE version 5 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE version 5 | Systematic Assessment |
|
| Blood antidiuretic hormone abnormal | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE version 5 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| Chills | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE version 5 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | CTCAE version 5 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE version 5 | Systematic Assessment |
|
| Edema face | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Endocrine disorders - Other, specify | Endocrine disorders | CTCAE version 5 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Facial pain | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Fever | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Gait disturbance | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Gastroparesis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | CTCAE version 5 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE version 5 | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE version 5 | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Malaise | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 5 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Pain | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | CTCAE version 5 | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Shingles | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Spasticity | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE version 5 | Systematic Assessment |
|
| Thrush | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE version 5 | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 5 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Vaccination complication | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Vascular disorders - Other, specify | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE version 5 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Neck edema | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Bone infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE version 5 | Systematic Assessment |
|
| Scleral disorder | Eye disorders | CTCAE version 5 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009370 |
| Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D017670 |
| Sodium Compounds |
| Withdrawn |
|
| Ineligible |
|