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This Canadian, multi-centre, prospective, observational real-world study is designed to collect patient-reported outcome data on the use of Akynzeo® (netupitant/palonosetron) for the prevention of nausea and vomiting in oncology patients receiving highly emetogenic chemotherapy (HEC).
The study will assess quality of life using the Functional Living Index of Emesis (FLIE) questionnaire and generate Real World Evidence in support of existing clinical trial data, including effectiveness and safety of Akynzeo® in the real world setting for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 300mg netupitant/0.5mg palonosetron hydrochloride | Drug | Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist) |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 | The Functional Living Index - Emesis questionnaire is a validated patient reported outcome with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function. Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (100 mm) and an ordinal scale (where 1= no emesis-7=a great deal). The minimum total score is 18 and the maximum total score is 126. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. A FLIE total score > 108 indicates no impairment on daily life as a result of nausea or vomiting. Assessed by patient following day 5 of each cycle. | Day 5 of cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5) | Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days |
| Severity of Nausea on Day 5 (Change From Day 1) |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
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This study will enroll adult male or female chemotherapy patients of various cancer types who are scheduled to receive chemotherapy with high emetogenic potential for a maximum of 2 days.
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| Name | Affiliation | Role |
|---|---|---|
| Jodan Ratz, PhD | Purdue Pharma, Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Center | Calgary | Alberta | Canada | |||
| The Moncton Hospital |
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Participants were recruited from cancer treatment centers based on physician review of medical charts from the recruiting physicians clinical practice and referral from other physicians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 300mg netupitant/0.5mg palonosetron hydrochloride |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 5, 2018 |
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Question 1 of the daily evaluation of the Patient Diary ("How much nausea did you experience on average during the last 24 hours?"). Data was collected on a visual analogue scale. Scale ranges from 0 mm ("no nausea") to 100 mm ("always severe nausea").
| Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days |
| Moncton |
| New Brunswick |
| Canada |
| NSHA-QEII Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Cape Breton Cancer Centre | Sydney | Nova Scotia | Canada |
| Royal Victoria Regional Health Centre | Barrie | Ontario | Canada |
| William Osler Health System | Brampton | Ontario | Canada |
| Grand River Regional Cancer Centre | Kitchener | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Center | Toronto | Ontario | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | Canada |
| Centre Integre de Sante et de Services Sociaux de la Monteregie-Centre | Greenfield Park | Quebec | Canada |
| Cisss de Chaudiere-Appalaches | Lévis | Quebec | Canada |
| Segal Cancer Centre-Jewish General Hospital | Montreal | Quebec | Canada |
| Centre de recherche du CHUS and Hopital Fleurimont | Sherbrooke | Quebec | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada |
| COMPLETED |
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| NOT COMPLETED |
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The modified intent-to-treat population includes all patients who were included in the ITT population and fulfilled all entry criteria and received at least one dose of the study treatment. 10 patients in the ITT population did not receive at least one dose of the study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Intent-to-Treat Population | 300mg netupitant/0.5mg palonosetron hydrochloride |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | This study was only conducted in Canada. | Count of Participants | Participants |
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| 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 | Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 | The Functional Living Index - Emesis questionnaire is a validated patient reported outcome with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function. Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (100 mm) and an ordinal scale (where 1= no emesis-7=a great deal). The minimum total score is 18 and the maximum total score is 126. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. A FLIE total score > 108 indicates no impairment on daily life as a result of nausea or vomiting. Assessed by patient following day 5 of each cycle. | mITT | Posted | Mean | Standard Deviation | score on a scale | Day 5 of cycle 1 |
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| Secondary | Complete Response | No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5) | mITT | Posted | Count of Participants | Participants | Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days |
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| Secondary | Severity of Nausea on Day 5 (Change From Day 1) | Question 1 of the daily evaluation of the Patient Diary ("How much nausea did you experience on average during the last 24 hours?"). Data was collected on a visual analogue scale. Scale ranges from 0 mm ("no nausea") to 100 mm ("always severe nausea"). | mITT | Posted | Mean | Standard Deviation | mm | Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days |
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The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit
The safety population was equivalent to the modified intent to treat population (n=197) and included all patients who received at least one dose of the study treatment. Patients reported adverse events (excluding nausea and vomiting) in a diary from Day 1 to Day 5 post chemotherapy administration of each observation period. Safety events occurring between chemotherapy cycles were reported by the patient. Patients had a follow up period of 28 days post the last-chemotherapy cycle.
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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 | Treatment | 300mg netupitant/0.5mg palonosetron hydrochloride | 9 | 197 | 39 | 197 | 178 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Metapneumovirus Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Upper respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Anal Ulcer | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Diverticular Perforation | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Disease Progression | General disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Sudden Death | General disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Lower Gastrointestinal Haemorrhage | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Septic Shock | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Device Related Infection | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Escherichia Bacteraemia | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Hallucination, Visual | Psychiatric disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Panic Attack | Psychiatric disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cancer Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Non-systematic Assessment |
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| Eosinophilic Cystitis | Renal and urinary disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Decreased Appetite | General disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (21.1) | Non-systematic Assessment |
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The study was observational and open-label, lacking a control arm and randomization. Moreover, the study included mostly female patients and a high proportion of patients with breast or lung cancer, which may limit the generalizability of the study findings. Although "Quality of Life" data are subjective by nature, the FLIE questionnaire is validated, which minimizes the subjectivity of the patient-reported data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graeme Donnelly | Purdue Pharma (Canada) | 905.837-6498 | graeme.donnelly@purdue.ca |
| Jun 24, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595957 | netupitant, palosentron drug combination |
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| other |
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