Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

• ClinicalTrials.gov Identifier: NCT02116530
• Recruitment Status: Completed
• First Posted: April 17, 2014
• Results First Posted: April 10, 2017
• Last Update Posted: May 7, 2020
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Conditions: Hematopoietic/Lymphoid Cancer; Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: Olanzapine; Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin); Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant); Other: Placebo
• Enrollment: 401

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Olanzapine	Placebo
Arm/Group Description	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)	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
Period Title: Overall Study
Started	192	188
Completed	183	184
Not Completed	9	4
Reason Not Completed
Withdrawal by Subject	1	2
Adverse Event	4	0
Physician Decision	1	0
Lost to Follow-up	1	0
Other Medical Problems	2	2

Baseline Characteristics

Arm/Group Title		Olanzapine	Placebo	Total
Arm/Group Description		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)	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 of all reporting groups
Overall Number of Baseline Participants		192	188	380
Baseline Analysis Population Description		All participants who started the treatment.
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	192 participants	188 participants	380 participants
		58; (29 to 86)	56; (28 to 89)	57; (28 to 89)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	188 participants	380 participants
	Female	139 72.4%	136 72.3%	275 72.4%
	Male	53 27.6%	52 27.7%	105 27.6%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	188 participants	380 participants
	American Indian or Alaska Native	3 1.6%	1 0.5%	4 1.1%
	Asian	5 2.6%	4 2.1%	9 2.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	9 4.7%	9 4.8%	18 4.7%
	White	172 89.6%	171 91.0%	343 90.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 1.6%	3 1.6%	6 1.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	192 participants	188 participants	380 participants
		192	188	380
5-hydroxytryptamine type 3 receptor antagonist; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	188 participants	380 participants
	Palonosetron	145 75.5%	143 76.1%	288 75.8%
	Ondansetron	46 24.0%	44 23.4%	90 23.7%
	Granisetron	1 0.5%	1 0.5%	2 0.5%
Chemotherapy regimen; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	188 participants	380 participants
	Cisplatin-containing regimen	71 37.0%	65 34.6%	136 35.8%
	Anthracyline and cyclophosphamide	121 63.0%	123 65.4%	244 64.2%
Primary site of disease; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	188 participants	380 participants
	Breast	120 62.5%	122 64.9%	242 63.7%
	Lung	27 14.1%	22 11.7%	49 12.9%
	Other	45 23.4%	44 23.4%	89 23.4%
Eastern Cooperative Oncology Group (ECOG) Performance Status; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	192 participants	188 participants	380 participants
	0=Asymptomatic and fully active	149	144	293
	1=Symptomatic and fully ambulatory	40	41	81
	2=Symptomatic, <50% in bed during the day	2	3	5
	Not assessed	1	0	1

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With no Nausea
Description	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.
Time Frame	0 to 120 hours after chemotherapy

Outcome Measure Data

Analysis Population Description

All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.

Arm/Group Title		Olanzapine	Placebo
Arm/Group Description:		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)	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 Number of Participants Analyzed		183	181
Measure Type: Number; Unit of Measure: percentage of participants
0-24 hours after chemotherapy	Number Analyzed	183 participants	181 participants
		73.8	45.3
25-120 hours after chemotherapy	Number Analyzed	177 participants	177 participants
		42.4	25.4
0-120 hours after chemotherapy	Number Analyzed	177 participants	178 participants
		37.3	21.9

2. Secondary Outcome

Title	Median Nausea Scores
Description	Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Time Frame	Baseline and Day 2 to Day 6 after chemotherapy

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Olanzapine	Placebo
Arm/Group Description:		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)	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 Number of Participants Analyzed		190	188
Median (Full Range); Unit of Measure: units on a scale
Baseline	Number Analyzed	190 participants	188 participants
		0; (0 to 7)	0; (0 to 9)
Day 2	Number Analyzed	183 participants	181 participants
		0; (0 to 10)	1; (0 to 10)
Day 3	Number Analyzed	182 participants	180 participants
		0; (0 to 9)	1; (0 to 10)
Day 4	Number Analyzed	179 participants	179 participants
		0; (0 to 8)	1; (0 to 9)
Day 5	Number Analyzed	179 participants	174 participants
		0; (0 to 10)	1; (0 to 10)
Day 6	Number Analyzed	176 participants	174 participants
		0; (0 to 9)	1; (0 to 10)

3. Secondary Outcome

Title	Proportion of Patients With Complete Response
Description	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.
Time Frame	0 to 120 hours after chemotherapy

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Olanzapine	Placebo
Arm/Group Description:		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)	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 Number of Participants Analyzed		182	181
Measure Type: Number; Unit of Measure: percentage of participants
0-24 hours after chemotherapy	Number Analyzed	182 participants	181 participants
		85.7	64.6
25-120 hours after chemotherapy	Number Analyzed	163 participants	168 participants
		66.9	52.4
0-120 hours after chemotherapy	Number Analyzed	162 participants	170 participants
		63.6	40.6

4. Secondary Outcome

Title	Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Description	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).
Time Frame	Baseline and day 2 to 6 days after chemotherapy

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Olanzapine	Placebo
Arm/Group Description:		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)	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 Number of Participants Analyzed		190	188
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline Undesired Sedation	Number Analyzed	190 participants	188 participants
		0.4 (1.2)	0.5 (1.5)
Day 2 Undesired Sedation	Number Analyzed	181 participants	181 participants
		2.3 (3.2)	1.2 (2.2)
Day 3 Undesired Sedation	Number Analyzed	182 participants	180 participants
		1.6 (2.5)	1.4 (2.3)
Day 4 Undesired Sedation	Number Analyzed	179 participants	179 participants
		1.5 (2.3)	1.4 (2.3)
Day 5 Undesired Sedation	Number Analyzed	179 participants	173 participants
		1.2 (2.1)	1.2 (2.1)
Day 6 Undesired Sedation	Number Analyzed	175 participants	174 participants
		0.9 (1.8)	1.3 (2.2)
Baseline Appetite Increase	Number Analyzed	190 participants	187 participants
		0.6 (1.7)	0.3 (0.9)
Day 2 Appetite Increase	Number Analyzed	183 participants	181 participants
		0.7 (1.6)	0.5 (1.5)
Day 3 Appetite Increase	Number Analyzed	182 participants	180 participants
		0.7 (1.5)	0.6 (1.7)
Day 4 Appetite Increase	Number Analyzed	179 participants	179 participants
		1.0 (1.8)	0.7 (1.7)
Day 5 Appetite Increase	Number Analyzed	179 participants	174 participants
		1.0 (1.8)	0.7 (1.7)
Day 6 Appetite Increase	Number Analyzed	176 participants	174 participants
		1.1 (2.0)	0.7 (1.7)

5. Secondary Outcome

Title	Frequency of Rescue Medication
Description	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.
Time Frame	Day 2 to Day 6 after chemotherapy

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Olanzapine	Placebo
Arm/Group Description:		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)	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 Number of Participants Analyzed		182	181
Measure Type: Count of Participants; Unit of Measure: Participants
Day 2	Number Analyzed	182 participants	181 participants
	None	156 85.7%	117 64.6%
	Once	21 11.5%	35 19.3%
	Twice	3 1.6%	19 10.5%
	More than twice	2 1.1%	10 5.5%
Day 3	Number Analyzed	180 participants	178 participants
	None	158 87.8%	124 69.7%
	Once	11 6.1%	24 13.5%
	Twice	7 3.9%	20 11.2%
	More than twice	4 2.2%	10 5.6%
Day 4	Number Analyzed	170 participants	176 participants
	None	141 82.9%	124 70.5%
	Once	16 9.4%	24 13.6%
	Twice	10 5.9%	17 9.7%
	More than twice	3 1.8%	11 6.3%
Day 5	Number Analyzed	173 participants	171 participants
	None	145 83.8%	131 76.6%
	Once	19 11.0%	23 13.5%
	Twice	5 2.9%	7 4.1%
	More than twice	4 2.3%	10 5.8%
Day 6	Number Analyzed	171 participants	171 participants
	None	143 83.6%	130 76.0%
	Once	12 7.0%	16 9.4%
	Twice	12 7.0%	11 6.4%
	More than twice	4 2.3%	14 8.2%

Adverse Events

Time Frame	Day 2 to Day 4 after chemotherapy
Adverse Event Reporting Description	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.
Arm/Group Title	Olanzapine		Placebo
Arm/Group Description	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)		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
All-Cause Mortality
	Olanzapine		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Olanzapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/188 (1.60%)		0/185 (0.00%)
Investigations
Neutrophil count decreased † 1	2/188 (1.06%)	2	0/185 (0.00%)	0
White blood cell decreased † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Vascular disorders
Thromboembolic event † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAEV4.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Olanzapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/188 (23.40%)		36/185 (19.46%)
Cardiac disorders
Palpitations † 1	0/188 (0.00%)	0	1/185 (0.54%)	3
Eye disorders
Blurred vision † 1	1/188 (0.53%)	1	1/185 (0.54%)	1
Dry eye † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Gastrointestinal disorders
Abdominal pain † 1	1/188 (0.53%)	2	1/185 (0.54%)	1
Bloating † 1	1/188 (0.53%)	1	2/185 (1.08%)	2
Constipation † 1	4/188 (2.13%)	5	2/185 (1.08%)	2
Diarrhea † 1	0/188 (0.00%)	0	2/185 (1.08%)	3
Dry mouth † 1	3/188 (1.60%)	4	1/185 (0.54%)	2
Dyspepsia † 1	0/188 (0.00%)	0	6/185 (3.24%)	8
Flatulence † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Gastroesophageal reflux disease † 1	2/188 (1.06%)	3	0/185 (0.00%)	0
Gastrointestinal disorders - Other, specify † 1	2/188 (1.06%)	4	1/185 (0.54%)	1
Nausea † 1	5/188 (2.66%)	8	9/185 (4.86%)	17
Stomach pain † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Vomiting † 1	1/188 (0.53%)	1	2/185 (1.08%)	4
General disorders
Edema limbs † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Fatigue † 1	11/188 (5.85%)	13	9/185 (4.86%)	12
General disorders and administration site conditions - Other, specify † 1	1/188 (0.53%)	2	1/185 (0.54%)	1
Investigations
Platelet count decreased † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
White blood cell decreased † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Metabolism and nutrition disorders
Anorexia † 1	0/188 (0.00%)	0	4/185 (2.16%)	5
Hyperglycemia † 1	1/188 (0.53%)	2	1/185 (0.54%)	1
Musculoskeletal and connective tissue disorders
Myalgia † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Nervous system disorders
Akathisia † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Dizziness † 1	5/188 (2.66%)	6	3/185 (1.62%)	3
Dysgeusia † 1	0/188 (0.00%)	0	1/185 (0.54%)	2
Headache † 1	3/188 (1.60%)	5	11/185 (5.95%)	13
Somnolence † 1	20/188 (10.64%)	29	3/185 (1.62%)	3
Psychiatric disorders
Anxiety † 1	1/188 (0.53%)	2	0/185 (0.00%)	0
Insomnia † 1	0/188 (0.00%)	0	2/185 (1.08%)	3
Restlessness † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Renal and urinary disorders
Renal calculi † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Renal colic † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Urinary incontinence † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Urinary retention † 1	1/188 (0.53%)	2	0/185 (0.00%)	0
Reproductive system and breast disorders
Breast pain † 1	1/188 (0.53%)	1	0/185 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Hiccups † 1	1/188 (0.53%)	1	3/185 (1.62%)	6
Sore throat † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Skin and subcutaneous tissue disorders
Urticaria † 1	0/188 (0.00%)	0	1/185 (0.54%)	1
Vascular disorders
Hypertension † 1	0/188 (0.00%)	0	1/185 (0.54%)	2
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, CTCAEV4.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Rudolph M. Navari, MD, PhD, FACP
• Organization: Indiana University School of Medicine South Bend
• Phone: 574-252-7225
• EMail: rmnavari@gmail.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT02116530
• Other Study ID Numbers: A221301; NCI-2014-00446 ( Other Identifier: NCI Clinical Trial Reporting Program ); U10CA031946 ( U.S. NIH Grant/Contract )
• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Results First Submitted: December 7, 2016
• Results First Posted: April 10, 2017
• Last Update Posted: May 7, 2020