Trial · NCT01919697
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 72 weeks | All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE. |
| 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 | Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug |
| Primary | Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of Vital Signs at >Day 364 - Body Temperature (°C) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of ECG Results Shift From Baseline at > Day 364 | From first dose up to 72 weeks | Baseline was defined as the last non-missing value collected prior to first dose of study drug) |
| Primary | Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | From first dose up to 72 weeks | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE. |
| Secondary | Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 | Form first dose up to 72 weeks | Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. |
| Secondary | Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 | From first dose up to 72 weeks | Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. |
| Secondary | Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 | From first dose up to 72 weeks | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied. |
| Secondary | Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment | From first dose up to 72 weeks | Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely |
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.
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GET https://conductscience.org/api/trials/v1/NCT01919697/registered