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| ID | Type | Description | Link |
|---|---|---|---|
| CA209-997 | Other Identifier | Bristol Meyers Squibb |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab | Experimental | Nivolumab starting 4-11 weeks after surgery for 6 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab 480 mg IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab | As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab. | AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab | As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one adverse while on treatment of nivolumab for a minimum of 30 days following the last dose of study treatment. Adverse Events were not collected beyond the 30 days following the last dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trisha Wise-Draper, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States | ||
| UC Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35653116 | Derived | Leddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab | Nivolumab starting 4-11 weeks after surgery for 6 doses. Nivolumab: Nivolumab 480 mg IV infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
39 subjects that received at least one dose of Nivolumab
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab | Nivolumab starting 4-11 weeks after surgery for 6 doses. Nivolumab: Nivolumab 480 mg IV infusion |
| 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 | Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab | As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab. | Posted | Count of Participants | Participants | AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months. |
|
|
AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
Definitions do not differ
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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 | Nivolumab | Nivolumab starting 4-11 weeks after surgery for 6 doses. | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal wall cellulitis | Infections and infestations | 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 | |
|---|---|---|---|---|
| Trisha Wise-Draper M.D., Ph.D. | University of Cincinnati Cancer Center | (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 | Oct 9, 2019 | Sep 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months. |
| Disease Free Survival | The primary endpoint of this study was disease free survival (DFS) at 2-years as measured from the time of treatment allocation to the first evidence of any tumor or death from any cause. The "median follow-up of 22.1 months" reflects the actual duration of follow-up across participants at the time of data analysis. While the outcome measure was designed to be assessed at the 2-year mark, not all participants had reached exactly 24 months of follow-up when the data were analyzed. Therefore, the median follow-up time represents the central tendency of the follow-up duration for the cohort. | Median follow up was 22.1 months |
| Disease Free Survival | 2 year |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| 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 |
|
| >10 pack year tobacco smoking history | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab | As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one adverse while on treatment of nivolumab for a minimum of 30 days following the last dose of study treatment. Adverse Events were not collected beyond the 30 days following the last dose. | Posted | Count of Participants | Participants | AE collection occurs during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months. |
|
|
|
| Secondary | Disease Free Survival | The primary endpoint of this study was disease free survival (DFS) at 2-years as measured from the time of treatment allocation to the first evidence of any tumor or death from any cause. The "median follow-up of 22.1 months" reflects the actual duration of follow-up across participants at the time of data analysis. While the outcome measure was designed to be assessed at the 2-year mark, not all participants had reached exactly 24 months of follow-up when the data were analyzed. Therefore, the median follow-up time represents the central tendency of the follow-up duration for the cohort. | Posted | Number | 95% Confidence Interval | percentage of participants | Median follow up was 22.1 months |
|
|
|
| Secondary | Disease Free Survival | 2-year DFS measured per-protocol from date of first nivolumab treatment | Posted | Number | 95% Confidence Interval | Percentage of subjects | 2 year |
|
|
|
| 39 |
| 9 |
| 39 |
| 37 |
| 39 |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Bone infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Malignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 5 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue 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 |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Baker's cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 5 | Systematic Assessment |
|
| Blisters on arm | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Bloody drainage at PEG site | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Candidiasis around PEG tube insertion site | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Chills | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Clogged feeding tube | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Colonic diverticulitis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | 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 |
|
| Decreased breath sounds | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Device related infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Difficulty waking from strange dreams | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Dislodged hearing tube | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Drooling | Gastrointestinal 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 |
|
| Dysarthria | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal 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 |
|
| Dysurua | Renal and urinary 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 |
|
| Edema face | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Epididymla orchitis | Reproductive system and breast disorders | CTCAE version 5 | Systematic Assessment |
|
| Erythematous patch | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Facial pain | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Fever | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Generalized edema | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Generalized itching | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Granuloma at flap | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Hair growth from flap | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Hyperphagia | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Hypokalemia | 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 |
|
| Hypoxia | Surgical and medical procedures | CTCAE version 5 | Systematic Assessment |
|
| Increased BUN | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Increased ESR, CRP | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Increased mucus at trach stoma | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Inflammed and bumpy on lips | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Irritibility | Psychiatric disorders | CTCAE version 5 | Systematic Assessment |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | CTCAE version 5 | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE version 5 | Systematic Assessment |
|
| Malaise | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal 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 and shoulder stiffness | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Neck edema | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE version 5 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Oral secretions | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| PEG pulled out | Injury, poisoning and procedural complications | 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 |
|
| Palpitations | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Pharyngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Pharyngeal wall black | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Pharyngeal wall edema | General disorders | CTCAE version 5 | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Pre-malignant lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 5 | Systematic Assessment |
|
| Pressure injury | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Rash on back | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Salivary bypass tube migrated | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | CTCAE version 5 | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Systolic murmur | Cardiac disorders | CTCAE version 5 | Systematic Assessment |
|
| TEP complication | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| TEP prosthesis leaking | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| TEP prothesis fell out, TE puncuture closed | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| TEP pulled through anterior mucosal tissue | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Tooth infection | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Tracheal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE version 5 | Systematic Assessment |
|
| Trismus | 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 tract infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE version 5 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE version 5 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE version 5 | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
| Yellow thick secretions from fistula | Infections and infestations | CTCAE version 5 | Systematic Assessment |
|
Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |