Trial · NCT02646566
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response (Success of Initial PONV Treatment) | 0-24 hours after administration of study medication | The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication. |
| Secondary | Number of Participants With Complete Response 0-2 Hrs | 0-2 hours after administration of study medication | Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication. |
| Secondary | Number of Participants With Complete Response 0-4 Hrs | 0-4 hours after administration of study medication | Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication. |
| Secondary | Number of Participants With Complete Response 0-6 Hrs | 0-6 hours after administration of study medication | Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period after administration of study medication. |
| Secondary | Time to Treatment Failure | 0-24 hours after study drug administration | Time to first violation of the criteria for complete response |
| Secondary | Number of Patients With Incidence of Emesis | 30 mins to 24 hours after study drug administration | Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication |
| Secondary | Number of Patients Receiving Rescue Medication | 0-24 hours after study drug administration | Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period |
| Secondary | Number of Patients With an Incidence of Significant Nausea | 30 mins to 24 hours after study drug administration | Number of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication. |
| Secondary | Number of Patients With an Incidence of Nausea | 30 mins to 24 hours after drug administration | Number of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication. |
| Secondary | Maximum Severity of Nausea | 30 mins to 24 hours after study drug administration | Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication. |
| Secondary | Evolution Score of Nausea (0-180 Mins) | 0-180 minutes after study drug administration | The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at five pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes and 2 hours after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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