Trial · NCT01636947
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)
NCT01636947, Phase 4, Completed, Merck Sharp & Dohme LLC; results first posted 2015-07-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC). Trials, record NCT01636947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01636947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC)
- NCT number
- NCT01636947
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 494 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Nausea, Vomiting
- Interventions
- Aprepitant, Aprepitant Placebo, Ondansetron, Dexamethasone, Ondansetron Placebo, Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).
- First posted
- 2012-07-10
- Last updated
- 2018-09-25
- Results first posted
- 2015-07-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants With No Vomiting - Overall Stage | Hour 0 on Day 1 to Day 5 (approximately 120 hours) | A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC). |
| Secondary | Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Hour 0 on Day 1 to Day 5 (approximately 120 hours) | A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. |
| Secondary | Number of Emetic Events - Overall Stage | Hour 0 on Day 1 to Day 5 (approximately 120 hours) | The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented. |
| Secondary | Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage | Days 1 to Day 5 | Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: "How much nausea have you had over the last 24 hours?" The left end of the scale (0 mm) was labeled "no nausea," and the right end of the scale (100 mm) is labeled "nausea as bad as it could be." In this study, No Significant Nausea was defined as a VAS nausea rating \<25 mm. |
| Secondary | Percentage of Participants With No Impact on Daily Life - Overall Stage | Day 6 | The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, "No Impact" on daily life was defined as an average item score of \>6 on the 7-point scale; a total score \>108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC. |
| Secondary | Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages | Day 1 to Day 5 | The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. |
| Secondary | Percentage of Participants With One or More Clinical Adverse Event | Day 1 through Day 29 (Up to 28 days after first dose of study drug) | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event. |
| Secondary | Percentage of Participants With No Vomiting - Acute and Delayed Stages | Day 1, Day 2 to Day 5 | A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants With No Vomiting - Overall Stage | Hour 0 on Day 1 to Day 5 (approximately 120 hours) | The modified intention-to-treat (mITT) population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Hour 0 on Day 1 to Day 5 (approximately 120 hours) | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Emetic Events - Overall Stage | Hour 0 on Day 1 to Day 5 (approximately 120 hours) | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Number of Emetic Events | NUMBER |
| SECONDARY | Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage | Days 1 to Day 5 | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With No Impact on Daily Life - Overall Stage | Day 6 | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug, had ≥1 post-treatment assessment on Day 1 and Day 2 and completed the FLIE questionnaire on Day 6. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages | Day 1 to Day 5 | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With One or More Clinical Adverse Event | Day 1 through Day 29 (Up to 28 days after first dose of study drug) | All randomized participants who received chemotherapy and took ≥1 dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With No Vomiting - Acute and Delayed Stages | Day 1, Day 2 to Day 5 | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants With No Vomiting - Overall Stage | Aprepitant Regimen | 77.2 | Percentage of Participants | ||
| The Percentage of Participants With No Vomiting - Overall Stage | Control Regimen | 72.0 | Percentage of Participants | ||
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Aprepitant Regimen | Overall Stage | 73.4 | Percentage of Participants | |
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Control Regimen | Overall Stage | 70.4 | Percentage of Participants | |
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Aprepitant Regimen | Acute Stage | 95.8 | Percentage of Participants | |
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Control Regimen | Acute Stage | 97.9 | Percentage of Participants | |
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Aprepitant Regimen | Delayed Stage | 74.3 | Percentage of Participants | |
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | Control Regimen | Delayed Stage | 71.2 | Percentage of Participants | |
| Number of Emetic Events - Overall Stage | Aprepitant Regimen | 54 | Number of Emetic Events | ||
| Number of Emetic Events - Overall Stage | Control Regimen | 68 | Number of Emetic Events |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aprepitant Regimen | 244 | |
| Overall Study | STARTED | Control Regimen | 250 | |
| Overall Study | Treated | Aprepitant Regimen | 242 | |
| Overall Study | Treated | Control Regimen | 248 | |
| Overall Study | COMPLETED | Aprepitant Regimen | 232 | |
| Overall Study | COMPLETED | Control Regimen | 239 | |
| Overall Study | NOT COMPLETED | Aprepitant Regimen | 12 | |
| Overall Study | NOT COMPLETED | Control Regimen | 11 |
Source ClinicalTrials.gov
Adverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Aprepitant Regimen | 10 | 242 | 10 |
| other | Constipation | Gastrointestinal disorders | Control Regimen | 22 | 248 | 22 |
| other | Diarrhoea | Gastrointestinal disorders | Aprepitant Regimen | 14 | 242 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Control Regimen | 17 | 248 | 17 |
| other | Nausea | Gastrointestinal disorders | Aprepitant Regimen | 20 | 242 | 20 |
| other | Nausea | Gastrointestinal disorders | Control Regimen | 20 | 248 | 20 |
| other | Neutrophil count decreased | Investigations | Aprepitant Regimen | 22 | 242 | 22 |
| other | Neutrophil count decreased | Investigations | Control Regimen | 21 | 248 | 21 |
| other | Decreased appetite | Metabolism and nutrition disorders | Aprepitant Regimen | 14 | 242 | 15 |
| other | Decreased appetite | Metabolism and nutrition disorders | Control Regimen | 15 | 248 | 15 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aprepitant Regimen | ||
| Total, all-cause mortality | Control Regimen | ||
| Total, other adverse events | Aprepitant Regimen | 87 | 242 |
| Total, other adverse events | Control Regimen | 96 | 248 |
| Total, serious adverse events | Aprepitant Regimen | 25 | 242 |
| Total, serious adverse events | Control Regimen | 16 | 248 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27826874 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aprepitant Regimen vs Control Regimen: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01636947
GET https://conductscience.org/api/trials/v1/NCT01636947/results?page=2