Antiemetic Therapy With or Without Olanzapine in Preventi... | NCT02116530

NCT02116530

ID	Type	Description	Link
NCI-2014-00446	Other Identifier	NCI Clinical Trial Reporting Program
U10CA031946	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olanzapine + Chemotherapy + Antiemetic treatment	Experimental	Patients will 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)	Drug: Olanzapine Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Placebo + Chemotherapy + Antiemetic treatment	Active Comparator	Patients will 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	Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin) Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant) Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine	Drug	oral	Olanzapine + Chemotherapy + Antiemetic treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Module

Name	Affiliation	Role
Rudolph M. Navari, MD, PhD, FACP	Indiana University School of Medicine South Bend	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Anchorage Associates in Radiation Medicine		Anchorage	Alaska	98508	United States
Anchorage Radiation Therapy Center

PubMed Identifier	Type	Citation	Retractions
27410922	Derived	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.

Label	URL
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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)
BG001	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00058(29 to 86) BG00156(28 to 89) BG00257(28 to 89)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000139 BG001136 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0011 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000192 BG001188 BG002

5-hydroxytryptamine type 3 receptor antagonist

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Palonosetron	BG000145 BG001143 BG002

Chemotherapy regimen

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Cisplatin-containing regimen	BG00071 BG00165 BG002

Primary site of disease

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Breast	BG000120 BG001122 BG002

Eastern Cooperative Oncology Group (ECOG) Performance Status

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0=Asymptomatic and fully active	BG000149 BG001144 BG002

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

Proportion of Patients With no Nausea

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.

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

Posted

Number

percentage of participants

0 to 120 hours after chemotherapy

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000183 OG001181

Title

Denominators

Categories

0-24 hours after chemotherapy

- ParticipantsOG000183
- ParticipantsOG001181

Title	Measurements
	OG00073.8

Secondary

Median Nausea Scores

Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).

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.

Posted

Median

Full Range

units on a scale

Baseline and Day 2 to Day 6 after chemotherapy

ID	Title	Description
OG000	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)
OG001	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

Secondary

Proportion of Patients With Complete Response

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.

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.

Posted

Number

percentage of participants

0 to 120 hours after chemotherapy

ID	Title	Description
OG000	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)
OG001	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

Secondary

Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire

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).

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.

Posted

Mean

Standard Deviation

units on a scale

Baseline and day 2 to 6 days after chemotherapy

ID	Title	Description
OG000	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)
OG001	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

Secondary

Frequency of Rescue Medication

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.

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.

Posted

Count of Participants

Participants

Day 2 to Day 6 after chemotherapy

ID	Title	Description
OG000	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)
OG001	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

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	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)			3	188	44	188
EG001	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			0	185	36	185

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0013 events1 affected185 at risk
Blurred vision	Eye disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0011 events1 affected185 at risk
Dry eye	Eye disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Abdominal pain	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0002 events1 affected188 at risk EG0011 events1 affected185 at risk
Bloating	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0012 events2 affected185 at risk
Constipation	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0005 events4 affected188 at risk EG0012 events2 affected185 at risk
Diarrhea	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0013 events2 affected185 at risk
Dry mouth	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0004 events3 affected188 at risk EG0012 events1 affected185 at risk
Dyspepsia	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0018 events6 affected185 at risk
Flatulence	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0003 events2 affected188 at risk EG0010 events0 affected185 at risk
Gastrointestinal disorders - Other, specify	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0004 events2 affected188 at risk EG0011 events1 affected185 at risk
Nausea	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0008 events5 affected188 at risk EG00117 events9 affected185 at risk
Stomach pain	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Vomiting	Gastrointestinal disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0014 events2 affected185 at risk
Edema limbs	General disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Fatigue	General disorders	CTCAEV4.0	Systematic Assessment	EG00013 events11 affected188 at risk EG00112 events9 affected185 at risk
General disorders and administration site conditions - Other, specify	General disorders	CTCAEV4.0	Systematic Assessment	EG0002 events1 affected188 at risk EG0011 events1 affected185 at risk
Platelet count decreased	Investigations	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
White blood cell decreased	Investigations	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Anorexia	Metabolism and nutrition disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0015 events4 affected185 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAEV4.0	Systematic Assessment	EG0002 events1 affected188 at risk EG0011 events1 affected185 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Akathisia	Nervous system disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Dizziness	Nervous system disorders	CTCAEV4.0	Systematic Assessment	EG0006 events5 affected188 at risk EG0013 events3 affected185 at risk
Dysgeusia	Nervous system disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events1 affected185 at risk
Headache	Nervous system disorders	CTCAEV4.0	Systematic Assessment	EG0005 events3 affected188 at risk EG00113 events11 affected185 at risk
Somnolence	Nervous system disorders	CTCAEV4.0	Systematic Assessment	EG00029 events20 affected188 at risk EG0013 events3 affected185 at risk
Anxiety	Psychiatric disorders	CTCAEV4.0	Systematic Assessment	EG0002 events1 affected188 at risk EG0010 events0 affected185 at risk
Insomnia	Psychiatric disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0013 events2 affected185 at risk
Restlessness	Psychiatric disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Renal calculi	Renal and urinary disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Renal colic	Renal and urinary disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Urinary incontinence	Renal and urinary disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Urinary retention	Renal and urinary disorders	CTCAEV4.0	Systematic Assessment	EG0002 events1 affected188 at risk EG0010 events0 affected185 at risk
Breast pain	Reproductive system and breast disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0016 events3 affected185 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Urticaria	Skin and subcutaneous tissue disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0011 events1 affected185 at risk
Hypertension	Vascular disorders	CTCAEV4.0	Systematic Assessment	EG0000 events0 affected188 at risk EG0012 events1 affected185 at risk

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D013812	Therapeutics
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D002227	Carbazoles
D007211	Indoles
D006575	Heterocyclic Compounds, 3-Ring
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D007191	Indazoles
D011720	Pyrazoles
D019086	Bridged Bicyclo Compounds, Heterocyclic
D006572	Heterocyclic Compounds, Bridged-Ring
D011812	Quinuclidines
D007546	Isoquinolines
D009025	Morpholines
D010078	Oxazines

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077152	Olanzapine
D004358	Drug Therapy
D002945	Cisplatin
D003520	Cyclophosphamide
D004317	Doxorubicin
D017294	Ondansetron
D017829	Granisetron
D000077924	Palonosetron
D000077608	Aprepitant

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutrophil count decreased	Investigations	CTCAEV4.0	Systematic Assessment	EG0002 events2 affected188 at risk EG0010 events0 affected185 at risk
White blood cell decreased	Investigations	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk
Thromboembolic event	Vascular disorders	CTCAEV4.0	Systematic Assessment	EG0001 events1 affected188 at risk EG0010 events0 affected185 at risk