Trial Outcomes & Findings for Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy (NCT NCT02116530)
NCT ID: NCT02116530
Last Updated: 2025-01-28
Results Overview
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
401 participants
Primary outcome timeframe
0 to 120 hours after chemotherapy
Results posted on
2025-01-28
Participant Flow
Four-hundred and one (401) participants were enrolled from 46 academic or community practice institutions in the United States between August 2014 and March 2015.
There were eighteen participants withdrew consent (8 Olanzapine; 10 Placebo); and three participants had major violations (2 Olanzapine; 1 Placebo). All of these 21 participants were excluded from all analyses.
Participant milestones
| Measure |
Olanzapine
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
188
|
|
Overall Study
COMPLETED
|
183
|
184
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
Olanzapine
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Other Medical Problems
|
2
|
2
|
Baseline Characteristics
Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy
Baseline characteristics by cohort
| Measure |
Olanzapine
n=192 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=188 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
56 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
139 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
172 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
192 participants
n=5 Participants
|
188 participants
n=7 Participants
|
380 participants
n=5 Participants
|
|
5-hydroxytryptamine type 3 receptor antagonist
Palonosetron
|
145 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
5-hydroxytryptamine type 3 receptor antagonist
Ondansetron
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
5-hydroxytryptamine type 3 receptor antagonist
Granisetron
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Chemotherapy regimen
Cisplatin-containing regimen
|
71 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Chemotherapy regimen
Anthracyline and cyclophosphamide
|
121 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Primary site of disease
Breast
|
120 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Primary site of disease
Lung
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Primary site of disease
Other
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0=Asymptomatic and fully active
|
149 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1=Symptomatic and fully ambulatory
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2=Symptomatic, <50% in bed during the day
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Not assessed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 120 hours after chemotherapyPopulation: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.
Outcome measures
| Measure |
Olanzapine
n=183 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=181 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Proportion of Patients With no Nausea
0-24 hours after chemotherapy
|
73.8 percentage of participants
|
45.3 percentage of participants
|
|
Proportion of Patients With no Nausea
25-120 hours after chemotherapy
|
42.4 percentage of participants
|
25.4 percentage of participants
|
|
Proportion of Patients With no Nausea
0-120 hours after chemotherapy
|
37.3 percentage of participants
|
21.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 2 to Day 6 after chemotherapyPopulation: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data at each time point.
Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Outcome measures
| Measure |
Olanzapine
n=190 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=188 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Median Nausea Scores
Baseline
|
0 units on a scale
Interval 0.0 to 7.0
|
0 units on a scale
Interval 0.0 to 9.0
|
|
Median Nausea Scores
Day 2
|
0 units on a scale
Interval 0.0 to 10.0
|
1 units on a scale
Interval 0.0 to 10.0
|
|
Median Nausea Scores
Day 3
|
0 units on a scale
Interval 0.0 to 9.0
|
1 units on a scale
Interval 0.0 to 10.0
|
|
Median Nausea Scores
Day 4
|
0 units on a scale
Interval 0.0 to 8.0
|
1 units on a scale
Interval 0.0 to 9.0
|
|
Median Nausea Scores
Day 5
|
0 units on a scale
Interval 0.0 to 10.0
|
1 units on a scale
Interval 0.0 to 10.0
|
|
Median Nausea Scores
Day 6
|
0 units on a scale
Interval 0.0 to 9.0
|
1 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 0 to 120 hours after chemotherapyPopulation: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had data on emetic and use of rescue medication questions.
Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Outcome measures
| Measure |
Olanzapine
n=182 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=181 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Proportion of Patients With Complete Response
0-24 hours after chemotherapy
|
85.7 percentage of participants
|
64.6 percentage of participants
|
|
Proportion of Patients With Complete Response
25-120 hours after chemotherapy
|
66.9 percentage of participants
|
52.4 percentage of participants
|
|
Proportion of Patients With Complete Response
0-120 hours after chemotherapy
|
63.6 percentage of participants
|
40.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and day 2 to 6 days after chemotherapyPopulation: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had toxicities data at each time point.
Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Outcome measures
| Measure |
Olanzapine
n=190 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=188 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 5 Undesired Sedation
|
1.2 units on a scale
Standard Deviation 2.1
|
1.2 units on a scale
Standard Deviation 2.1
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 4 Appetite Increase
|
1.0 units on a scale
Standard Deviation 1.8
|
0.7 units on a scale
Standard Deviation 1.7
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Baseline Undesired Sedation
|
0.4 units on a scale
Standard Deviation 1.2
|
0.5 units on a scale
Standard Deviation 1.5
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 2 Undesired Sedation
|
2.3 units on a scale
Standard Deviation 3.2
|
1.2 units on a scale
Standard Deviation 2.2
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 3 Undesired Sedation
|
1.6 units on a scale
Standard Deviation 2.5
|
1.4 units on a scale
Standard Deviation 2.3
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 4 Undesired Sedation
|
1.5 units on a scale
Standard Deviation 2.3
|
1.4 units on a scale
Standard Deviation 2.3
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 6 Undesired Sedation
|
0.9 units on a scale
Standard Deviation 1.8
|
1.3 units on a scale
Standard Deviation 2.2
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Baseline Appetite Increase
|
0.6 units on a scale
Standard Deviation 1.7
|
0.3 units on a scale
Standard Deviation 0.9
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 2 Appetite Increase
|
0.7 units on a scale
Standard Deviation 1.6
|
0.5 units on a scale
Standard Deviation 1.5
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 3 Appetite Increase
|
0.7 units on a scale
Standard Deviation 1.5
|
0.6 units on a scale
Standard Deviation 1.7
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 5 Appetite Increase
|
1.0 units on a scale
Standard Deviation 1.8
|
0.7 units on a scale
Standard Deviation 1.7
|
|
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Day 6 Appetite Increase
|
1.1 units on a scale
Standard Deviation 2.0
|
0.7 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Day 2 to Day 6 after chemotherapyPopulation: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had rescue medication data at each time point.
Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.
Outcome measures
| Measure |
Olanzapine
n=182 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=181 Participants
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Frequency of Rescue Medication
Day 5 · Twice
|
5 Participants
|
7 Participants
|
|
Frequency of Rescue Medication
Day 2 · None
|
156 Participants
|
117 Participants
|
|
Frequency of Rescue Medication
Day 2 · Once
|
21 Participants
|
35 Participants
|
|
Frequency of Rescue Medication
Day 2 · Twice
|
3 Participants
|
19 Participants
|
|
Frequency of Rescue Medication
Day 2 · More than twice
|
2 Participants
|
10 Participants
|
|
Frequency of Rescue Medication
Day 3 · None
|
158 Participants
|
124 Participants
|
|
Frequency of Rescue Medication
Day 3 · Once
|
11 Participants
|
24 Participants
|
|
Frequency of Rescue Medication
Day 3 · Twice
|
7 Participants
|
20 Participants
|
|
Frequency of Rescue Medication
Day 3 · More than twice
|
4 Participants
|
10 Participants
|
|
Frequency of Rescue Medication
Day 4 · None
|
141 Participants
|
124 Participants
|
|
Frequency of Rescue Medication
Day 4 · Once
|
16 Participants
|
24 Participants
|
|
Frequency of Rescue Medication
Day 4 · Twice
|
10 Participants
|
17 Participants
|
|
Frequency of Rescue Medication
Day 4 · More than twice
|
3 Participants
|
11 Participants
|
|
Frequency of Rescue Medication
Day 5 · None
|
145 Participants
|
131 Participants
|
|
Frequency of Rescue Medication
Day 5 · Once
|
19 Participants
|
23 Participants
|
|
Frequency of Rescue Medication
Day 5 · More than twice
|
4 Participants
|
10 Participants
|
|
Frequency of Rescue Medication
Day 6 · None
|
143 Participants
|
130 Participants
|
|
Frequency of Rescue Medication
Day 6 · Once
|
12 Participants
|
16 Participants
|
|
Frequency of Rescue Medication
Day 6 · Twice
|
12 Participants
|
11 Participants
|
|
Frequency of Rescue Medication
Day 6 · More than twice
|
4 Participants
|
14 Participants
|
Adverse Events
Olanzapine
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olanzapine
n=188 participants at risk
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=185 participants at risk
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
1.1%
2/188 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Investigations
White blood cell decreased
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Vascular disorders
Thromboembolic event
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
Other adverse events
| Measure |
Olanzapine
n=188 participants at risk
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)
|
Placebo
n=185 participants at risk
Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 3 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Eye disorders
Blurred vision
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Eye disorders
Dry eye
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
1/188 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Bloating
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.1%
2/185 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
4/188 • Number of events 5 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.1%
2/185 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.1%
2/185 • Number of events 3 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
3/188 • Number of events 4 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
3.2%
6/185 • Number of events 8 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.1%
2/188 • Number of events 3 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.1%
2/188 • Number of events 4 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Nausea
|
2.7%
5/188 • Number of events 8 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
4.9%
9/185 • Number of events 17 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.1%
2/185 • Number of events 4 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
General disorders
Edema limbs
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
General disorders
Fatigue
|
5.9%
11/188 • Number of events 13 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
4.9%
9/185 • Number of events 12 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.53%
1/188 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Investigations
Platelet count decreased
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Investigations
White blood cell decreased
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
2.2%
4/185 • Number of events 5 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.53%
1/188 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Nervous system disorders
Akathisia
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Nervous system disorders
Dizziness
|
2.7%
5/188 • Number of events 6 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.6%
3/185 • Number of events 3 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Nervous system disorders
Headache
|
1.6%
3/188 • Number of events 5 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
5.9%
11/185 • Number of events 13 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Nervous system disorders
Somnolence
|
10.6%
20/188 • Number of events 29 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.6%
3/185 • Number of events 3 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Psychiatric disorders
Anxiety
|
0.53%
1/188 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.1%
2/185 • Number of events 3 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Psychiatric disorders
Restlessness
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Renal and urinary disorders
Urinary retention
|
0.53%
1/188 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Reproductive system and breast disorders
Breast pain
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.00%
0/185 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.53%
1/188 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
1.6%
3/185 • Number of events 6 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 1 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/188 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
0.54%
1/185 • Number of events 2 • Day 2 to Day 4 after chemotherapy
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
|
Additional Information
Rudolph M. Navari, MD, PhD, FACP
Indiana University School of Medicine South Bend
Phone: 574-252-7225
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60