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| Name | Class |
|---|---|
| The Ottawa Hospital | OTHER |
| Lotte & John Hecht Memorial Foundation | OTHER |
| Gateway for Cancer Research | OTHER |
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There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.
The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | To receive 20 mg of melatonin nightly for 1 year post-surgery |
|
| Placebo | Placebo Comparator | To receive 20 mg placebo nightly for 1 year post-surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Dietary Supplement | 20 mgs ingested nightly |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Cancer Recurrence or Mortality - 2 Years | Disease-Free survival (DFS) at 2 years post-surgery. DFS is measured by the number of participants in both arms who have experienced a recurrence OR mortality at 2 years. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Participant-reported quality of life using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 (EORTC QLQ C-30) and Lung Cancer 13 (EORTC QLQ LC13) questionnaires. Scores represent a value from 0-100. Symptom and LC13 scale: 0 represents best health, 100 worst health. Global and functional scales: 100 represents best health, 0 represents worst health. Full scoring algorithms available here: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dugald MR Seely, ND, MSc | The Canadian College of Naturopathic Medicine | Principal Investigator |
| Andrew JE Seely, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelowna General Hospital | Kelowna | British Columbia | V1Y 4N7 | Canada | ||
| Fraser Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16207291 | Background | Mills E, Wu P, Seely D, Guyatt G. Melatonin in the treatment of cancer: a systematic review of randomized controlled trials and meta-analysis. J Pineal Res. 2005 Nov;39(4):360-6. doi: 10.1111/j.1600-079X.2005.00258.x. | |
| 22019490 | Background | Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21. |
| Label | URL |
|---|---|
| The Canadian College of Naturopathic Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | To receive 20 mg of melatonin nightly for 1 year melatonin: 20 mg ingested nightly |
| FG001 | Placebo | To receive matched supplement to the experimental arm in same schedule placebo: similar to experimental in all ways except for lack of active ingredient |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | To receive 20 mg of melatonin nightly for 1 year melatonin: 20 mgs ingested nightly |
| BG001 | Placebo | To receive matched supplement to the experimental arm in same schedule placebo: similar to experimental in all ways except for lack of active ingredient |
| 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 | Lung Cancer Recurrence or Mortality - 2 Years | Disease-Free survival (DFS) at 2 years post-surgery. DFS is measured by the number of participants in both arms who have experienced a recurrence OR mortality at 2 years. | Intention to treat - all participants analyzed. | Posted | Count of Participants | Participants | 2 years |
|
2 Years
An adverse event is any untoward medical occurrence in a patient administered a medicinal product which does not necessarily have to have a causal relationship with this treatment. A serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in prolonging of existing hospitalization, results in a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
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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 | Melatonin | To receive 20 mg of melatonin nightly for 1 year post-surgery | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Legacy, Clinical Trial Coordinator | The Centre for Health Innovation | 613-792-1222 | 1 | mlegacy@thechi.ca |
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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 | Dec 8, 2014 | Mar 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Dietary Supplement |
similar to experimental in all ways except for lack of active ingredient |
|
| 2 years |
| Fatigue | Measured using the Multidimensional Fatigue Inventory 20 (MFI-20) questionnaire. Scores are on a scale of 0-100, where 100 is the best health and 0 is the worst health. | 2 years |
| Sleep | Measured using the Medical Outcomes Study (MOS) Sleep Survey. Scales used were Sleep Adequacy and Sleep problems Index II. Scores are on a scale of 0-100. Sleep Adequacy: 100 represents best health; 0 represents worst health. Problems index: 0 represents best health; 100 represents worst health. | 2 years |
| Pain Levels | Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain. | 3 months |
| Anxiety | Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety. | 2 years |
| Depression | Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression. | 2 years |
| Adverse Events (Chemotherapy) | Number of participants who experienced an adverse event related to their adjuvant chemotherapy | 2 years |
| Lung Cancer Recurrence or Mortality - 5 Years | Measured as disease-free survival (DFS) at 5 years. DFS was measured by the incidence of a recurrence OR mortality up to 5 years post-surgery. | up to 5 years |
| Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values) | NK cell cytotoxicity changes from baseline to 6 months | 6 months |
| Adverse Events (Radiation) | Number of participants who experienced an adverse event related to their adjuvant radiation therapy | 2 years |
| Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups) | Differences in NK cell cytotoxicity between both arms | 6 months |
| Surrey |
| British Columbia |
| V3R 7P8 |
| Canada |
| QEII Health Sciences Centre/Capital Health | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| St. Joseph's/ McMaster University | Hamilton | Ontario | L8N 4A6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5C1 | Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1Y 1J7 | Canada |
| University Health Network | Toronto | Ontario | M5G 1Z5 | Canada |
| Institut universitaire de cardiologie et de pneumologie de Québec | Québec | G1V 4G5 | Canada |
| 33681747 | Derived | Seely D, Legacy M, Auer RC, Fazekas A, Delic E, Anstee C, Angka L, Kennedy MA, Tai LH, Zhang T, Maziak DE, Shamji FM, Sundaresan RS, Gilbert S, Villeneuve PJ, Ashrafi AS, Inculet R, Yasufuku K, Waddell TK, Finley C, Shargall Y, Plourde M, Fergusson DA, Ramsay T, Seely AJE. Adjuvant melatonin for the prevention of recurrence and mortality following lung cancer resection (AMPLCaRe): A randomized placebo controlled clinical trial. EClinicalMedicine. 2021 Feb 27;33:100763. doi: 10.1016/j.eclinm.2021.100763. eCollection 2021 Mar. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pre-Operative Chemotherapy or Radiation | Count of Participants | Participants |
|
| Smoking History | Count of Participants | Participants |
|
| Histological Subtype | Count of Participants | Participants |
|
| Incision Type | Count of Participants | Participants |
|
| Surgery Type | Count of Participants | Participants |
|
| Pathological Cancer Stage | Overall 7th Edition American Joint Committee on Cancer (AJCC) stage (I-IV) based on the TNM classification. T refers to tumor size, N refers to nearby lymph nodes and M represents metastasized (spread) to other parts of the body. This staging number is obtained as a sum of the TNM classification. The lower the number, the lower the cancer stage and the better the prognosis for the patient. The higher the stage, the worse the prognosis. | Count of Participants | Participants |
|
|
|
|
| Secondary | Quality of Life | Participant-reported quality of life using the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire C-30 (EORTC QLQ C-30) and Lung Cancer 13 (EORTC QLQ LC13) questionnaires. Scores represent a value from 0-100. Symptom and LC13 scale: 0 represents best health, 100 worst health. Global and functional scales: 100 represents best health, 0 represents worst health. Full scoring algorithms available here: https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf | Intention to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale of 0-100 | 2 years |
|
|
|
|
| Secondary | Fatigue | Measured using the Multidimensional Fatigue Inventory 20 (MFI-20) questionnaire. Scores are on a scale of 0-100, where 100 is the best health and 0 is the worst health. | Intention to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale of 0-100 | 2 years |
|
|
|
|
| Secondary | Sleep | Measured using the Medical Outcomes Study (MOS) Sleep Survey. Scales used were Sleep Adequacy and Sleep problems Index II. Scores are on a scale of 0-100. Sleep Adequacy: 100 represents best health; 0 represents worst health. Problems index: 0 represents best health; 100 represents worst health. | Intention to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale of 0-100 | 2 years |
|
|
|
|
| Secondary | Pain Levels | Calculated using the Brief Pain Inventory. Each scale ranges from 0-10, where 0 is no pain and 10 is the worst possible pain. | Only those recruited from the Ottawa Hospital were included in this analysis. | Posted | Mean | Standard Deviation | Score on a scale of 0-10 | 3 months |
|
|
|
| Secondary | Anxiety | Measured using the Beck Anxiety Inventory. Scored range from 0-63, where 0 is no anxiety and 63 is the worst possible anxiety. | Only participants recruited from The Ottawa Hospital were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale of 0-63 | 2 years |
|
|
|
| Secondary | Depression | Measured using the Beck Depression Inventory II. Scores range from 0-63, where 0 is no depression and 63 is the worst possible depression. | Only participants recruited from The Ottawa Hospital were included in the analysis. | Posted | Mean | Standard Deviation | Score on a scale of 0-63 | 2 years |
|
|
|
| Secondary | Adverse Events (Chemotherapy) | Number of participants who experienced an adverse event related to their adjuvant chemotherapy | Only those who received adjuvant chemotherapy were included in this analysis. | Posted | Count of Participants | Participants | 2 years |
|
|
|
|
| Secondary | Lung Cancer Recurrence or Mortality - 5 Years | Measured as disease-free survival (DFS) at 5 years. DFS was measured by the incidence of a recurrence OR mortality up to 5 years post-surgery. | Intention to treat - all participants analyzed. | Posted | Count of Participants | Participants | up to 5 years |
|
|
|
|
| Secondary | Blood Tests to Examine the Effects of Melatonin on the Immune System (Raw Values) | NK cell cytotoxicity changes from baseline to 6 months | Participants who qualified for the sub-study only. | Posted | Mean | Standard Error | Percent killing of K62 cells | 6 months |
|
|
|
|
| Secondary | Adverse Events (Radiation) | Number of participants who experienced an adverse event related to their adjuvant radiation therapy | Only those who received adjuvant radiation were included in this analysis. | Posted | Count of Participants | Participants | 2 years |
|
|
|
|
| Secondary | Blood Tests to Examine the Effects of Melatonin on the Immune System (Comparison Between Groups) | Differences in NK cell cytotoxicity between both arms | Only those who were enrolled in the sub study and qualified for analysis were included. | Posted | Mean | 95% Confidence Interval | Ratio of percent cytotoxicity | 6 months |
|
|
|
|
| 356 |
| 84 |
| 356 |
| 184 |
| 356 |
| EG001 | Placebo | To receive 20 mg placebo nightly for 1 year post-surgery placebo: similar to experimental in all ways except for lack of active ingredient | 91 | 353 | 89 | 353 | 166 | 353 |
| Neutropenia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Angina | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Aortic Valve Replacement | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Apical thrombosis | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| NSTEMI | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Pericardial Effusion | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| STEMI | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Left para-opthalmic aneurysm | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Retinal Tear | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Adbominal Abcess | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Cholecystitis | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Gall bladder removal | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Lower GI Bleeding | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Perforated Bowel | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| SBO | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Upper GI bleeding | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Dehydration | General disorders | CTCAE | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE | Non-systematic Assessment |
|
| Chest Infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Fever | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Back pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Back sprain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Broken elbow | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Discitis | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Hip replacement surgery | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Left above-knee amputation | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Left total knee arthroplasty | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Osteophyte fracture | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Patella and fibular fracture | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Shoulder Replacement Surgery | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Toe Amputation | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Weakness | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Bladder Cancer Recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Medullary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - thyroid nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Urothelial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| Pericarditis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| Aphasia | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Leptomeningeal disease | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Neuro-syncope | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Renal Caliculi | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Empyema | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Prolonged Air Leak | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Subcutaneous Emphysema | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Aneurism Surgery | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
|
| Completion thyroidectomy | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
|
| Resection of Liposarcoma | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
|
| Thoracotomy | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
|
| Total thyroidectomy | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
|
| Peripheral Ischemia | Vascular disorders | CTCAE | Non-systematic Assessment |
|
| Blood/bone marrow - Other (myelotoxicity) | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Elevated ALT | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| ELevated AST | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Elevated creatinine levels | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Elevated TNI | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Hyperglycemia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Thrombic event | Blood and lymphatic system disorders | CTCAE | Non-systematic Assessment |
|
| Angina | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Atrial Arrhythmia | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Cardiac - Intra-Op Bleeding | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Cardiac Embolism | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Coronary Artery Calcification | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Heart Palpitations | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Thoracic Aortic Calcification | Cardiac disorders | CTCAE | Non-systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | CTCAE | Non-systematic Assessment |
|
| Hot swollen ears | Ear and labyrinth disorders | CTCAE | Non-systematic Assessment |
|
| ruptured eardrum | Ear and labyrinth disorders | CTCAE | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | CTCAE | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Burning eyes | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Cataracts | Eye disorders | CTCAE | Non-systematic Assessment |
|
| decreased vision in left eye | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Itchiness of eyes | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Left eye pain (after starting chemo) | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Vision changes | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Vitreous detachment/flashing lights | Eye disorders | CTCAE | Non-systematic Assessment |
|
| Abdominal bloating | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Appetite changes | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Burping | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Dilaudid related withdrawal symptoms | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| GERD | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Ileostomy reversal | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Mouth Ulcers | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Thrush (mouth) | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| UGI Bleeding | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Ulcerative colitis flare up | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Allergic Reaction | General disorders | CTCAE | Non-systematic Assessment |
|
| Costovertebral angle tenderness | General disorders | CTCAE | Non-systematic Assessment |
|
| Dehydration | General disorders | CTCAE | Non-systematic Assessment |
|
| Desaturation | General disorders | CTCAE | Non-systematic Assessment |
|
| Failure to thrive | General disorders | CTCAE | Non-systematic Assessment |
|
| Fatgiue | General disorders | CTCAE | Non-systematic Assessment |
|
| Generally unwell | General disorders | CTCAE | Non-systematic Assessment |
|
| Hair loss | General disorders | CTCAE | Non-systematic Assessment |
|
| Hot flashes | General disorders | CTCAE | Non-systematic Assessment |
|
| Hyperthermia | General disorders | CTCAE | Non-systematic Assessment |
|
| Left vocal cord swelling | General disorders | CTCAE | Non-systematic Assessment |
|
| Loss of voice | General disorders | CTCAE | Non-systematic Assessment |
|
| Night sweats | General disorders | CTCAE | Non-systematic Assessment |
|
| Peripheral Edema | General disorders | CTCAE | Non-systematic Assessment |
|
| Phlebitis | General disorders | CTCAE | Non-systematic Assessment |
|
| Restlessness | General disorders | CTCAE | Non-systematic Assessment |
|
| Ulcer on tongue | General disorders | CTCAE | Non-systematic Assessment |
|
| Voice hoarseness | General disorders | CTCAE | Non-systematic Assessment |
|
| Weakness | General disorders | CTCAE | Non-systematic Assessment |
|
| Weight gain | General disorders | CTCAE | Non-systematic Assessment |
|
| Weight loss | General disorders | CTCAE | Non-systematic Assessment |
|
| Gall bladder attack | Hepatobiliary disorders | CTCAE | Non-systematic Assessment |
|
| bladder infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| C-Difficile | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Chest infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Cold/Flu Symptoms | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Fever | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Fungal lung infection (Aspergillus) | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Infectious Sebaceous Cyst | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Influenza | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Oral candida infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| pelvic sepsis | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Shingles | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Sinus infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| skin infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Surgical site infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Throat Infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE | Non-systematic Assessment |
|
| Back of tongue pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Back pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Bone pain in upper thigh | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Burn marks (arm) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Burning sensation of feet, mostly at night | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Burning sensation when going to bathroom | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Calf pain at night after starting chemo | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Chronic pain/post-thoracotomy discomfort | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| elbow pain (left) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Erythema and tenderness arm, site of IV needle | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Fracture - nose | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Fracture - wrist | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Fractured foot | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Fractures | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Joint pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Laceration - left fingers | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Left arm pain while on chemo | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Left hand tingling | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Left leg numbness | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Left shoulder and neck pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| leg cramps | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Leg/joint pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Lower back pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain (back) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain (leg) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain (ongoing issue from fibromyalgia) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain in left foot | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain in right side (tender to touch) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Pain in right side flank | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| pain left leg | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Postoperative Pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| R. Arm weakness | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Right arm weakness | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Severe stabbing pain in thighs | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Shoulder pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Sore back | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Sprained ankle | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Surgical Site Pain | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Swollen right hand (pain Rt 2 fingers) | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Tenderness to incision site | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Tooth Infection | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE | Non-systematic Assessment |
|
| inflammatory pseudo tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| New Neoplasm - Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE | Non-systematic Assessment |
|
| Cognitive dysfunction/loss of memory | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Hyperarousal | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Lighheadedness | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| loss of balance | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Memory difficulty | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Migrane | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Peripheral Neuropathy | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Restlessness leg syndrome | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Sensory neuropathy | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Spacey feeling | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Spinal Stenosis | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Subcostal neuropathy | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Vivid Dreams | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Anorexia | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE | Non-systematic Assessment |
|
| Anal fissures | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| burning sensation when urinating | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Difficulty Urinating | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Frequent urination | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| L. Kidney Cyst | Renal and urinary disorders | CTCAE | Non-systematic Assessment |
|
| Discomfort or pain - breast area Rt side | Reproductive system and breast disorders | CTCAE | Non-systematic Assessment |
|
| Pain - right breast (dense feeling) | Reproductive system and breast disorders | CTCAE | Non-systematic Assessment |
|
| Prolapsed uterus | Reproductive system and breast disorders | CTCAE | Non-systematic Assessment |
|
| Ulceration vagina mucosa | Reproductive system and breast disorders | CTCAE | Non-systematic Assessment |
|
| Air Leak | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Bonchitis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Bronchial infection | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Burning sensation back of throat | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Dry Cough | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Empyema | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Fungal lung infection (Aspergillus) | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Hemothorax | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Hiatal Hernia | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Interstitial lung disease progression | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Mucus in chest | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Pulmonary Hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Radiation pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Rib fractures | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Separated rib | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Subcutaneous Emphysema | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| dry mouth | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Increased thickness in nails | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Left vocal cord swelling | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Sclera derma | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| skin eruptions | Skin and subcutaneous tissue disorders | CTCAE | Non-systematic Assessment |
|
| Gall bladder removal | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
|
| Hernia | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
Not provided
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Symptom Scale (2Y) |
|
| Functional Scale (Baseline) |
|
| Functional Scale (1Y) |
|
| Functional Scale (2Y) |
|
| Global Scale (Baseline) |
|
| Global Scale (1Y) |
|
| Global Scale (2Y) |
|
| LC13 Scale (Baseline) |
|
| LC13 Scale (1Y) |
|
| LC13 Scale (2Y) |
|
Analysis for Symptom Scale. |
| Mixed Models Analysis |
| 0.80 |
Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention. |
| Mean Difference (Net) |
| 0.4 |
| 2-Sided |
| 95 |
| -2.5 |
| 3.3 |
| Superiority |
| Analysis for Functional Scale. | Mixed Models Analysis | 0.69 | Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention. | Mean Difference (Net) | -0.7 | 2-Sided | 95 | -4.1 | 2.7 | Superiority |
| Analysis for Global Scale. | Mixed Models Analysis | 0.11 | Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention. | Mean Difference (Net) | -3.8 | 2-Sided | 95 | -8.5 | 0.9 | Superiority |
| 2Y |
|
| Sleep Adequacy (2Y) |
|
| Sleep Problems Index II (baseline) |
|
| Sleep Problems Index II (1Y) |
|
| Sleep Problems Index II (2Y) |
|
Sleep problems index II analysis. |
| Mixed Models Analysis |
Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention. |
| 0.41 |
| Mean Difference (Net) |
| 1.4 |
| 2-Sided |
| 95 |
| -2.0 |
| 4.8 |
| Superiority |
| Early Stage Cancer |
|
|
| Late Stage Cancer |
|
|
This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history. |
| Log Rank |
| 0.66 |
| Hazard Ratio (HR) |
| 0.97 |
| 2-Sided |
| 95 |
| 0.85 |
| 1.11 |
| Superiority |
| This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history. | Log Rank | 0.004 | Hazard Ratio (HR) | 0.75 | 2-Sided | 95 | 0.61 | 0.92 | Superiority |
| 0.02 |
| Mean Difference (Final Values) |
| 3.63 |
| 2-Sided |
| 95 |
| -0.15 |
| 7.42 |
| Superiority |