Trial · NCT01668654
Outcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | From the start of study medication until the end of Follow-Up (up to 178 days) | All Subjects Population: all participants who enrolled in the study. | Participants | NUMBER |
| PRIMARY | Number of Participants With AEs Leading to Withdrawal | From the start of study medication until the end of the Follow-Up Visit (up to 178 days) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study | Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Change From Baseline in SBP and DBP at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Heart Rate at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Temperature at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Height at Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Weight at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Number of Participants With Abnormal Clinically Significant ECG Findings Based on Investigator Judgment at Anytime During the Study | Eligibility Assessment and EW Visit | All Subjects Population | Participants | NUMBER |
| PRIMARY | Change From Baseline in ALT, ALP, AST, CK, and LDH Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorus, Potassium, Sodium, and Urea/BUN Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid, and Urine Creatinine Concentration Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and White Blood Cell Count Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and Red Cell Distribution Width (RDW) Percentages at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in the Hematocrit Measurements at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population |
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/NCT01668654/outcomes