Trial Outcomes & Findings for Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer (NCT NCT03367572)
NCT ID: NCT03367572
Last Updated: 2025-09-25
Results Overview
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1363 participants
Primary outcome timeframe
Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)
Results posted on
2025-09-25
Participant Flow
1363 subjects were enrolled. CYCLE 1 which is the First Chemotherapy Cycle (excluded 796 \[5 registration errors, 41 no four-day home record, 750 did not have average score of 3 or better\]) CYCLE 2 which is the Second Chemotherapy Cycle (excluded 250 \[subject decided not to continue on cycle 2\]). 317 subjects are available for randomization. 310 subjects were actually randomized.
Participant milestones
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Total Subjects Randomized
STARTED
|
92
|
113
|
112
|
|
Total Subjects Randomized
COMPLETED
|
91
|
110
|
109
|
|
Total Subjects Randomized
NOT COMPLETED
|
1
|
3
|
3
|
|
Second Chemotherapy Cycle (Cycle 2)
STARTED
|
91
|
110
|
109
|
|
Second Chemotherapy Cycle (Cycle 2)
COMPLETED
|
85
|
108
|
100
|
|
Second Chemotherapy Cycle (Cycle 2)
NOT COMPLETED
|
6
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
50.0 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
50.2 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
50.7 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
310 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
280 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
245 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Marital Status
Married / Long Term
|
66 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
233 Participants
n=7 Participants
|
|
Marital Status
Divorced
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Marital Status
Separated
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Marital Status
Single
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Education
College or Grad School
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
|
Education
High School or Less
|
71 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
240 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
Cycle 1
|
4.51 units on a scale
Standard Error 0.155
|
4.70 units on a scale
Standard Error 0.141
|
4.93 units on a scale
Standard Error 0.141
|
|
Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
Cycle 2
|
3.22 units on a scale
Standard Error 0.164
|
2.68 units on a scale
Standard Error 0.147
|
2.37 units on a scale
Standard Error 0.152
|
PRIMARY outcome
Timeframe: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
Cycle 1
|
2.40 units on a scale
Standard Error 0.120
|
2.58 units on a scale
Standard Error 0.109
|
2.50 units on a scale
Standard Error 0.109
|
|
Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
Cycle 2
|
1.90 units on a scale
Standard Error 0.101
|
1.62 units on a scale
Standard Error 0.090
|
1.45 units on a scale
Standard Error 0.093
|
SECONDARY outcome
Timeframe: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)Will be measured on a 7-point scale anchored by "1:not at all nauseated" and "7:extremely nauseated". Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 and 16 assessment points for Cycle 2. This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean.
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared.
Cycle 1
|
4.51 units on a scale
Standard Error 0.155
|
4.70 units on a scale
Standard Error 0.141
|
4.93 units on a scale
Standard Error 0.141
|
|
The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared.
Cycle 2
|
3.22 units on a scale
Standard Error 0.164
|
2.68 units on a scale
Standard Error 0.147
|
2.37 units on a scale
Standard Error 0.152
|
SECONDARY outcome
Timeframe: Vomiting measured at Cycle 1 Chemotherapy (Yes/No on Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (Yes/No on Days 1,2,3,4)The response variable will be Any VOMITING (yes/no) after Cycle 2 Chemotherapy, treatment arm as the main factor, and Any Vomiting after Cycle 1 as a covariate. Estimation will be performed using maximum likelihood assuming a binomial distribution and logit link. The same group of contrasts described in the Primary Aim analysis will be estimated and tested, with a significance level of 0.025 to adjust for multiple tests.
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1.
Yes
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1.
No
|
79 Participants
|
103 Participants
|
98 Participants
|
|
Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1.
Unknown
|
5 Participants
|
3 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 2 ChemotherapyGrouping of Chemotherapy Regimens at Cycle 2
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Regimens: Chemotherapy Regimens at Cycle 2
Unknown
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Regimens: Chemotherapy Regimens at Cycle 2
Anthracycline based
|
54 Participants
|
68 Participants
|
55 Participants
|
|
Regimens: Chemotherapy Regimens at Cycle 2
Taxane based
|
19 Participants
|
22 Participants
|
22 Participants
|
|
Regimens: Chemotherapy Regimens at Cycle 2
Platinum based
|
14 Participants
|
16 Participants
|
27 Participants
|
|
Regimens: Chemotherapy Regimens at Cycle 2
Others
|
0 Participants
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 2 ChemotherapyEmetogenic Potential: The percentage of risk of vomiting based on given chemotherapy agents. Reference: https://pubmed.ncbi.nlm.nih.gov/38129530/
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Emetogenic Potential
High ( >=90 % risk of vomiting )
|
54 Participants
|
68 Participants
|
55 Participants
|
|
Emetogenic Potential
Moderate ( 30 - 90 % risk of vomiting )
|
33 Participants
|
40 Participants
|
52 Participants
|
|
Emetogenic Potential
Unknown
|
4 Participants
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 ChemotherapyRecord of any vomiting (Yes/No) during Cycle 1 of Chemotherapy on Days 1, 2, 3, 4
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Vomiting at Cycle 1 of Chemotherapy
Yes
|
12 Participants
|
18 Participants
|
19 Participants
|
|
Vomiting at Cycle 1 of Chemotherapy
No
|
79 Participants
|
92 Participants
|
90 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 2 ChemotherapyRecord of any vomiting (Yes/No) during Cycle 2 of Chemotherapy on Days 1, 2, 3, 4
Outcome measures
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 Participants
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 Participants
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Vomiting at Cycle 2 of Chemotherapy
Yes
|
7 Participants
|
4 Participants
|
2 Participants
|
|
Vomiting at Cycle 2 of Chemotherapy
No
|
79 Participants
|
103 Participants
|
98 Participants
|
|
Vomiting at Cycle 2 of Chemotherapy
Unknown
|
5 Participants
|
3 Participants
|
9 Participants
|
Adverse Events
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 participants at risk
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 participants at risk
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 participants at risk
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
1.8%
2/109 • Number of events 2 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders, other specify
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
General disorders
Pain
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
Other adverse events
| Measure |
Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone
n=91 participants at risk
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)
n=110 participants at risk
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Placebo: Given PO
Prochlorperazine: Given PO
Quality-of-Life Assessment: Ancillary studies
|
Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo)
n=109 participants at risk
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Dexamethasone: Given PO
Laboratory Biomarker Analysis: Correlative studies
Netupitant/Palonosetron Hydrochloride: Given PO
Olanzapine: Given PO
Placebo: Given PO
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|
|
Investigations
Headache
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
General disorders
Restlessness
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
4.6%
5/109 • Number of events 5 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
General disorders
Fatigue
|
3.3%
3/91 • Number of events 3 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
9.1%
10/110 • Number of events 10 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
5.5%
6/109 • Number of events 6 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
3/91 • Number of events 3 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
1.8%
2/110 • Number of events 2 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
1.8%
2/109 • Number of events 2 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Anxiety
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
3.6%
4/110 • Number of events 4 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
1.8%
2/110 • Number of events 2 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
1.8%
2/109 • Number of events 2 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
General disorders
Lethargy
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
General disorders
Dry Mouth
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Hiccups
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Tremor
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.92%
1/109 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Seizure
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/91 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.91%
1/110 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
|
Psychiatric disorders
Agitation
|
1.1%
1/91 • Number of events 1 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/110 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
0.00%
0/109 • The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.
|
Additional Information
Luke J. Peppone, PhD, MPH
University of Rochester Medical Center
Phone: 585-275-7827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place