Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study. Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential. In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics: 1. nausea and/or vomiting in the prior cycle of chemotherapy 2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy 3. platinum or anthracycline-based chemotherapy 4. age \< 60 years 5. expectations for (anticipating) nausea and/or vomiting 6. \<7 h of sleep the night before chemotherapy 7. history of morning sickness during previous pregnancy 8. cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.
Detailed description
Antiemetic guideline recommendations are based on the emetogenic potential of chemotherapy and involve 4 levels of classification of intravenous chemotherapy agents, i.e., high, moderate, low and minimal; these have been accepted by major organisations. Moderate emetogenic chemotherapy (MEC) results in acute vomiting in 30% to 90% of cancer patients in the absence of antiemetic therapy. In addition to the chemotherapy type, several patient-related risk factors and clinical characteristics can increase CINV risk. These can include use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, no complete CINV response in an earlier cycle, history of nausea/vomiting, (trait) anxiety, fatigue experience, and expectations of nausea/vomiting. Other studies have largely confirmed some of the key risk factors for CINV (history of vomiting during pregnancy, history of motion sickness, age, gender) and added other factors such as (chronic) alcohol consumption, body surface area, fewer hours slept the night prior to infusion, or advanced stage cancer. Currently, there is a limited consensus surrounding the most relevant patient risk factors that may predict CINV risk. Based on a recent study by Dranitsaris et al. eight predictive factors have been identified, and an algorithm has been developed to combine these patient-related risk factors into the optimal treatment of prophylactic antiemetics. These include: 1. nausea and/or vomiting in the prior cycle of chemotherapy 2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy 3. platinum or anthracycline-based chemotherapy 4. age \< 60 years 5. expectations for (anticipating) nausea and/or vomiting 6. \<7 h of sleep the night before chemotherapy 7. history of morning sickness during previous pregnancy 8. cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). Akynzeo®, an oral combination of the neurokinin 1 receptor antagonists (NK1 RA), netupitant and the 5-hydroxytryptamine (HT3) receptor antagonists (5-HT3 RA), palonosetron, is recommended by guidelines for the prevention of CINV. Akynzeo® has been evaluated in a multicentre, randomised, double-blind, double-dummy phase II clinical trial at various dose ranges among 694 cisplatin-treated cancer patients from 44 sites (two countries); each NEPA (netupitant-palonosetron) dose significantly improves CINV prevention in cancer patients. Similar results were obtained in another international, randomised, double-blind and parallel group phase III clinical trial; NEPA prevented CINV in patients receiving MEC. The current study primarily aimed to evaluate whether Akynzeo® leads to a higher response rate compared with standard care in MEC regimen-treated patients who are identified to be at high risk based on the algorithm.
Interventions
Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
DRUGGranisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)
Standard of care will be administered on Day 1 of each cycle.
DRUGDexamethasone, 8 mg (oral) or equivalent IV dose
Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
Sponsors
Helsinn Healthcare SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
interventional, open label, randomized, active controlled, parallel arms, multicenter and multinational study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged ≥18 years * Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1. Baseline/screening: VISIT 0 * Signed Informed consent * Both sexes * Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy * Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention * Naïve and non- naïve to chemotherapy * The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records * Able to comply with study requirements
Exclusion criteria
* Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy) * Patients receiving oral moderately emetogenic chemotherapy drugs * Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed) * Use of olanzapine as prophylaxis of CINV * Patients scheduled to receive radiotherapy concurrently with chemotherapy * Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient. * Patients with mechanical risk factors for nausea (i.e. intestinal obstruction) * Patients with liver disease (as nausea is a common presenting symptom) * Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting) * Chronic treatment with steroids (with the exception of inhaled or topical steroids) * Pregnancy and/or breast-feeding women * Women of childbearing potential refusing to use effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo® * Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration | At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than a standard of care antiemetics over three cycles of chemotherapy. The primary endpoint is the probability of complete responses (no emetic episode and no rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three cycles of chemotherapy. This endpoint is evaluated in patients with at least one reported cycle assessment. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a per cycle CINV Indicators between the treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Probability of: * No emetic episode during the acute, delayed, and overall phase and daily in each cycle * No rescue medication during the acute, delayed, and overall phase and daily in each cycle * No significant nausea (maximum MAT scale = 2) during the acute, delayed, and overall phase and daily in each cycle; * No nausea (MAT scale = 0) during the acute, delayed, and overall phase and daily in each cycle; * Complete protection (no emetic episode, no rescue medication, and no significant nausea) during the acute, delayed, and overall phase and daily in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a per cycle CINV Indicators between the treatment arms. |
| Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Analysis of the development of CINV as a dependent variable will be performed to identify additional potential risk factors of CINV thought to be increasing the risk of CINV in patients receiving MEC. The outcome measure is the development of CINV, defined as any occurrence of nausea or a vomiting episode. The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT). |
| Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | An overall summary of adverse events (AE) will be presented, including the frequency of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug |
| Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | An overall summary of adverse events (AE) will be presented, including the percentage of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug |
| Number of Participants With Discontinuations Due to Adverse Events | At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | The frequency of discontinuations due to adverse events (AE) will be presented. |
| Percentage of Participants With Discontinuations Due to Adverse Events | At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | The percentage of patients with discontinuations due to adverse events (AE) will be presented. |
| Number of Participants With Death Due to Adverse Events | At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | The frequency of on treatment deaths due to adverse events (AE) will be presented. |
| Percentage of Participants With Death Due to Adverse Events | At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | The percentage of patients with on treatment death due to adverse events (AE) will be presented. All AEs leading to on treatment death will be summarized by their: * Severity * Seriousness * Relationship to a drug |
| Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Evaluation of the effect of CINV on daily activities and quality of life that will be measured by using the Functional Living Index-Emesis (FLIE) questionnaire, a validated, nausea and vomiting specific, patient-reported outcome instrument. The Functional Living Index-Emesis (FLIE) has 18 questions. These questions are divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). The minimum score for any question is 0 and the maximum score is 100. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. The model-based statistics of generalized linear model were used to calculate the difference in the score per cycle between the treatment arms. |
| Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of days with rescue medication administered for the treatment of CINV, will be evaluated during the study cycles |
| Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles |
| Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of re-hydration bags given for at least grade 2 vomiting (more details below), will be evaluated during the study cycles |
| Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of days of unplanned hospitalizations related to CINV, will be evaluated during the study cycles All hospitalizations will be summarized according to the department of hospitalization (type of ward) |
| Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner), will be evaluated during the study cycles |
| Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of unplanned laboratory test including those at unplanned hospitalizations due to CINV, will be evaluated during the study cycles |
| Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of discontinuations of chemotherapy treatment due to CINV, will be evaluated during the study cycles |
| Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV | At the start of cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of delays of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3. |
| Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV | At the start of Cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the average length of delay (in days) of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3. |
| Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Health economic endpoint, the number of days of absence from work, will be evaluated during the study cycles |
| Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks). | Number of vomiting episodes during the acute, delayed, and overall phase in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the number of vomiting episodes per cycle between the treatment arms. |
Countries
China, Czechia, Germany, Greece, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
The Full Analysis Set (FAS) consists of 401 (NEPA: 196, SoC: 205) randomised patients to whom study drug was dispensed. It was the primary basis for the analyses of efficacy.
Participants by arm
| Arm | Count |
|---|---|
| NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone (8 mg) will be administered on Day 1 of each cycle. | 196 |
| Standard of Care + Dexamethasone 8 mg Dexamethasone (or equivalent corticosteroids) 8 mg administered by the oral route (or equivalent IV dose) on Day 1, approximately 1 hour before chemotherapy and one of the 5-HT3-RAs recommended by European Society for Medical Oncology (ESMO) and Multinational Association of Supportive Care in Cancer (MASCC) guidelines (standard of care), i.e. either:
Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV) | 205 |
| Total | 401 |
Baseline characteristics
| Characteristic | NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg | Standard of Care + Dexamethasone 8 mg | Total |
|---|---|---|---|
| Age, Continuous | 62.7 year STANDARD_DEVIATION 11.8 | 62.7 year STANDARD_DEVIATION 11.3 | 62.7 year STANDARD_DEVIATION 11.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 93 Participants | 87 Participants | 180 Participants |
| Sex: Female, Male Male | 103 Participants | 118 Participants | 221 Participants |
| weight | 73.28 kg STANDARD_DEVIATION 16.001 | 74.78 kg STANDARD_DEVIATION 17.285 | 74.05 kg STANDARD_DEVIATION 16.666 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 196 | 2 / 205 |
| other Total, other adverse events | 150 / 196 | 150 / 205 |
| serious Total, serious adverse events | 22 / 196 | 23 / 205 |
Outcome results
Primary
The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration
To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than a standard of care antiemetics over three cycles of chemotherapy. The primary endpoint is the probability of complete responses (no emetic episode and no rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three cycles of chemotherapy. This endpoint is evaluated in patients with at least one reported cycle assessment. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a per cycle CINV Indicators between the treatment arms.
Time frame: At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Population: The Full Analysis Set (FAS) consists of 401 (NEPA: 196, SoC: 205) randomised patients to whom study drug was dispensed. It was the primary basis for the analyses of efficacy. Following the intent-to-treat principle, patients in the FAS population will be analysed according to the treatment to which they were randomised. The primary endpoint within the FAS was analysed based on data from 388 (NEPA: 189, SoC: 199) patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration | 0.810 Probability of complete response |
| Standard of care + Dexamethasone 8 mg | The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration | 0.718 Probability of complete response |
p-value: <0.0595% CI: [1.12, 2.49]generalized linear model
Secondary
Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy
Number of vomiting episodes during the acute, delayed, and overall phase in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the number of vomiting episodes per cycle between the treatment arms.
Time frame: At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Population: Full analysis set. Patients with evaluable data in cycle 1 and eligible for imputation, using last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 overall phase - Number of vomiting episodes | 0.15 Number of vomiting episodes | Standard Deviation 0.837 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 acute phase - Number of vomiting episodes | 0.04 Number of vomiting episodes | Standard Deviation 0.3 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 acute phase - Number of vomiting episodes | 0.04 Number of vomiting episodes | Standard Deviation 0.316 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 acute phase - Number of vomiting episodes | 0.05 Number of vomiting episodes | Standard Deviation 0.422 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 delayed phase - Number of vomiting episodes | 0.08 Number of vomiting episodes | Standard Deviation 0.425 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 delayed phase - Number of vomiting episodes | 0.06 Number of vomiting episodes | Standard Deviation 0.44 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 delayed phase - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.701 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 2 - Number of vomiting episodes | 0.03 Number of vomiting episodes | Standard Deviation 0.23 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 2 - Number of vomiting episodes | 0.02 Number of vomiting episodes | Standard Deviation 0.177 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 2 - Number of vomiting episodes | 0.05 Number of vomiting episodes | Standard Deviation 0.422 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 3 - Number of vomiting episodes | 0.07 Number of vomiting episodes | Standard Deviation 0.433 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 3 - Number of vomiting episodes | 0.09 Number of vomiting episodes | Standard Deviation 0.69 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 3 - Number of vomiting episodes | 0.09 Number of vomiting episodes | Standard Deviation 0.543 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 4 - Number of vomiting episodes | 0.05 Number of vomiting episodes | Standard Deviation 0.449 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 4 - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.67 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 4 - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.594 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 5 - Number of vomiting episodes | 0.05 Number of vomiting episodes | Standard Deviation 0.431 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 5 - Number of vomiting episodes | 0.06 Number of vomiting episodes | Standard Deviation 0.48 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 5 - Number of vomiting episodes | 0.07 Number of vomiting episodes | Standard Deviation 0.506 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 overall phase - Number of vomiting episodes | 0.11 Number of vomiting episodes | Standard Deviation 0.516 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 overall phase - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.585 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 3 - Number of vomiting episodes | 0.20 Number of vomiting episodes | Standard Deviation 0.825 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 overall phase - Number of vomiting episodes | 0.47 Number of vomiting episodes | Standard Deviation 1.909 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 5 - Number of vomiting episodes | 0.15 Number of vomiting episodes | Standard Deviation 0.792 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 acute phase - Number of vomiting episodes | 0.09 Number of vomiting episodes | Standard Deviation 0.494 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 3 - Number of vomiting episodes | 0.11 Number of vomiting episodes | Standard Deviation 0.579 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 acute phase - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.508 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 5 - Number of vomiting episodes | 0.07 Number of vomiting episodes | Standard Deviation 0.438 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 acute phase - Number of vomiting episodes | 0.11 Number of vomiting episodes | Standard Deviation 0.601 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 3 - Number of vomiting episodes | 0.17 Number of vomiting episodes | Standard Deviation 0.777 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 delayed phase - Number of vomiting episodes | 0.46 Number of vomiting episodes | Standard Deviation 1.579 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 overall phase - Number of vomiting episodes | 0.45 Number of vomiting episodes | Standard Deviation 1.76 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 delayed phase - Number of vomiting episodes | 0.35 Number of vomiting episodes | Standard Deviation 1.424 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 4 - Number of vomiting episodes | 0.14 Number of vomiting episodes | Standard Deviation 0.593 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 delayed phase - Number of vomiting episodes | 0.36 Number of vomiting episodes | Standard Deviation 1.507 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 5 - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.527 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 day 2 - Number of vomiting episodes | 0.19 Number of vomiting episodes | Standard Deviation 0.893 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 4 - Number of vomiting episodes | 0.11 Number of vomiting episodes | Standard Deviation 0.556 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 2 day 2 - Number of vomiting episodes | 0.10 Number of vomiting episodes | Standard Deviation 0.481 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 1 overall phase - Number of vomiting episodes | 0.55 Number of vomiting episodes | Standard Deviation 1.804 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 2 - Number of vomiting episodes | 0.18 Number of vomiting episodes | Standard Deviation 0.969 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Cycle 3 day 4 - Number of vomiting episodes | 0.17 Number of vomiting episodes | Standard Deviation 0.769 |
p-value: <0.0595% CI: [-0.13, 0.01]generalized linear model
p-value: <0.0595% CI: [-0.5, -0.12]generalized linear model
p-value: <0.0595% CI: [-0.21, -0.02]generalized linear model
p-value: <0.0595% CI: [-0.17, 0.04]generalized linear model
p-value: <0.0595% CI: [-0.16, 0.05]generalized linear model
p-value: <0.0595% CI: [-0.13, 0.05]generalized linear model
p-value: <0.0595% CI: [-0.6, -0.14]generalized linear model
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV
Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | Cycle 1 | 16.3 Doses of medication per cycle | Standard Deviation 68.53 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | Cycle 2 | 13.7 Doses of medication per cycle | Standard Deviation 57 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | Cycle 3 | 24.7 Doses of medication per cycle | Standard Deviation 99.48 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | Cycle 1 | 46.3 Doses of medication per cycle | Standard Deviation 343.13 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | Cycle 2 | 19.9 Doses of medication per cycle | Standard Deviation 70.87 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Daily Doses of Rescue Medication Administered for the Treatment of CINV | Cycle 3 | 17.5 Doses of medication per cycle | Standard Deviation 74.24 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work
Health economic endpoint, the number of days of absence from work, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | Cycle 1 | 3 Days | Standard Deviation 3.08 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | Cycle 2 | 1 Days | Standard Deviation 0 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | Cycle 3 | 2.4 Days | Standard Deviation 1.34 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | Cycle 1 | 5.7 Days | Standard Deviation 4.16 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | Cycle 2 | 4.3 Days | Standard Deviation 3.59 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work | Cycle 3 | 7.0 Days | Standard Deviation 2.83 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV
Health economic endpoint, the number of discontinuations of chemotherapy treatment due to CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | Cycle 1 | 1 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | Cycle 2 | 1 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | Cycle 3 | 0 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | Cycle 1 | 0 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | Cycle 2 | 1 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV | Cycle 3 | 0 Participants |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV
Health economic endpoint, the number of days with rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | cycle 1 | 0.5 Number of days | Standard Deviation 1.2 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | Cycle 2 | 0.4 Number of days | Standard Deviation 1.2 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | Cycle 3 | 0.5 Number of days | Standard Deviation 1.28 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | cycle 1 | 0.5 Number of days | Standard Deviation 1.13 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | Cycle 2 | 0.6 Number of days | Standard Deviation 1.26 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - Number of Days With Rescue Medication Administered for the Treatment of CINV | Cycle 3 | 0.5 Number of days | Standard Deviation 1.22 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV
Health economic endpoint, the average length of delay (in days) of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.
Time frame: At the start of Cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV | Cycle 2 | 0 Days | Standard Deviation 0 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV | Cycle 3 | 0 Days | Standard Deviation 0 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV | Cycle 2 | 7 Days | Standard Deviation 0 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Average Length of Delay of Chemotherapy Administration Due to CINV | Cycle 3 | 7.7 Days | Standard Deviation 1.15 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations
Health economic endpoint, the number of days of unplanned hospitalizations related to CINV, will be evaluated during the study cycles All hospitalizations will be summarized according to the department of hospitalization (type of ward)
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | Cycle 1 | 0 days of hospitalization | Standard Deviation 0.07 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | Cycle 2 | 0 days of hospitalization | Standard Deviation 0.23 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | Cycle 3 | 0 days of hospitalization | Standard Deviation 0 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | Cycle 1 | 0.1 days of hospitalization | Standard Deviation 0.75 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | Cycle 2 | 0 days of hospitalization | Standard Deviation 0.3 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations | Cycle 3 | 0 days of hospitalization | Standard Deviation 0.38 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV
Health economic endpoint, the number of delays of chemotherapy administration due to CINV, will be evaluated during the study cycles. Delays will be observed after the first administration of Cycle 1 for Cycles 2 and 3.
Time frame: At the start of cycles 2 and 3. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV | Cycle 3 | 0 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV | Cycle 2 | 0 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV | Cycle 2 | 2 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV | Cycle 3 | 3 Participants |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits
Health economic endpoint, the number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner), will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | Cycle 3 | 0 Number of outpatient visits | Standard Deviation 0 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | Cycle 1 | 0 Number of outpatient visits | Standard Deviation 0.07 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | Cycle 2 | 0 Number of outpatient visits | Standard Deviation 0.08 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | Cycle 1 | 0 Number of outpatient visits | Standard Deviation 0.16 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | Cycle 2 | 0 Number of outpatient visits | Standard Deviation 0.15 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits | Cycle 3 | 0 Number of outpatient visits | Standard Deviation 0 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags
Health economic endpoint, the number of re-hydration bags given for at least grade 2 vomiting (more details below), will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | Cycle 1 | 0 Number of bags | Standard Deviation 0 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | Cycle 2 | 0 Number of bags | Standard Deviation 0 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | Cycle 3 | 0 Number of bags | Standard Deviation 0 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | Cycle 1 | 0 Number of bags | Standard Deviation 0.2 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | Cycle 2 | 0 Number of bags | Standard Deviation 0.15 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags | Cycle 3 | 0 Number of bags | Standard Deviation 0 |
Secondary
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test
Health economic endpoint, the number of unplanned laboratory test including those at unplanned hospitalizations due to CINV, will be evaluated during the study cycles
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | Cycle 1 | 0 Number of unplanned tests | Standard Deviation 0.07 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | Cycle 2 | 0 Number of unplanned tests | Standard Deviation 0.15 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | Cycle 3 | 0 Number of unplanned tests | Standard Deviation 0 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | Cycle 1 | 0.1 Number of unplanned tests | Standard Deviation 0.46 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | Cycle 2 | 0 Number of unplanned tests | Standard Deviation 0.16 |
| Standard of care + Dexamethasone 8 mg | Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test | Cycle 3 | 0 Number of unplanned tests | Standard Deviation 0.23 |
Secondary
Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy
Analysis of the development of CINV as a dependent variable will be performed to identify additional potential risk factors of CINV thought to be increasing the risk of CINV in patients receiving MEC. The outcome measure is the development of CINV, defined as any occurrence of nausea or a vomiting episode. The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT).
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Population: The Full Analysis Set (FAS). Evaluation of the predictive role of potential risk factors within the FAS was analysed based on available data from 388 (NEPA: 189, SoC: 199) patients.~The number of patients included in the FAS population for each cycle depends on the availability of data on potential risk factors and the occurrence of nausea and/or vomiting. As the LOCF imputation method was applied for secondary endpoints, the number of participants analyzed in Cycle 1 remains lower.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | Cycle 1 - Any occurrence of nausea or a vomiting episode | 77 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | Cycle 2 - Any occurrence of nausea or a vomiting episode | 71 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | Cycle 3 - Any occurrence of nausea or a vomiting episode | 65 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | Cycle 1 - Any occurrence of nausea or a vomiting episode | 97 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | Cycle 2 - Any occurrence of nausea or a vomiting episode | 90 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Predictive Role of Potential Risk Factors in the Development of CINV Over Three Cycles of Chemotherapy | Cycle 3 - Any occurrence of nausea or a vomiting episode | 86 Participants |
Comparison: The hypothesis states that the potential risk factor of \< 7 h of sleep the night before chemotherapy increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.41295% CI: [0.68, 1.17]generalized linear model
Comparison: The hypothesis states that the potential risk factor of History of any nausea and vomiting such as motion sickness, vestibular dysfunction, … increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.59295% CI: [0.71, 1.8]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Anticipatory nausea and/or vomiting increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.45895% CI: [0.8, 1.65]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Anxiety over the past 24hrs increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.66395% CI: [0.75, 1.56]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Alcohol intake (\>= 10 units per week vs \< 10 units per week) increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratio.p-value: 0.69195% CI: [0.46, 1.68]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Gender increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.03795% CI: [1.02, 2.14]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Fatigue experience (symptom) increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.51495% CI: [0.84, 1.42]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Smoking status increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.12795% CI: [0.52, 1.08]generalized linear model
Comparison: The hypothesis states that the potential risk factor of Weight increases the risk of CINV, defined as any occurrence of nausea or a vomiting episode.~This potential risk factor was included in the generalized linear model as covariate, and its effect was evaluated using odds ratios.p-value: 0.01495% CI: [0.77, 0.97]generalized linear model
Secondary
Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy
Probability of: * No emetic episode during the acute, delayed, and overall phase and daily in each cycle * No rescue medication during the acute, delayed, and overall phase and daily in each cycle * No significant nausea (maximum MAT scale = 2) during the acute, delayed, and overall phase and daily in each cycle; * No nausea (MAT scale = 0) during the acute, delayed, and overall phase and daily in each cycle; * Complete protection (no emetic episode, no rescue medication, and no significant nausea) during the acute, delayed, and overall phase and daily in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles. The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a per cycle CINV Indicators between the treatment arms.
Time frame: At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Population: The model-based statistics of generalized linear model were used to calculate the difference in the probability to experience a per cycle CINV Indicators between the treatment arms. The probability for the Standard of Care arm is reported as the crude probability in generic cycle. The probability for the NEPA arm was calculated as the derived probability based on model odds ratio, with the model including relevant covariates.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 2 | 0.893 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 4 | 0.847 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 5 | 0.981 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 5 | 0.865 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 3 | 0.905 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - overall phase | 0.775 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 3 | 0.968 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - acute phase | 0.777 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 4 | 0.905 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - delayed phase | 0.677 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - overall phase | 0.954 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 2 | 0.779 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 5 | 0.910 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 3 | 0.749 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 2 | 0.981 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 4 | 0.746 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - overall phase | 0.824 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 5 | 0.797 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - acute phase | 0.896 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - overall phase | 0.637 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - acute phase | 0.868 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - acute phase | 0.832 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 4 | 0.977 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - delayed phase | 0.755 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - delayed phase | 0.815 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 2 | 0.822 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - delayed phase | 0.848 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 3 | 0.816 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 2 | 0.872 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 4 | 0.821 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic episode - delayed phase | 0.966 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 5 | 0.834 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 3 | 0.848 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - overall phase | 0.718 Probability |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic episode - acute phase | 0.983 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - overall phase | 0.624 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic episode - acute phase | 0.951 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic episode - delayed phase | 0.881 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 2 | 0.938 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 3 | 0.927 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 4 | 0.938 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - Day 5 | 0.963 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No emetic - overall phase | 0.867 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - acute phase | 0.897 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - delayed phase | 0.785 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 2 | 0.880 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 3 | 0.872 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 4 | 0.877 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - Day 5 | 0.915 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No rescue medication - overall phase | 0.765 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - acute phase | 0.856 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - delayed phase | 0.755 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 2 | 0.817 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 3 | 0.790 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 4 | 0.803 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - Day 5 | 0.832 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No significant nausea - overall phase | 0.727 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - acute phase | 0.744 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - delayed phase | 0.576 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 2 | 0.682 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 3 | 0.655 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 4 | 0.652 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - Day 5 | 0.703 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | No nausea - overall phase | 0.549 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - acute phase | 0.798 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - delayed phase | 0.653 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 2 | 0.765 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 3 | 0.740 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 4 | 0.762 Probability |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Probability of Acute (0 to 24 Hours), Delayed (>24 to 120 Hours), and Overall (0-120 Hours) CINV Indicators in Each Cycle of Chemotherapy | Complete protection - Day 5 | 0.802 Probability |
Secondary
Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events
An overall summary of adverse events (AE) will be presented, including the percentage of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE leading to chemotherapy dose reductions | 3.1 percentage of patients |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any serious TEAE | 11.2 percentage of patients |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE related to a study drug | 18.9 percentage of patients |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any severe TEAE | 13.3 percentage of patients |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE leading to treatment discontinuation | 2.6 percentage of patients |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with on treatment death due to TEAE | 1.0 percentage of patients |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE | 76.5 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with on treatment death due to TEAE | 1.0 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE | 73.2 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE related to a study drug | 18.5 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE leading to chemotherapy dose reductions | 5.4 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any TEAE leading to treatment discontinuation | 3.4 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any serious TEAE | 11.2 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - Percentage of Participants With Adverse Events | Patients with any severe TEAE | 15.6 percentage of patients |
Secondary
Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE)
An overall summary of adverse events (AE) will be presented, including the frequency of patients with: * Any treatment-emergent adverse event * Any treatment-emergent adverse event related to a study drug * Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions * Any treatment-emergent serious adverse event All AEs will be summarized by their: * Severity * Seriousness * Relationship to a drug
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE leading to chemotherapy dose reductions | 6 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any serious TEAE | 22 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE | 150 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any severe TEAE | 26 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE leading to treatment discontinuation | 5 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with on treatment death due to TEAE | 2 Participants |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE related to a study drug | 37 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with on treatment death due to TEAE | 2 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE related to a study drug | 38 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE | 150 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE leading to chemotherapy dose reductions | 11 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any TEAE leading to treatment discontinuation | 7 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any serious TEAE | 23 Participants |
| Standard of care + Dexamethasone 8 mg | Evaluation of the Safety Profile of the Antiemetic Drug Over Three Cycles of Chemotherapy - the Frequency of Adverse Events (AE) | Patients with any severe TEAE | 32 Participants |
Secondary
Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy
Evaluation of the effect of CINV on daily activities and quality of life that will be measured by using the Functional Living Index-Emesis (FLIE) questionnaire, a validated, nausea and vomiting specific, patient-reported outcome instrument. The Functional Living Index-Emesis (FLIE) has 18 questions. These questions are divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). The minimum score for any question is 0 and the maximum score is 100. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. The model-based statistics of generalized linear model were used to calculate the difference in the score per cycle between the treatment arms.
Time frame: At the end of chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Population: Full analysis set. Patients with evaluable data in cycle 1 and eligible for imputation, using last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | After cycle 1 - FLIE score | 115.14 FLIE score | Standard Deviation 17.152 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | After cycle 2 - FLIE score | 115.78 FLIE score | Standard Deviation 18.022 |
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | After cycle 3 - FLIE score | 114.74 FLIE score | Standard Deviation 19.356 |
| Standard of care + Dexamethasone 8 mg | Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | After cycle 1 - FLIE score | 111.10 FLIE score | Standard Deviation 21.134 |
| Standard of care + Dexamethasone 8 mg | Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | After cycle 2 - FLIE score | 112.10 FLIE score | Standard Deviation 19.919 |
| Standard of care + Dexamethasone 8 mg | Exploration of the Effect of CINV on Daily Activities and Quality of Life in Patients Receiving Moderately-emetogenic Chemotherapy Over Three Cycles of Chemotherapy | After cycle 3 - FLIE score | 111.24 FLIE score | Standard Deviation 21.772 |
p-value: <0.0595% CI: [0.05, 6.96]generalized linear model
Secondary
Number of Participants With Death Due to Adverse Events
The frequency of on treatment deaths due to adverse events (AE) will be presented.
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Number of Participants With Death Due to Adverse Events | 2 Participants |
| Standard of care + Dexamethasone 8 mg | Number of Participants With Death Due to Adverse Events | 2 Participants |
Secondary
Number of Participants With Discontinuations Due to Adverse Events
The frequency of discontinuations due to adverse events (AE) will be presented.
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Number of Participants With Discontinuations Due to Adverse Events | 5 Participants |
| Standard of care + Dexamethasone 8 mg | Number of Participants With Discontinuations Due to Adverse Events | 7 Participants |
Secondary
Percentage of Participants With Death Due to Adverse Events
The percentage of patients with on treatment death due to adverse events (AE) will be presented. All AEs leading to on treatment death will be summarized by their: * Severity * Seriousness * Relationship to a drug
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Percentage of Participants With Death Due to Adverse Events | 1.0 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Percentage of Participants With Death Due to Adverse Events | 1.0 percentage of patients |
Secondary
Percentage of Participants With Discontinuations Due to Adverse Events
The percentage of patients with discontinuations due to adverse events (AE) will be presented.
Time frame: At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg | Percentage of Participants With Discontinuations Due to Adverse Events | 2.6 percentage of patients |
| Standard of care + Dexamethasone 8 mg | Percentage of Participants With Discontinuations Due to Adverse Events | 3.4 percentage of patients |