Trial · NCT04003155
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 | Baseline and week 4 | Full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of study intervention. The randomized treatment for each participant was used for summaries by treatment group based on the FAS, even if a participant erroneously received a different treatment. Participants with available data at specified time point were included. | VMS per day | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12 | Baseline and week 12 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4 | Baseline and week 4 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12 | Baseline and week 12 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b) Total Score at Week 12 | Baseline and week 12 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Frequency of Moderate, and Severe VMS to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11 | FAS population with available data at specified time point. | VMS per day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in The Mean Severity of Moderate, and Severe VMS to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 5, 6, 7, 8, 9, 10 and 11 | FAS population with available data at specified time point. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change in The Frequency of Moderate And Severe VMS From Baseline to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | FAS population with available data at specified time point. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Percent Reduction of >=50% in the Mean Frequency of Moderate and Severe VMS From Baseline to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | FAS Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate, and Severe VMS From Baseline to Each Study Week Up to Week 12 | Baseline and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 | FAS Population | Participants | NUMBER |
| SECONDARY | Number of Participants in Each Category of Patient's Global Impression of Change (PGIC) in VMS at Each Visit | Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 48, 52 of fezolinetant exposure (weeks 16, 24, 28, 32, 36, 40, 44, 48 and 52 for arms Placebo/Fezolinetant 30 mg and Placebo/Fezolinetant 45 mg) | FAS population with available data at specified time point. | Participants | NUMBER |
| SECONDARY | Change From Baseline in The Mean Frequency of Moderate, and Severe VMS at Week 24 | Baseline and 24 weeks of fezolinetant exposure (week 36 for arms Placebo/Fezolinetanat 30 mg and Placebo/Fezolinetant 45 mg) | FAS population with available data at specified time point. | VMS per day | MEAN |
| SECONDARY | Change From Baseline in The Mean Severity of Moderate, and Severe VMS at Week 24 | Baseline and 24 weeks of fezolinetant exposure (week 36 for arms Placebo/Fezolinetanat 30 mg and Placebo/Fezolinetant 45 mg) | FAS population with available data at specified time point. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | From first dose date up to 21 days after last dose (to 55 weeks) | Safety population included all randomized participants who took at least 1 dose of study intervention. A participant erroneously receiving a treatment different from their randomized treatment was assigned to the treatment group that the participant received as first dose. | Participants | NUMBER |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04003155/outcomes