Trial · NCT02603172
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 51
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 14 | An AE is any untoward medical occurrence in a participants or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization clinical chemor prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. Safety population consist of all participants who received at least one dose of the study medication. |
| Primary | Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria | Day 1 | PCI ranges for the clinical chemistry parameters were as follows : albumin (low: \<0.86 gram \[g\] per liter \[L\]), calcium (low: \<0.91 millimole \[mmol\]/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total carbon dioxide (CO2) (low: \<0.86 mmol/L and high: \>1.14 mmol/L). |
| Primary | Part A: Number of Participants With Emergent Hematology by PCI Criteria | Day 1 | PCI ranges for the hematology parameters were as follows: white blood cell (WBC) count (low: \<0.67 10\^9 cells/L and high: \>1.82 10\^9 cells/L), neutrophil count (low: \<0.83 10\^9 cells/L), hemoglobin (high: \>1.03 g/L in male, \>1.13 g/L in female), hemocrit (high: \>1.02 proportion of red blood cell \[RBC\] in blood for male, \>1.17 proportion of RBC in blood for female), platelet count (low: \<0.67 10\^9 cells/L and high: 1.57 10\^9 cells/L), and lymphocytes (low: \<0.81 10\^9 cells/L). |
| Primary | Part A: Number of Participants With Abnormal Urinalysis Data by Dipstick | Day 1 | Urine samples were collected and urinalysis included analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner. |
| Primary | Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Triplicate ECG was measured in semi-supine position after 5 minutes (min) rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part A: Mean Change From Baseline in Heart Rate by 12-lead ECG | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Triplicate ECG was measured in semi-supine position after 5 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures the heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part A: Mean Change From Baseline in Blood Pressure (BP) | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Systolic BP and diastolic BP were measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part A: Mean Change From Baseline in Pulse Rate | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part A: Mean Change From Baseline in Temperature | Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose | Temperature was measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part B:Number of Participants With AEs and SAEs | Cohort 3: Up to Day 21; Cohort 4: Up to Day 35 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. |
| Primary | Part B: Number of Participants With Emergent Clinical Chemistry by PCI Criteria | Cohort 3 and 4: Up to Day 3 | PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<0.86 g/L), calcium (low: \<0.91 mmol/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total CO2 (low: \<0.86 mmol/L and high: \>1.14 mmol/L). |
| Primary | Part B: Number of Participants With Emergent Hematology by PCI Criteria | Cohort 3 and 4: Up to Day 3 | PCI ranges for the hematology parameters were as follows: WBC count (low: \<0.67 10\^9 cells/L and high: \>1.82 10\^9 cells/L), neutrophil count (low: \<0.83 10\^9 cells/L), hemoglobin (high: \>1.03 g/L in male, \>1.13 g/L in female), hemocrit (high: \>1.02 proportion of RBC in blood for male, \>1.17 proportion of RBC in blood for female), platelet count (low: \<0.67 10\^9 cells/L and high: 1.57 10\^9 cells/L), and lymphocytes (low: \<0.81 10\^9 cells/L). |
| Primary | Part B: Number of Participants With Abnormal Urinalysis Data by Dipstick | Cohort 3 and 4: Up to Day 3 | Urine samples were collected and urinalysis included analysis of specific gravity, pH, glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner. |
| Primary | Part B: Mean Change From Baseline in 12-lead ECG | Cohort 3: Baseline (pre-dose), Day 1 (1 hour), Days 2, 3, 4, 5, 6, 7 (pre-dose and 1 hour), 8 and 21; Cohort 4: Up to Day 35 | Triplicate ECG was measured in semi-supine position after 5 minutes rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the latest available assessment pre the first dose of study drug in Part B. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part B: Mean Change From Baseline in Heart Rate by 12-lead ECG | Cohort 3: Baseline (pre-dose), Day 1 (1 hour), Days 2, 3, 4, 5, 6, 7 (pre-dose and 1 hour), 8 and 21; Cohort 4: Up to Day 35 | Triplicate ECG was measured in semi-supine position after 5 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part B. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. |
| Primary | Part B: Number of Participants With Abnormal Cardiac Telemetry Findings | Cohort 3: Up to Day 8 | The cardiac monitoring was measured by using an appropriate nonimplantable recording device which is acceptable to the participants. This was evaluated the arrhythmic background of eligible cardiac amyloidosis participants such that false positive attribution of arrhythmias to GSK3039294 during repeat dosing was minimized. |
| Primary | Part C: Number of Participants With AEs and SAEs | Up to Day 63 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. This analysis was planned but not performed for Part C as the study was terminated early during Part B. |
| Primary | Part C: Number of Participants With Emergent Clinical Chemistry by PCI Criteria | Up to Day 63 | PCI parameters for the clinical chemistry that were planned for analysis are as follows: albumin, calcium, glucose, magnesium, phosphorous , potassium , sodium , and total CO2. This analysis was planned but not performed for Part C as the study was terminated early during Part B. |
| Primary | Part C: Number of Participants With Emergent Hematology Parameters by PCI Criteria | Up to Day 63 | Hematology parameters that were planned for analysis were as follows: WBC count , neutrophil count , hemoglobin , hemocrit , platelet count , and lymphocytes. This analysis was planned but not performed for Part C as the study was terminated early during Part B. |
| Primary | Part C: Number of Participants With Emergent Urinalysis Parameters by PCI Criteria | Up to Day 63 | Urine samples were planned to be collected and urinalysis included analysis of specific gravity, pH, glucose, protein, blood, ketones by dipstick. This analysis was planned but not performed for Part C as the study was terminated early during Part B. |
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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