Efficacy and Safety of Fosaprepitant Dimeglumine in Preve... | NCT01594749

NCT01594749

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fosaprepitant Regimen	Experimental	On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.	Drug: Fosaprepitant dimeglumine Drug: Dexamethasone Drug: Ondansetron Drug: Dexamethasone Placebo Drug: Ondansetron Placebo Drug: Rescue Therapy
Control Regimen	Active Comparator	On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.	Drug: Fosaprepitant Placebo Drug: Dexamethasone Drug: Ondansetron

Name	Type	Description	Arm Group Labels	Other Names
Fosaprepitant dimeglumine	Drug		Fosaprepitant Regimen	EMEND for Injection MK-0517

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)	A Complete Response was defined as no vomiting and no use of rescue medication.	25 to 120 hours after initiation of MEC
Percentage of Participants With Infusion-site Thrombophlebitis	The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.	Day 1 through Day 17, inclusive
Percentage of Participants With Severe Infusion-site Reactions	The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.	Day 1 through Day 17, inclusive

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC	A Complete Response was defined as no vomiting and no use of rescue medication.	0 to 120 hours after initiation of MEC
Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26449391	Result	Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8.
32988373

ID	Type	URL	Comment
	CSR Synopsis	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Drug: Rescue Therapy

The Baseline analysis population is consistent with the Intent-to-Treat (ITT) population, i.e., all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. Note: One participant with missing source documentation in the Fosaprepitant Regimen was excluded from the ITT population.

Arm/Group Information

ID	Title	Description
BG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
BG001	Control Regimen	On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000502 BG001498 BG0021000

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00078.9 OG00168.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Percentage difference in Fosaprepitant Regimen vs. Control Regimen	Cochran-Mantel-Haenszel		<0.001	P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender													Superiority or Other

Primary

Percentage of Participants With Infusion-site Thrombophlebitis

The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.

The Safety population consisted of all randomized participants who received study drug as treated.

Posted

Number

Percentage of Participants

Day 1 through Day 17, inclusive

ID	Title	Description
OG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
OG001	Control Regimen

Primary

Percentage of Participants With Severe Infusion-site Reactions

The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.

The Safety population consisted of all randomized participants who received study drug as treated.

Posted

Number

Percentage of Participants

Day 1 through Day 17, inclusive

ID	Title	Description
OG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
OG001	Control Regimen	On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

Secondary

Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC

A Complete Response was defined as no vomiting and no use of rescue medication.

Posted

Number

Percentage of Participants

0 to 120 hours after initiation of MEC

ID	Title	Description
OG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
OG001	Control Regimen

Secondary

Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC

A Complete Response was defined as no vomiting and no use of rescue medication.

Posted

Number

Percentage of Participants

0 to 24 hours after initiation of MEC

ID	Title	Description
OG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
OG001	Control Regimen

Secondary

Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC

No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.

Posted

Number

Percentage of participants

0 to 120 hours after initiation of MEC

ID	Title	Description
OG000	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

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	Fosaprepitant Regimen	On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.			39	504	190	504
EG001	Control Regimen	On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.			35	497	193	497

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0008 events8 affected504 at risk EG0015 events5 affected497 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected504 at risk EG0014 events4 affected497 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0012 events1 affected497 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Cardiac disorder	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0011 events1 affected497 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0011 events1 affected497 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0012 events2 affected497 at risk
Death	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected504 at risk EG0010 events0 affected497 at risk
Disease progression	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0011 events1 affected497 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected504 at risk EG0011 events1 affected497 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Hypersensitivity	Immune system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0011 events1 affected497 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0012 events2 affected497 at risk
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Oral candidiasis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0013 events3 affected497 at risk
Respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected504 at risk EG0010 events0 affected497 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Blood glucose increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Haemoglobin decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0012 events2 affected497 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Cerebral infarction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Epilepsy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Mental status changes	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0011 events1 affected497 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected504 at risk EG0011 events1 affected497 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected504 at risk EG0010 events0 affected497 at risk
Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected504 at risk EG0010 events0 affected497 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00038 events38 affected504 at risk EG00133 events33 affected497 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00048 events47 affected504 at risk EG00153 events51 affected497 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00066 events63 affected504 at risk EG00157 events55 affected497 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG00078 events75 affected504 at risk EG00164 events64 affected497 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG00027 events26 affected504 at risk EG00132 events32 affected497 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00032 events30 affected504 at risk EG00137 events35 affected497 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00011 events11 affected504 at risk EG00126 events26 affected497 at risk

ID	Term
D014839	Vomiting

ID	Term
C579707	fosaprepitant
D000077608	Aprepitant
D003907	Dexamethasone
D002123	Calcium Dobesilate
D017294	Ondansetron

Ancestor Terms

ID	Term
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D007093	Imidazoles
D001393	Azoles
D002227	Carbazoles
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006575	Heterocyclic Compounds, 3-Ring

On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms