Trial · NCT00619359
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
NCT00619359, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017). Trials, record NCT00619359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00619359
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
- NCT number
- NCT00619359
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,322 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- Interventions
- Comparator: fosaprepitant dimeglumine, Comparator: Aprepitant, Dexamethasone, Dexamethasone, Ondansetron
- First posted
- 2008-02-21
- Last updated
- 2017-03-21
- Results first posted
- 2010-02-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). | Overall (in the 120 hours following initiation of cisplatin chemotherapy). | The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy. |
| Secondary | A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). | Delayed phase (25 to 120 hours following initiation of cisplatin). | The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy. |
| Secondary | No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) | Overall (the 120 hours following initiation of cisplatin chemotherapy) | The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). | Overall (in the 120 hours following initiation of cisplatin chemotherapy). | FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. | Participants | NUMBER |
| SECONDARY | A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). | Delayed phase (25 to 120 hours following initiation of cisplatin). | FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis. | Participants | NUMBER |
| SECONDARY | No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) | Overall (the 120 hours following initiation of cisplatin chemotherapy) | FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). | Fosaprepitant | 795 | Participants | ||
| A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). | Aprepitant | 820 | Participants | ||
| A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). | Fosaprepitant | 822 | Participants | ||
| A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). | Aprepitant | 841 | Participants | ||
| No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) | Fosaprepitant | 806 | Participants | ||
| No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) | Aprepitant | 844 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fosaprepitant | 1,147 | |
| Overall Study | STARTED | Aprepitant | 1,175 | |
| Overall Study | COMPLETED | Fosaprepitant | 1,080 | |
| Overall Study | COMPLETED | Aprepitant | 1,094 | |
| Overall Study | NOT COMPLETED | Fosaprepitant | 67 | |
| Overall Study | NOT COMPLETED | Aprepitant | 81 |
Source ClinicalTrials.gov
Adverse events368
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 | Anaemia | Blood and lymphatic system disorders | Fosaprepitant | 17 | 1,143 | |
| other | Anaemia | Blood and lymphatic system disorders | Aprepitant | 7 | 1,169 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fosaprepitant | 14 | 1,143 | |
| other | Leukopenia | Blood and lymphatic system disorders | Aprepitant | 16 | 1,169 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fosaprepitant | 28 | 1,143 | |
| other | Neutropenia | Blood and lymphatic system disorders | Aprepitant | 25 | 1,169 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Fosaprepitant | 17 | 1,143 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Aprepitant | 14 | 1,169 | |
| other | Tinnitus | Ear and labyrinth disorders | Fosaprepitant | 19 | 1,143 | |
| other | Tinnitus | Ear and labyrinth disorders | Aprepitant | 10 | 1,169 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fosaprepitant | ||
| Total, all-cause mortality | Aprepitant | ||
| Total, other adverse events | Fosaprepitant | 636 | 1,143 |
| Total, other adverse events | Aprepitant | 679 | 1,169 |
| Total, serious adverse events | Fosaprepitant | 148 | 1,143 |
| Total, serious adverse events | Aprepitant | 157 | 1,169 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21383291 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fosaprepitant vs Aprepitant: No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) | Trial comparisons |
| Fosaprepitant vs Aprepitant: A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). | Trial comparisons |
| Fosaprepitant vs Aprepitant: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). | Trial comparisons |
| Fosaprepitant vs Aprepitant: serious adverse events | 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/NCT00619359
GET https://conductscience.org/api/trials/v1/NCT00619359/events?page=2