Trial · NCT04292912
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Abnormal Ophthalmic Examination Findings | Up to Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline to Day 28 in Visual Acuity | Baseline and Day 28 | Pharmacodynamics (PD) analysis set included all participants from the modified Safety population who had at least 1 post-baseline non-missing PD assessment. | Letters | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Body Weight | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | kilogram (kg) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Body Temperature | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Degree Celsius (°C) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Vital Signs for Systolic Blood Pressure and Diastolic Blood Pressure | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | mmHg | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Pulse Rate | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Beats per Minute (beats/min) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in 12-lead Electrocardiogram (ECG) Findings | Baseline and Day 28 | The intensive pharmacokinetics (PK) analysis population included all participants from the modified Safety population who had intensive PK sampling on Day 7 and Day 28. However, since only one participant consented to intensive PK and this participant withdrew early, before Day 28, data for this endpoint were not collected. | ||
| PRIMARY | Mean Change From Baseline to Day 28 in Alanine Amino Transferase (ALT), Alkaline Phosphatase (AP), Aspartate Amino Transferase (AST), and Creatine Kinase | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Microkatal per Litre (ukat/L) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Calcium, Glucose, Potassium, Sodium, and Urea Nitrogen | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Millimoles per Liter (mmol/L) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Creatinine, Total Bilirubin, and Direct Bilirubin | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Micromoles per Liter (umol/L) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Protein | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Grams per Liter (g/L) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Clinical Chemistry Parameter Values of Cardiac Troponin | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Basophils, Eosinophils, Leukocytes, Monocytes, Lymphocytes, Neutrophils, and Platelets | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Giga (10^9) cells per liter | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | g/L | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Mean Corpuscular Hemoglobin | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Picograms per cell (pg/cell) | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Mean Corpuscular Volume (MCV) | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Femtoliter | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Erythrocytes | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | 10^12 cells per Liter | MEAN |
| PRIMARY | Mean Change From Baseline to Day 28 in Hematocrit | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Proportion of red blood cells in blood | MEAN |
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Ocular and Non-ocular AEs and SAEs | Until follow-up (Up to Day 56) | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline to Day 28 in Center Subfield Retinal Thickness as Measured by Spectral-Domain Optical Coherence Tomography (SD-OCT) | Baseline and Day 28 | Modified safety population comprised of all participants who received at least one dose of study treatment. Only those participants available at the time of assessment were analyzed. | Micrometer (um) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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GET https://conductscience.org/api/trials/v1/NCT04292912/outcomes