Trial · NCT01594749
Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)
NCT01594749, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2015-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031). Trials, record NCT01594749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01594749
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)
- NCT number
- NCT01594749
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,015 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- Interventions
- Fosaprepitant dimeglumine, Fosaprepitant Placebo, Dexamethasone, Ondansetron, Dexamethasone Placebo, Ondansetron Placebo, Rescue Therapy
- First posted
- 2012-05-09
- Last updated
- 2018-09-04
- Results first posted
- 2015-09-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) | 25 to 120 hours after initiation of MEC | A Complete Response was defined as no vomiting and no use of rescue medication. |
| Primary | Percentage of Participants With Infusion-site Thrombophlebitis | Day 1 through Day 17, inclusive | 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. |
| Primary | Percentage of Participants With Severe Infusion-site Reactions | Day 1 through Day 17, inclusive | 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. |
| Secondary | Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC | 0 to 120 hours after initiation of MEC | A Complete Response was defined as no vomiting and no use of rescue medication. |
| Secondary | Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC | 0 to 24 hours after initiation of MEC | A Complete Response was defined as no vomiting and no use of rescue medication. |
| Secondary | Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) | 25 to 120 hours after initiation of MEC | 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. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Infusion-site Thrombophlebitis | Day 1 through Day 17, inclusive | The Safety population consisted of all randomized participants who received study drug as treated. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Severe Infusion-site Reactions | Day 1 through Day 17, inclusive | The Safety population consisted of all randomized participants who received study drug as treated. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC | 0 to 120 hours after initiation of MEC | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC | 0 to 24 hours after initiation of MEC | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC | 0 to 120 hours after initiation of MEC | 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. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) | Fosaprepitant Regimen | 78.9 | Percentage of Participants | ||
| Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) | Control Regimen | 68.5 | Percentage of Participants | ||
| Percentage of Participants With Infusion-site Thrombophlebitis | Fosaprepitant Regimen | 0.6 | Percentage of Participants | ||
| Percentage of Participants With Infusion-site Thrombophlebitis | Control Regimen | 0.0 | Percentage of Participants | ||
| Percentage of Participants With Severe Infusion-site Reactions | Fosaprepitant Regimen | 0.0 | Percentage of Participants | ||
| Percentage of Participants With Severe Infusion-site Reactions | Control Regimen | 0.0 | Percentage of Participants | ||
| Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC | Fosaprepitant Regimen | 77.1 | Percentage of Participants | ||
| Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC | Control Regimen | 66.9 | Percentage of Participants | ||
| Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC | Fosaprepitant Regimen | 93.2 | Percentage of Participants | ||
| Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC | Control Regimen | 91.0 | Percentage of Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fosaprepitant Regimen | 507 | |
| Overall Study | STARTED | Control Regimen | 508 | |
| Overall Study | Treated | Fosaprepitant Regimen | 503 | |
| Overall Study | Treated | Control Regimen | 498 | |
| Overall Study | COMPLETED | Fosaprepitant Regimen | 485 | |
| Overall Study | COMPLETED | Control Regimen | 490 | |
| Overall Study | NOT COMPLETED | Fosaprepitant Regimen | 22 | |
| Overall Study | NOT COMPLETED | Control Regimen | 18 |
Source ClinicalTrials.gov
Adverse events128
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 | Neutropenia | Blood and lymphatic system disorders | Fosaprepitant Regimen | 38 | 504 | 38 |
| other | Neutropenia | Blood and lymphatic system disorders | Control Regimen | 33 | 497 | 33 |
| other | Constipation | Gastrointestinal disorders | Fosaprepitant Regimen | 47 | 504 | 48 |
| other | Constipation | Gastrointestinal disorders | Control Regimen | 51 | 497 | 53 |
| other | Diarrhoea | Gastrointestinal disorders | Fosaprepitant Regimen | 63 | 504 | 66 |
| other | Diarrhoea | Gastrointestinal disorders | Control Regimen | 55 | 497 | 57 |
| other | Fatigue | General disorders | Fosaprepitant Regimen | 75 | 504 | 78 |
| other | Fatigue | General disorders | Control Regimen | 64 | 497 | 64 |
| other | Decreased appetite | Metabolism and nutrition disorders | Fosaprepitant Regimen | 26 | 504 | 27 |
| other | Decreased appetite | Metabolism and nutrition disorders | Control Regimen | 32 | 497 | 32 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fosaprepitant Regimen | ||
| Total, all-cause mortality | Control Regimen | ||
| Total, other adverse events | Fosaprepitant Regimen | 190 | 504 |
| Total, other adverse events | Control Regimen | 193 | 497 |
| Total, serious adverse events | Fosaprepitant Regimen | 39 | 504 |
| Total, serious adverse events | Control Regimen | 35 | 497 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Fosaprepitant 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/NCT01594749
GET https://conductscience.org/api/trials/v1/NCT01594749/events?page=2