Trial · NCT01919697
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 72 weeks | The Safety Population consisted of all enrolled patients who had received at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | From first dose up to 72 weeks | The Safety Population consisted of all enrolled patients who had at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | mmHg | MEAN |
| PRIMARY | Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | beats per minute | MEAN |
| PRIMARY | Summary of Vital Signs at >Day 364 - Body Temperature (°C) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | °C | MEAN |
| PRIMARY | Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | breaths per minute | MEAN |
| PRIMARY | Summary of ECG Results Shift From Baseline at > Day 364 | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | participants | NUMBER |
| PRIMARY | Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | participants | NUMBER |
| SECONDARY | Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 | Form first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | score on a scale | MEAN |
| SECONDARY | Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 | From first dose up to 72 weeks | All enrolled patients who had at least one dose of the study drug and had at least one post-baseline Patient Global Assessment (PGA) were included in this population. A total of 2378 patients including the re-enrolled patients who previously participated and completed this open-label study was used for assessments. | score on a scale | MEAN |
| SECONDARY | Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | score on a scale | MEAN |
| SECONDARY | Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | score on a scale | MEAN |
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/NCT01919697/outcomes