Trial Outcomes & Findings for Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031) (NCT NCT01594749)
NCT ID: NCT01594749
Last Updated: 2018-09-04
Results Overview
A Complete Response was defined as no vomiting and no use of rescue medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1015 participants
Primary outcome timeframe
25 to 120 hours after initiation of MEC
Results posted on
2018-09-04
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
507
|
508
|
|
Overall Study
Treated
|
503
|
498
|
|
Overall Study
COMPLETED
|
485
|
490
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Non-compliance with Protocol
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
9
|
3
|
|
Overall Study
Not Treated
|
4
|
10
|
|
Overall Study
Lost Source Documentation
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)
Baseline characteristics by cohort
| Measure |
Fosaprepitant Regimen
n=502 Participants
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.
|
Control Regimen
n=498 Participants
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
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
59.6 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
591 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 25 to 120 hours after initiation of MECPopulation: 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.
A Complete Response was defined as no vomiting and no use of rescue medication.
Outcome measures
| Measure |
Fosaprepitant Regimen
n=502 Participants
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.
|
Control Regimen
n=498 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
|
78.9 Percentage of Participants
|
68.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 17, inclusivePopulation: The Safety population consisted of all randomized participants who received study drug as treated.
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.
Outcome measures
| Measure |
Fosaprepitant Regimen
n=504 Participants
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.
|
Control Regimen
n=497 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Infusion-site Thrombophlebitis
|
0.6 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 17, inclusivePopulation: The Safety population consisted of all randomized participants who received study drug as treated.
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.
Outcome measures
| Measure |
Fosaprepitant Regimen
n=504 Participants
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.
|
Control Regimen
n=497 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Severe Infusion-site Reactions
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 0 to 120 hours after initiation of MECPopulation: 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.
A Complete Response was defined as no vomiting and no use of rescue medication.
Outcome measures
| Measure |
Fosaprepitant Regimen
n=502 Participants
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.
|
Control Regimen
n=498 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC
|
77.1 Percentage of Participants
|
66.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 0 to 24 hours after initiation of MECPopulation: 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.
A Complete Response was defined as no vomiting and no use of rescue medication.
Outcome measures
| Measure |
Fosaprepitant Regimen
n=502 Participants
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.
|
Control Regimen
n=498 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC
|
93.2 Percentage of Participants
|
91.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 0 to 120 hours after initiation of MECPopulation: 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.
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.
Outcome measures
| Measure |
Fosaprepitant Regimen
n=502 Participants
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.
|
Control Regimen
n=498 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC
|
82.7 Percentage of participants
|
72.9 Percentage of participants
|
Adverse Events
Fosaprepitant Regimen
Serious events: 39 serious events
Other events: 190 other events
Deaths: 0 deaths
Control Regimen
Serious events: 35 serious events
Other events: 193 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fosaprepitant Regimen
n=504 participants at risk
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.
|
Control Regimen
n=497 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
8/504 • Number of events 8 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
1.0%
5/497 • Number of events 5 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.60%
3/504 • Number of events 3 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.80%
4/497 • Number of events 4 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Colitis
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
General disorders
Asthenia
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.40%
2/497 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
General disorders
Death
|
0.40%
2/504 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
General disorders
Disease progression
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
General disorders
Fatigue
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
General disorders
Pyrexia
|
0.40%
2/504 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Immune system disorders
Drug hypersensitivity
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Immune system disorders
Hypersensitivity
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.40%
2/497 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Oral candidiasis
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Pneumonia
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.60%
3/497 • Number of events 3 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Infections and infestations
Sepsis
|
0.40%
2/504 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Investigations
Blood glucose increased
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.40%
2/497 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Nervous system disorders
Epilepsy
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Nervous system disorders
Syncope
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Psychiatric disorders
Mental status changes
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/504 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.20%
1/497 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
2/504 • Number of events 2 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Vascular disorders
Thrombosis
|
0.20%
1/504 • Number of events 1 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
0.00%
0/497 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
Other adverse events
| Measure |
Fosaprepitant Regimen
n=504 participants at risk
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.
|
Control Regimen
n=497 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.5%
38/504 • Number of events 38 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
6.6%
33/497 • Number of events 33 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Constipation
|
9.3%
47/504 • Number of events 48 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
10.3%
51/497 • Number of events 53 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
63/504 • Number of events 66 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
11.1%
55/497 • Number of events 57 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
General disorders
Fatigue
|
14.9%
75/504 • Number of events 78 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
12.9%
64/497 • Number of events 64 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
26/504 • Number of events 27 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
6.4%
32/497 • Number of events 32 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Nervous system disorders
Headache
|
6.0%
30/504 • Number of events 32 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
7.0%
35/497 • Number of events 37 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
11/504 • Number of events 11 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
5.2%
26/497 • Number of events 26 • Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug)
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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER