This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,015
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 through Day 17, inclusive
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.
Time frame: 0 to 120 hours after initiation of MEC
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.
Time frame: 0 to 24 hours after initiation of MEC
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.
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Time frame: 0 to 120 hours after initiation of MEC