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Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

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ClinicalTrials.gov Identifier: NCT01594749
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : September 25, 2015
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Chemotherapy-Induced Nausea and Vomiting (CINV)
Interventions Drug: Fosaprepitant dimeglumine
Drug: Fosaprepitant Placebo
Drug: Dexamethasone
Drug: Ondansetron
Drug: Dexamethasone Placebo
Drug: Ondansetron Placebo
Drug: Rescue Therapy
Enrollment 1015
Recruitment Details  
Pre-assignment Details A total of 14 participants did not receive any study drug: 4 in the Fosaprepitant Regimen and 10 in the Control Regimen. One participant who was randomized to the Control Regimen received the Fosaprepitant Regimen.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 507 508
Treated 503 498
Completed 485 490
Not Completed 22 18
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             2             2
Protocol Violation             2             0
Physician Decision             1             1
Non-compliance with Protocol             0             1
Lost to Follow-up             1             0
Death             9             3
Not Treated             4             10
Lost Source Documentation             1             0
Arm/Group Title Fosaprepitant Regimen Control Regimen Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 502 498 1000
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 502 participants 498 participants 1000 participants
60.0  (11.8) 59.1  (12.3) 59.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 502 participants 498 participants 1000 participants
Female
298
  59.4%
293
  58.8%
591
  59.1%
Male
204
  40.6%
205
  41.2%
409
  40.9%
1.Primary Outcome
Title Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
Hide Description A Complete Response was defined as no vomiting and no use of rescue medication.
Time Frame 25 to 120 hours after initiation of MEC
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 502 498
Measure Type: Number
Unit of Measure: Percentage of Participants
78.9 68.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant Regimen, Control Regimen
Comments Percentage difference in Fosaprepitant Regimen vs. Control Regimen
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Infusion-site Thrombophlebitis
Hide Description 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.
Time Frame Day 1 through Day 17, inclusive
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population consisted of all randomized participants who received study drug as treated.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 504 497
Measure Type: Number
Unit of Measure: Percentage of Participants
0.6 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant Regimen, Control Regimen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments P-value based on Miettinen & Nurminen method
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage vs. Control
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.2 to 1.7
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With Severe Infusion-site Reactions
Hide Description 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.
Time Frame Day 1 through Day 17, inclusive
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population consisted of all randomized participants who received study drug as treated.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 504 497
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0
4.Secondary Outcome
Title Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC
Hide Description A Complete Response was defined as no vomiting and no use of rescue medication.
Time Frame 0 to 120 hours after initiation of MEC
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 502 498
Measure Type: Number
Unit of Measure: Percentage of Participants
77.1 66.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant Regimen, Control Regimen
Comments Percentage difference in Fosaprepitant Regimen vs. Control Regimen
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value based on CMH method with stratification of gender
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC
Hide Description A Complete Response was defined as no vomiting and no use of rescue medication.
Time Frame 0 to 24 hours after initiation of MEC
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 502 498
Measure Type: Number
Unit of Measure: Percentage of Participants
93.2 91.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant Regimen, Control Regimen
Comments Percentage difference in Fosaprepitant Regimen vs. Control Regimen
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments P-value based on CMH method with stratification of gender
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC
Hide Description 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.
Time Frame 0 to 120 hours after initiation of MEC
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 502 498
Measure Type: Number
Unit of Measure: Percentage of participants
82.7 72.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant Regimen, Control Regimen
Comments Percentage difference in Fosaprepitant Regimen vs. Control Regimen
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value based on CMH method with stratification of gender
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
Adverse Event Reporting Description The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received.
 
Arm/Group Title Fosaprepitant Regimen Control Regimen
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Fosaprepitant Regimen Control Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Fosaprepitant Regimen Control Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/504 (7.74%)      35/497 (7.04%)    
Blood and lymphatic system disorders     
Abdominal lymphadenopathy  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Anaemia  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Febrile neutropenia  1  8/504 (1.59%)  8 5/497 (1.01%)  5
Leukocytosis  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Leukopenia  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Neutropenia  1  3/504 (0.60%)  3 4/497 (0.80%)  4
Cardiac disorders     
Angina pectoris  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Atrial fibrillation  1  1/504 (0.20%)  1 1/497 (0.20%)  2
Cardiac arrest  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Cardiac disorder  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Supraventricular tachycardia  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Colitis  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Constipation  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Diarrhoea  1  1/504 (0.20%)  1 1/497 (0.20%)  1
Gastrointestinal disorder  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Gastrooesophageal reflux disease  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Nausea  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Neutropenic colitis  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Pancreatitis  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Vomiting  1  1/504 (0.20%)  1 1/497 (0.20%)  1
General disorders     
Asthenia  1  1/504 (0.20%)  1 2/497 (0.40%)  2
Death  1  2/504 (0.40%)  2 0/497 (0.00%)  0
Disease progression  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Fatigue  1  1/504 (0.20%)  1 1/497 (0.20%)  1
Pyrexia  1  2/504 (0.40%)  2 1/497 (0.20%)  1
Hepatobiliary disorders     
Hepatorenal failure  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Hypersensitivity  1  1/504 (0.20%)  1 1/497 (0.20%)  1
Infections and infestations     
Diverticulitis  1  0/504 (0.00%)  0 2/497 (0.40%)  2
Influenza  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Lower respiratory tract infection  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Oral candidiasis  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Pneumonia  1  1/504 (0.20%)  1 3/497 (0.60%)  3
Respiratory tract infection  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Sepsis  1  2/504 (0.40%)  2 0/497 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Toxicity to various agents  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Investigations     
Blood glucose increased  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Haemoglobin decreased  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Dehydration  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/504 (0.20%)  1 2/497 (0.40%)  2
Myalgia  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Metastases to bone  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Non-small cell lung cancer  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Epilepsy  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Syncope  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Transient ischaemic attack  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Psychiatric disorders     
Mental status changes  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  1/504 (0.20%)  1 1/497 (0.20%)  1
Pleural effusion  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Pneumothorax  1  0/504 (0.00%)  0 1/497 (0.20%)  1
Pulmonary embolism  1  2/504 (0.40%)  2 0/497 (0.00%)  0
Vascular disorders     
Thrombosis  1  1/504 (0.20%)  1 0/497 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fosaprepitant Regimen Control Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   190/504 (37.70%)      193/497 (38.83%)    
Blood and lymphatic system disorders     
Neutropenia  1  38/504 (7.54%)  38 33/497 (6.64%)  33
Gastrointestinal disorders     
Constipation  1  47/504 (9.33%)  48 51/497 (10.26%)  53
Diarrhoea  1  63/504 (12.50%)  66 55/497 (11.07%)  57
General disorders     
Fatigue  1  75/504 (14.88%)  78 64/497 (12.88%)  64
Metabolism and nutrition disorders     
Decreased appetite  1  26/504 (5.16%)  27 32/497 (6.44%)  32
Nervous system disorders     
Headache  1  30/504 (5.95%)  32 35/497 (7.04%)  37
Skin and subcutaneous tissue disorders     
Alopecia  1  11/504 (2.18%)  11 26/497 (5.23%)  26
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01594749    
Other Study ID Numbers: 0517-031
First Submitted: April 24, 2012
First Posted: May 9, 2012
Results First Submitted: August 26, 2015
Results First Posted: September 25, 2015
Last Update Posted: September 4, 2018