Trial · NCT02914314
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Core Phase and Extension Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Core Phase: From the first dose of study drug up to 4 weeks of follow up after the last dose in Core Phase (up to Week 24); Extension Phase: From end of Core Phase treatment up to 4 weeks of follow up after the last dose in Extension Phase (up to Week 56) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, and Platelets | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM and number analyzed signifies participants who were evaluable for specified categories. | 10^9 cells/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Erythrocytes | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | 10^12 cells/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Hematology Laboratory Parameter: Hemoglobin | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | g/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | U/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameter: Bilirubin | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mcmol/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM and number analyzed signifies participants who were evaluable for specified categories. | mmol/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Creatinine, Direct Bilirubin, Urate | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mcmol/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Clinical Chemistry Laboratory Parameters: Albumin, Globulin, Protein | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | g/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mmHg | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Pulse Rate | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | beats/min | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Respiratory Rate | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | breaths/min | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Vital Sign Parameter: Body Temperature | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | degree centigrade | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Height | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | centimeters | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Weight | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | kilograms | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Head Circumference | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | centimeters | MEAN |
| SECONDARY | Core and Extension Phase: Mean Change From Baseline in ECG Parameters: Single Beat Heart Rate-corrected QT Interval (QTcB), QT Interval Corrected According to the Formula of Fridericia (QTcF), PR and QT Intervals, QRS Duration, and Aggregate RR Interval | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM and number analyzed signifies participants who were evaluable for specified categories. | msec | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in ECG Parameter: ECG Ventricular Rate | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | beats/min | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Thyroid Stimulating Hormone (TSH): Thyrotropin | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mIU/L | MEAN |
| SECONDARY | Core Phase and Extension Phase: Mean Change From Baseline in Insulin-like Growth Factor 1 (IGF-1) | Core Phase: Baseline, end of Core Phase treatment (up to Week 20); Extension Phase: Baseline (Core Phase), end of Extension Phase treatment (Week 52) | The SAS was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. Here, overall number of participants analyzed signifies participants who were evaluable for this OM. | mmol/L*10^-6 | 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.
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