Trial Outcomes & Findings for Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (NCT NCT04817189)
NCT ID: NCT04817189
Last Updated: 2025-12-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
414 participants
Primary outcome timeframe
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).
Results posted on
2025-12-02
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
208
|
|
Overall Study
Full Analysis Set (FAS) population
|
196
|
205
|
|
Overall Study
COMPLETED
|
154
|
163
|
|
Overall Study
NOT COMPLETED
|
52
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NEPA (300mg Netupitant/0.5mg Palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
|
Standard of Care + Dexamethasone 8 mg
n=205 Participants
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)
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 year
STANDARD_DEVIATION 11.8 • n=196 Participants
|
62.7 year
STANDARD_DEVIATION 11.3 • n=205 Participants
|
62.7 year
STANDARD_DEVIATION 11.5 • n=401 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=196 Participants
|
87 Participants
n=205 Participants
|
180 Participants
n=401 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=196 Participants
|
118 Participants
n=205 Participants
|
221 Participants
n=401 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
weight
|
73.28 kg
STANDARD_DEVIATION 16.001 • n=196 Participants
|
74.78 kg
STANDARD_DEVIATION 17.285 • n=205 Participants
|
74.05 kg
STANDARD_DEVIATION 16.666 • n=401 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=189 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=199 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
The Probability of Complete Responses Over Three Cycles of Chemotherapy After the Start of the MEC Administration
|
0.810 Probability of complete response
|
0.718 Probability of complete response
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=189 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=199 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
0.963 Probability
|
|
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
|
0.880 Probability
|
|
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
|
0.872 Probability
|
|
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
|
0.877 Probability
|
|
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
|
0.765 Probability
|
|
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
|
0.755 Probability
|
|
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
|
0.817 Probability
|
|
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
|
0.790 Probability
|
|
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
|
0.803 Probability
|
|
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
|
0.652 Probability
|
|
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
|
0.549 Probability
|
|
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
|
0.951 Probability
|
|
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
|
0.881 Probability
|
|
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
|
0.938 Probability
|
|
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
|
0.927 Probability
|
|
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
|
0.938 Probability
|
|
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
|
0.867 Probability
|
|
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
|
0.897 Probability
|
|
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
|
0.785 Probability
|
|
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
|
0.915 Probability
|
|
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
|
0.856 Probability
|
|
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
|
0.576 Probability
|
|
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
|
0.832 Probability
|
|
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
|
0.727 Probability
|
|
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
|
0.744 Probability
|
|
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
|
0.682 Probability
|
|
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
|
0.655 Probability
|
|
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
|
0.703 Probability
|
|
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
|
0.798 Probability
|
|
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
|
0.653 Probability
|
|
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
|
0.765 Probability
|
|
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
|
0.740 Probability
|
|
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
|
0.762 Probability
|
|
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
|
0.802 Probability
|
|
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
|
0.624 Probability
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=189 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=199 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
97 Participants
|
|
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
|
90 Participants
|
|
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
|
86 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
32 Participants
|
|
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
|
38 Participants
|
|
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
|
150 Participants
|
|
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
|
11 Participants
|
|
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
|
7 Participants
|
|
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
|
23 Participants
|
|
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
|
2 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
5.4 percentage of patients
|
|
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
|
15.6 percentage of patients
|
|
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
|
73.2 percentage of patients
|
|
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
|
18.5 percentage of patients
|
|
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
|
3.4 percentage of patients
|
|
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
|
11.2 percentage of patients
|
|
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
|
1.0 percentage of patients
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Number of Participants With Discontinuations Due to Adverse Events
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Percentage of Participants With Discontinuations Due to Adverse Events
|
2.6 percentage of patients
|
3.4 percentage of patients
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Number of Participants With Death Due to Adverse Events
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Percentage of Participants With Death Due to Adverse Events
|
1.0 percentage of patients
|
1.0 percentage of patients
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=189 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=199 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
111.10 FLIE score
Standard Deviation 21.134
|
|
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
|
112.10 FLIE score
Standard Deviation 19.919
|
|
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
|
111.24 FLIE score
Standard Deviation 21.772
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
0.5 Number of days
Standard Deviation 1.22
|
|
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 1.20
|
0.5 Number of days
Standard Deviation 1.13
|
|
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 1.20
|
0.6 Number of days
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
46.3 Doses of medication per cycle
Standard Deviation 343.13
|
|
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 57.0
|
19.9 Doses of medication per cycle
Standard Deviation 70.87
|
|
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
|
17.5 Doses of medication per cycle
Standard Deviation 74.24
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags
Cycle 1
|
0 Number of bags
Standard Deviation 0.00
|
0 Number of bags
Standard Deviation 0.20
|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags
Cycle 2
|
0 Number of bags
Standard Deviation 0.00
|
0 Number of bags
Standard Deviation 0.15
|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Re-hydration Bags
Cycle 3
|
0 Number of bags
Standard Deviation 0.00
|
0 Number of bags
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
0.1 days of hospitalization
Standard Deviation 0.75
|
|
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
|
0 days of hospitalization
Standard Deviation 0.30
|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Days of Unplanned Hospitalisations
Cycle 3
|
0 days of hospitalization
Standard Deviation 0.00
|
0 days of hospitalization
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
0 Number of outpatient visits
Standard Deviation 0.16
|
|
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
|
0 Number of outpatient visits
Standard Deviation 0.15
|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Outpatient Physician Visits
Cycle 3
|
0 Number of outpatient visits
Standard Deviation 0.00
|
0 Number of outpatient visits
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
0.1 Number of unplanned tests
Standard Deviation 0.46
|
|
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
|
0 Number of unplanned tests
Standard Deviation 0.16
|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Unplanned Laboratory Test
Cycle 3
|
0 Number of unplanned tests
Standard Deviation 0.00
|
0 Number of unplanned tests
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV
Cycle 1
|
1 Participants
|
0 Participants
|
|
Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV
Cycle 2
|
1 Participants
|
1 Participants
|
|
Evaluation of Resource Utilization and Health Economic Outcome - Discontinuation of Chemotherapy Treatment Due to CINV
Cycle 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV
Cycle 2
|
0 Participants
|
2 Participants
|
|
Evaluation of Resource Utilization and Health Economic Outcome - the Number of Delays of Chemotherapy Administration Due to CINV
Cycle 3
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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
|
7 Days
Standard Deviation 0.00
|
|
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
|
7.7 Days
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=205 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work
Cycle 1
|
3 Days
Standard Deviation 3.08
|
5.7 Days
Standard Deviation 4.16
|
|
Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work
Cycle 2
|
1 Days
Standard Deviation 0.00
|
4.3 Days
Standard Deviation 3.59
|
|
Evaluation of Resource Utilization and Health Economic Outcome - Days of Absence From Work
Cycle 3
|
2.4 Days
Standard Deviation 1.34
|
7.0 Days
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=189 Participants
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.
NEPA (300mg netupitant/0.5mg palonosetron): Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
Standard of care + Dexamethasone 8 mg
n=199 Participants
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)
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): Standard of care will be administered on Day 1 of each cycle.
Dexamethasone, 8 mg (oral) or equivalent IV dose: Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
|
|---|---|---|
|
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 0.300
|
0.09 Number of vomiting episodes
Standard Deviation 0.494
|
|
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
|
0.10 Number of vomiting episodes
Standard Deviation 0.508
|
|
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
|
0.11 Number of vomiting episodes
Standard Deviation 0.601
|
|
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
|
0.46 Number of vomiting episodes
Standard Deviation 1.579
|
|
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 0.440
|
0.35 Number of vomiting episodes
Standard Deviation 1.424
|
|
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
|
0.36 Number of vomiting episodes
Standard Deviation 1.507
|
|
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 0.230
|
0.19 Number of vomiting episodes
Standard Deviation 0.893
|
|
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
|
0.10 Number of vomiting episodes
Standard Deviation 0.481
|
|
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
|
0.18 Number of vomiting episodes
Standard Deviation 0.969
|
|
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
|
0.20 Number of vomiting episodes
Standard Deviation 0.825
|
|
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 0.690
|
0.11 Number of vomiting episodes
Standard Deviation 0.579
|
|
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
|
0.17 Number of vomiting episodes
Standard Deviation 0.777
|
|
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
|
0.14 Number of vomiting episodes
Standard Deviation 0.593
|
|
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 0.670
|
0.11 Number of vomiting episodes
Standard Deviation 0.556
|
|
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
|
0.17 Number of vomiting episodes
Standard Deviation 0.769
|
|
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
|
0.07 Number of vomiting episodes
Standard Deviation 0.438
|
|
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 0.480
|
0.10 Number of vomiting episodes
Standard Deviation 0.527
|
|
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
|
0.15 Number of vomiting episodes
Standard Deviation 0.792
|
|
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
|
0.55 Number of vomiting episodes
Standard Deviation 1.804
|
|
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
|
0.45 Number of vomiting episodes
Standard Deviation 1.760
|
|
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
|
0.47 Number of vomiting episodes
Standard Deviation 1.909
|
Adverse Events
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
Serious events: 22 serious events
Other events: 150 other events
Deaths: 2 deaths
Standard of care + Dexamethasone 8 mg
Serious events: 23 serious events
Other events: 150 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 participants at risk
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.
|
Standard of care + Dexamethasone 8 mg
n=205 participants at risk
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)
|
|---|---|---|
|
Vascular disorders
Thrombosis
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Blood and lymphatic system disorders
neutropenia
|
3.1%
6/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.4%
5/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.4%
5/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
1.5%
3/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Death
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Pyrexia
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
General physical health deterioration
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Chills
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Pain
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Hepatobiliary disorders
Cholangitis
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Hepatobiliary disorders
Hyper-transaminasaemia
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Immune system disorders
Drug hypersensitivity
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Infection
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
COVID-19
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Infections and infestations
Septic shock
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Investigations
Platelet count decreased
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Surgical and medical procedures
Antibiotic therapy
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Vascular disorders
Hypertension
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.00%
0/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
Other adverse events
| Measure |
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
n=196 participants at risk
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.
|
Standard of care + Dexamethasone 8 mg
n=205 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
4.6%
9/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.9%
6/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
8/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.9%
6/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
4.9%
10/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
6/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Dysphagia
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.9%
6/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Eructation
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Constipation
|
20.9%
41/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
14.1%
29/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
19/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
12.2%
25/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
15/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
8.3%
17/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.1%
8/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.9%
8/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.4%
40/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
23.4%
48/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Abdominal distension Flatulence
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Fatigue
|
27.6%
54/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
22.4%
46/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Asthenia
|
12.8%
25/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
10.2%
21/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
General physical health deterioration
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
5.9%
12/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Pain
|
3.1%
6/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Pyrexia
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Oedema peripheral
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.9%
8/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Chest pain
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
General disorders
Chills
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.7%
23/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
14.6%
30/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
1.5%
3/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
11/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
7.8%
16/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
7/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
1.5%
3/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
3.1%
6/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Paraesthesia
|
16.8%
33/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
12.7%
26/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Dizziness
|
12.2%
24/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
7.3%
15/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
15/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
9.8%
20/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Headache
|
9.2%
18/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
7.3%
15/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
11/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
9.8%
20/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Neurotoxicity
|
5.1%
10/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.9%
8/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Dysgeusia
|
4.1%
8/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Polyneuropathy
|
3.1%
6/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Somnolence
|
3.6%
7/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.4%
5/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Cold dysaesthesia
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
1.5%
3/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Nervous system disorders
Taste disorder
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Psychiatric disorders
Insomnia
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.9%
8/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Psychiatric disorders
Restlessness
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.1%
10/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.9%
8/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
4/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.9%
6/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.49%
1/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.6%
9/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
5.9%
12/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
3.4%
7/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
9/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
0.98%
2/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
3/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.4%
5/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.51%
1/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.4%
5/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Vascular disorders
Peripheral coldness
|
2.6%
5/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.0%
4/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
|
Vascular disorders
Hypotension
|
1.0%
2/196 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
2.4%
5/205 • Adverse event data were collected from the date of informed consent to Day 5 of Cycle 3 (approximately 6.3 weeks). The longest time period was 17.6 weeks. The time differes per the days of the chemotherapy cycle.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60