Trial · NCT03287310
Outcomes59
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 59
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | Up to Week 40 | Safety Population comprised of all randomized participants who received at least one dose of the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Special Interest (AESI) | Up to Week 40 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Giga cells per liter | MEAN |
| PRIMARY | Change From Baseline in Red Blood Cell Count (RBC) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Trillion cells per liter | MEAN |
| PRIMARY | Change From Baseline in Mean Corpuscle Volume (MCV) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Femtoliters | MEAN |
| PRIMARY | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Picograms | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Grams per liter | MEAN |
| PRIMARY | Change From Baseline in Hematocrit | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Proportion of red blood cells in blood | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Milligrams per liter | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Grams per liter | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Micromoles per liter | MEAN |
| PRIMARY | Urine Specific Gravity Analysis by Dipstick Method | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Ratio | MEAN |
| PRIMARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Millimeters of mercury | MEAN |
| PRIMARY | Change From Baseline in Temperature | Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Degree Celsius | MEAN |
| PRIMARY | Change From Baseline in Heart Rate | Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Beats per minute | MEAN |
| PRIMARY | Change From Baseline in Respiration Rate | Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Breaths per minute | MEAN |
| PRIMARY | Change From Baseline in Heart Rate: Electrocardiogram (ECG) | Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Beats per minute | MEAN |
| PRIMARY | Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval | Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Milliseconds | MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg | Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose | Pharmacokinetic Population. | Day*microgram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | AUC(0-inf) of GSK3511294 30 mg and 100 mg | Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose | Pharmacokinetic Population. | Day*microgram per milliliter | GEOMETRIC_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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