Olanzapine for the Prevention of Chemotherapy Induced Nau... | NCT04503668

ID	Type	Description	Link
HUM00175458	Other Identifier	University of Michigan

Label	Type	Description	Intervention Names
Nk1-RA	Active Comparator	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.	Drug: Ondansetron Drug: Dexamethasone Drug: Neurokinin-1 Receptor Antagonist (NK1-RA) Drug: Compazine
Olanzapine	Experimental	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.	Drug: Ondansetron Drug: Dexamethasone Drug: Olanzapine Drug: Compazine

Name	Type	Description	Arm Group Labels	Other Names
Ondansetron	Drug	8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy	Nk1-RA Olanzapine

Measure	Description	Time Frame
Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)	Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.	120 hours post initiating chemotherapy during cycle 1

Measure	Description	Time Frame
Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)	Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.	24 hours post initiating chemotherapy during cycle 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of gynecologic malignancy
No chemotherapy in the last 12 months
Scheduled to receive Carboplatin (AUC>=4) and Paclitaxel every three weeks
ECOG performance status 0 or 1
English speaking
Willing and able to provide informed consent
Laboratory values within protocol-defined parameters
No vomiting in the 24 hours prior to initiating chemotherapy
If childbearing potential exists, negative pregnancy test within 7 days prior to registration

Exclusion Criteria:

Significant cognitive compromise
History of CNS disease (e.g. brain metastases, seizure disorder, dementia)
Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)
Concurrent radiotherapy treatment
Known hypersensitivity to olanzapine
Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months
History of diabetes mellitus on medication (insulin or oral glycemic agent)
Alcohol abuse / chronic alcoholism
History of closed angle glaucoma
Current enrollment in other clinical trials

Name	Affiliation	Role
Aimee Rolston	University of Michigan Rogel Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Rogel Cancer Center		Ann Arbor	Michigan	48109	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 4, 2020

Arm/Group Information

ID	Title	Description
BG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
BG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00027 BG00124 BG00251

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Posted

Count of Participants

Participants

120 hours post initiating chemotherapy during cycle 1

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units	Counts
Participants	OG00027 OG00124

Title

Denominators

Categories

Title	Measurements
	OG00011 OG00114

Secondary

Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Posted

Count of Participants

Participants

24 hours post initiating chemotherapy during cycle 1

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units

Secondary

Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Posted

Count of Participants

Participants

24-120 hours post initiating chemotherapy during cycle 1

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units

Secondary

Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)

Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).

Posted

Count of Participants

Participants

24 hours post initiating chemotherapy during cycle 1

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units	Counts

Secondary

Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)

Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).

Posted

Count of Participants

Participants

120 hours post initiating chemotherapy during cycle 1

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units	Counts

Secondary

Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)

Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).

Posted

Count of Participants

Participants

120 hours post initiating chemotherapy during cycle 1

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units	Counts

Secondary

Mean Somnolence Score

Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).

Posted

Mean

95% Confidence Interval

score on a scale

assessed daily, and reported at day 6 post final study treatment

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Units	Counts

Secondary

Mean Increased-appetite Score

Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).

Posted

Mean

95% Confidence Interval

score on a scale

assessed daily, and reported at day 6 post final study treatment

ID	Title	Description
OG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
OG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nk1-RA	Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	4	27	3	27	24	27
EG001	Olanzapine	Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	6	24	5	24	23	24

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected24 at risk
anemia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected24 at risk
syncope	Nervous system disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected24 at risk
fall	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected24 at risk
dizziness	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected24 at risk
hyponatremia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected24 at risk
creatinine increased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected24 at risk
vomiting	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0012 events2 affected24 at risk
nausea	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected24 at risk
dysphagia	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected24 at risk
dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected24 at risk
debulking surgery	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected24 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0012 events2 affected24 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0009 events8 affected27 at risk EG00110 events8 affected24 at risk
abdominal cramping	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected24 at risk
abdominal distention	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0011 events1 affected24 at risk
alanine aminotransferase increased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0011 events1 affected24 at risk
alkaline phosphatase increased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0005 events5 affected27 at risk EG0013 events2 affected24 at risk
alopecia	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0007 events6 affected27 at risk EG0012 events2 affected24 at risk
anemia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG00018 events10 affected27 at risk EG0018 events6 affected24 at risk
anorexia	Psychiatric disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0013 events3 affected24 at risk
arthralgia	Musculoskeletal and connective tissue disorders	CTCAE version 5.0	Non-systematic Assessment	EG0005 events4 affected27 at risk EG00110 events6 affected24 at risk
aspartate aminotransferase increased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0013 events3 affected24 at risk
back pain	Musculoskeletal and connective tissue disorders	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0013 events3 affected24 at risk
bloating	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0011 events1 affected24 at risk
cognitive disturbance	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected24 at risk
constipation	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0007 events7 affected27 at risk EG00114 events10 affected24 at risk
creatinine increased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0013 events2 affected24 at risk
diarrhea	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0005 events3 affected27 at risk EG00110 events9 affected24 at risk
dizziness	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0006 events5 affected27 at risk EG0010 events0 affected24 at risk
dry mouth	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected24 at risk
dyspepsia	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0012 events2 affected24 at risk
dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0003 events3 affected27 at risk EG0012 events1 affected24 at risk
edema limbs	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0012 events2 affected24 at risk
facial flushing	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0012 events2 affected24 at risk
Fatigue	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG00027 events19 affected27 at risk EG00112 events11 affected24 at risk
headache	General disorders	CTCAE version 5.0	Non-systematic Assessment	EG0006 events4 affected27 at risk EG0014 events4 affected24 at risk
hypoalbuminemia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected24 at risk
hypocalcemia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0014 events2 affected24 at risk
hypokalemia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0003 events3 affected27 at risk EG0012 events2 affected24 at risk
hypomagnesemia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected24 at risk
hyponatremia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0003 events3 affected27 at risk EG0014 events4 affected24 at risk
Insomnia	Psychiatric disorders	CTCAE version 5.0	Non-systematic Assessment	EG0004 events4 affected27 at risk EG0013 events2 affected24 at risk
lymphocyte count decreased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0008 events6 affected27 at risk EG0013 events2 affected24 at risk
myalgia	Musculoskeletal and connective tissue disorders	CTCAE version 5.0	Non-systematic Assessment	EG0003 events2 affected27 at risk EG0018 events6 affected24 at risk
nausea	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG00019 events12 affected27 at risk EG00120 events15 affected24 at risk
neuropathy	Nervous system disorders	CTCAE version 5.0	Non-systematic Assessment	EG0005 events4 affected27 at risk EG0015 events5 affected24 at risk
neutropenia	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0000 events0 affected27 at risk EG0012 events2 affected24 at risk
peripheral sensory neuropathy	Nervous system disorders	CTCAE version 5.0	Non-systematic Assessment	EG0001 events1 affected27 at risk EG0016 events5 affected24 at risk
platelet count decreased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0007 events5 affected27 at risk EG0014 events2 affected24 at risk
presyncope	Cardiac disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected24 at risk
rash	Skin and subcutaneous tissue disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events2 affected27 at risk EG0012 events2 affected24 at risk
vomiting	Gastrointestinal disorders	CTCAE version 5.0	Non-systematic Assessment	EG0002 events1 affected27 at risk EG0019 events6 affected24 at risk
white blood cell decreased	Investigations	CTCAE version 5.0	Non-systematic Assessment	EG0003 events2 affected27 at risk EG0011 events1 affected24 at risk

ID	Term
D017294	Ondansetron
D003907	Dexamethasone
D064729	Neurokinin-1 Receptor Antagonists
C579707	fosaprepitant
D000077152	Olanzapine
D011346	Prochlorperazine

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D002227	Carbazoles
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006575	Heterocyclic Compounds, 3-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D045505	Physiological Effects of Drugs
D001569	Benzodiazepines
D001552	Benzazepines
D010640	Phenothiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals