Macular Degeneration
Conditions
Keywords
age-related macular degeneration (AMD), choroidal neovascularization (CNV), vascular endothelial growth factor (VEGF), pazopanib, angiogenesis
Brief summary
This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.
Interventions
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects who participated in Phase IIa study MD7108240 and who did not experience AMD disease progression requiring rescue therapy during pazopanib treatment or require discontinuation of pazopanib eye drops for safety reasons * Best-corrected ETDRS visual acuity in the study eye of 23 letters (20/320 or 4/63) or better at screening. * QTcB or QTcF \< 450msec; or QTc \< 480msec in subjects with Bundle Branch Block. * Subject is willing and able to return for all study visits, and is willing and able to comply with all protocol requirements and procedures. * Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is unable to read the consent form due to visual impairment then the consent must be read to the subject verbatim by person administering the consent, a family member or legally acceptable representative. If the subject is unable to provide written informed consent due to visual impairment, then written informed consent on behalf of the subject must be provided by a legally acceptable representative. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)
Exclusion criteria
* Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT. * Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD. * Intraocular surgery in the study eye within 3 months of dosing. * Use of topical ocular medications (other than pazopanib) in the study eye within 7 days of first dose of investigational product or expected use of topical ocular medications during the treatment period, with the exception of artificial tears. * Current use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol). * An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit * ALT or AST above the upper limit of normal or total bilirubin ≥ 1.5 times the upper limit of normal at baseline. Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator. * Medical history or condition: * Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) \> 10%. * Myocardial infarction or stroke within 6 months of screening. * Active bleeding disorder. * Major surgery within 1 month of screening. * Hepatic impairment. * Uncontrolled hypertension, based on criteria provided in the protocol. Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met. * Use of prohibited medications listed in the protocol within the restricted timeframe relative to the first dose of study medication. * A condition or situation which, in the opinion of the investigator, may result in significant risk to the subject, confound the study results or interfere significantly with participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal (Dilated) Fundus Examination | Approximately up to 6 months | Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA. |
| Number of Participants With Abnormal Corneal Examination of PCI | Approximately up to 6 months | A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (\<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period). |
| Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale | Approximately up to 6 months | A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma. |
| Number of Participants With Abnormal Tear Films of PCI | Approximately up to 6 months | Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes. |
| Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function | Approximately up to 6 months | Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI. |
| Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was \<80 or \>140 mm Hg and DBP was \<40 or \>90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour. |
| Change From Baseline (Day 1) in Heart Rate Over Period | Baseline (Day 1) and approximately up to 6 months | Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range \< 50 beats per minute (bpm) or \>110 bpm. |
| Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Baseline (Day 1), Month 2, 5 and approximately up to Month 6 | Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. |
| Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | Baseline (Day 1) and approximately up to 6 months | ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. |
| Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months. |
| Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months. |
| Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months |
| Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up. |
| Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up. |
| Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Baseline (Day 1) and approximately up to 6 months | Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up. |
| Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Approximately up to 6 months (up to follow-up) | In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). |
| Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Approximately up to 6 months | Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. |
| Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI) | Approximately up to 6 months | Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented. |
| Number of Participants With Abnormal Pupil Examination of PCI | Up to follow-up (approximately 6 months) | Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined. |
| Number of Participants With Abnormal Conjunctival Examination of PCI | Up to follow-up (approximately 6 months) | A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months). |
| Number of Participants With Abnormal Anterior Chamber Examination of PCI | Approximately up to 6 months | A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | From Baseline (Screening visit) and up to 5 months | The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5. |
| Change in Neo-vascular Size and Lesion Size Over Period | Up to 6 weeks | The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure. |
| Number of Participants With Lesion Types Over Period | Up to 6 months | Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported. |
| Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | From Baseline (screening visit), Month 2, and Month 5 | Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5. |
Countries
Australia, Italy, United States
Participant flow
Recruitment details
This was an extension study to protocol MD7108240 (NCT00612456). It was a multi-center, double-masked, randomized, parallel-group dose-ranging study of repeat topical ocular doses of pazopanib from 25 June 2008 to 9 September 2009. The study was conducted in 14 centers in the United States, Italy, and Australia.
Pre-assignment details
Randomized participants without progression of age-related macular degeneration (AMD) and/or requiring rescue therapy during the 28-day treatment period in study MD7108240 (NCT00612456) were included in this study. A total of 42 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| 5 mg/mL TID Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months. | 19 |
| 2 mg/mL TID Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months. | 15 |
| 5 mg/mL QD Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months. | 8 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Physician Decision | 3 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | 5 mg/mL TID | 2 mg/mL TID | 5 mg/mL QD | Total |
|---|---|---|---|---|
| Age, Customized 55 to 88 aged | 19 Participants | 15 Participants | 8 Participants | 42 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 15 Participants | 8 Participants | 42 Participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 5 Participants | 27 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 3 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 15 | 0 / 8 |
| other Total, other adverse events | 15 / 19 | 9 / 15 | 3 / 8 |
| serious Total, serious adverse events | 2 / 19 | 1 / 15 | 0 / 8 |
Outcome results
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.
Time frame: Baseline (Day 1), Month 2, 5 and approximately up to Month 6
Population: Safety population. Only the participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Month 2 | 0.6 Grams per liter | Standard Deviation 1.46 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Month 5 | -0.2 Grams per liter | Standard Deviation 10.04 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Follow-up | -0.4 Grams per liter | Standard Deviation 1.67 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Month 2 | 2.1 Grams per liter | Standard Deviation 6.95 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Follow-up | -0.2 Grams per liter | Standard Deviation 8.65 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Month 5 | 0.3 Grams per liter | Standard Deviation 2.15 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Follow-up | -1.1 Grams per liter | Standard Deviation 1.45 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Month 2 | -0.5 Grams per liter | Standard Deviation 4.22 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Month 2 | -0.7 Grams per liter | Standard Deviation 1.38 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Month 5 | -1.0 Grams per liter | Standard Deviation 1.34 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Month 5 | 0.3 Grams per liter | Standard Deviation 5.05 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Follow-up | 0.4 Grams per liter | Standard Deviation 8.66 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Month 5 | -3.0 Grams per liter | Standard Deviation 1 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Follow-up | 2.5 Grams per liter | Standard Deviation 5.26 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Month 5 | -6.0 Grams per liter | Standard Deviation 0 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Month 2 | -1.1 Grams per liter | Standard Deviation 1.96 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Albumin, Follow-up | 0.2 Grams per liter | Standard Deviation 1.3 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period | Hemoglobin, Month 2 | -1.3 Grams per liter | Standard Deviation 8.35 |
Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period
Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only the participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Basophils, Month 5 | 0.007 Giga per Liter (G/L) | Standard Deviation 0.0237 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Basophils, Month 2 | 0.008 Giga per Liter (G/L) | Standard Deviation 0.0246 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Bsophils, Follow-up | 0.010 Giga per Liter (G/L) | Standard Deviation 0.0234 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils, Month 2 | -0.043 Giga per Liter (G/L) | Standard Deviation 0.1604 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils, Month 5 | 0.034 Giga per Liter (G/L) | Standard Deviation 0.0952 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils,Follow-up | 0.046 Giga per Liter (G/L) | Standard Deviation 0.1623 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Month 2 | 0.077 Giga per Liter (G/L) | Standard Deviation 0.8534 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Month 5 | -0.004 Giga per Liter (G/L) | Standard Deviation 0.5848 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Follow-up | -0.058 Giga per Liter (G/L) | Standard Deviation 0.4984 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Month 2 | 0.025 Giga per Liter (G/L) | Standard Deviation 0.1304 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Month 5 | 0.006 Giga per Liter (G/L) | Standard Deviation 0.2047 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Follow-up | -0.035 Giga per Liter (G/L) | Standard Deviation 0.1506 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Month 2 | -1.1 Giga per Liter (G/L) | Standard Deviation 21.84 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Month 5 | 1.3 Giga per Liter (G/L) | Standard Deviation 33.83 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Follow-up | -3.3 Giga per Liter (G/L) | Standard Deviation 22.5 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Month 2 | -0.42 Giga per Liter (G/L) | Standard Deviation 1.986 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Month 5 | -1.41 Giga per Liter (G/L) | Standard Deviation 2.938 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Follow-up | -0.89 Giga per Liter (G/L) | Standard Deviation 2.614 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Follow-up | 0.76 Giga per Liter (G/L) | Standard Deviation 2.558 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Basophils, Month 5 | 0.006 Giga per Liter (G/L) | Standard Deviation 0.0168 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils, Month 2 | 0.010 Giga per Liter (G/L) | Standard Deviation 0.1204 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Month 2 | 0.025 Giga per Liter (G/L) | Standard Deviation 0.1621 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Month 2 | 1.3 Giga per Liter (G/L) | Standard Deviation 21.39 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Basophils, Month 2 | 0.008 Giga per Liter (G/L) | Standard Deviation 0.0157 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Follow-up | -7.3 Giga per Liter (G/L) | Standard Deviation 19.31 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Month 2 | -0.02 Giga per Liter (G/L) | Standard Deviation 1.027 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Month 5 | 0.036 Giga per Liter (G/L) | Standard Deviation 0.1272 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Bsophils, Follow-up | -0.003 Giga per Liter (G/L) | Standard Deviation 0.0142 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Follow-up | 0.090 Giga per Liter (G/L) | Standard Deviation 0.3412 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Month 5 | -0.00 Giga per Liter (G/L) | Standard Deviation 1.484 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Month 5 | -10.9 Giga per Liter (G/L) | Standard Deviation 15.48 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils, Month 5 | -0.009 Giga per Liter (G/L) | Standard Deviation 0.1324 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Month 5 | 0.068 Giga per Liter (G/L) | Standard Deviation 0.2245 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Follow-up | 0.002 Giga per Liter (G/L) | Standard Deviation 0.1293 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils,Follow-up | 0.007 Giga per Liter (G/L) | Standard Deviation 0.1083 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Month 2 | 0.051 Giga per Liter (G/L) | Standard Deviation 0.4203 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils,Follow-up | 0.032 Giga per Liter (G/L) | Standard Deviation 0.0613 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Month 2 | -0.031 Giga per Liter (G/L) | Standard Deviation 0.3855 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Month 5 | 0.130 Giga per Liter (G/L) | Standard Deviation 0.3536 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Follow-up | 8.3 Giga per Liter (G/L) | Standard Deviation 7.5 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Lymphocytes, Follow-up | 0.062 Giga per Liter (G/L) | Standard Deviation 0.1959 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Follow-up | -0.07 Giga per Liter (G/L) | Standard Deviation 2.251 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Month 2 | 0.020 Giga per Liter (G/L) | Standard Deviation 0.1812 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Month 5 | -0.015 Giga per Liter (G/L) | Standard Deviation 0.1202 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Month 2 | 0.26 Giga per Liter (G/L) | Standard Deviation 1.334 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Monocytes, Follow-up | 0.030 Giga per Liter (G/L) | Standard Deviation 0.0942 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils, Month 2 | -0.088 Giga per Liter (G/L) | Standard Deviation 0.1784 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Basophils, Month 2 | -0.003 Giga per Liter (G/L) | Standard Deviation 0.0271 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Basophils, Month 5 | -0.010 Giga per Liter (G/L) | Standard Deviation 0.0141 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Month 2 | 11.9 Giga per Liter (G/L) | Standard Deviation 29.3 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Bsophils, Follow-up | 0.00 Giga per Liter (G/L) | Standard Deviation 0 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Eosinophils, Month 5 | 0.030 Giga per Liter (G/L) | Standard Deviation 0.1131 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | Platelets, Month 5 | 70.0 Giga per Liter (G/L) | Standard Deviation 62.23 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period | White blood cells, Month 5 | 0.50 Giga per Liter (G/L) | Standard Deviation 1.697 |
Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period
Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only those participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Follow-up | -0.1 Micromoles per Liter (umol/L) | Standard Deviation 1 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 3 | -0.1 Micromoles per Liter (umol/L) | Standard Deviation 0.64 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 5 | -0.7 Micromoles per Liter (umol/L) | Standard Deviation 2.28 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 1 | -0.7 Micromoles per Liter (umol/L) | Standard Deviation 3.98 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 2 | 0.2 Micromoles per Liter (umol/L) | Standard Deviation 0.92 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 4 | -0.3 Micromoles per Liter (umol/L) | Standard Deviation 2.02 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 2 | 0.3 Micromoles per Liter (umol/L) | Standard Deviation 1.78 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Month 2 | 3.5 Micromoles per Liter (umol/L) | Standard Deviation 9.65 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 3 | -1.2 Micromoles per Liter (umol/L) | Standard Deviation 4.04 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 4 | -0.1 Micromoles per Liter (umol/L) | Standard Deviation 0.51 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Follow-up | 4.3 Micromoles per Liter (umol/L) | Standard Deviation 8.65 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 1 | -0.1 Micromoles per Liter (umol/L) | Standard Deviation 0.47 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 5 | 0.1 Micromoles per Liter (umol/L) | Standard Deviation 0.7 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Month 5 | -0.5 Micromoles per Liter (umol/L) | Standard Deviation 5.16 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Follow-up | -1.1 Micromoles per Liter (umol/L) | Standard Deviation 2.43 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Follow-up | 0.3 Micromoles per Liter (umol/L) | Standard Deviation 2.97 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 1 | -0.2 Micromoles per Liter (umol/L) | Standard Deviation 0.58 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 2 | 0.0 Micromoles per Liter (umol/L) | Standard Deviation 0.91 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 3 | -0.5 Micromoles per Liter (umol/L) | Standard Deviation 0.9 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 4 | -0.1 Micromoles per Liter (umol/L) | Standard Deviation 0.99 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 5 | -0.1 Micromoles per Liter (umol/L) | Standard Deviation 0.7 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Follow-up | -0.2 Micromoles per Liter (umol/L) | Standard Deviation 1.17 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 1 | -1.4 Micromoles per Liter (umol/L) | Standard Deviation 2.02 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 2 | 0.2 Micromoles per Liter (umol/L) | Standard Deviation 2.7 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 3 | -0.6 Micromoles per Liter (umol/L) | Standard Deviation 2.5 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 4 | -0.9 Micromoles per Liter (umol/L) | Standard Deviation 1.52 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 5 | -0.5 Micromoles per Liter (umol/L) | Standard Deviation 2.5 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Month 2 | 3.0 Micromoles per Liter (umol/L) | Standard Deviation 9.23 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Month 5 | 2.3 Micromoles per Liter (umol/L) | Standard Deviation 5.44 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Follow-up | 3.5 Micromoles per Liter (umol/L) | Standard Deviation 8.66 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Follow-up | 0.4 Micromoles per Liter (umol/L) | Standard Deviation 0.89 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Month 5 | -6.0 Micromoles per Liter (umol/L) | Standard Deviation 5.2 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 5 | -2.0 Micromoles per Liter (umol/L) | Standard Deviation 2 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 5 | 0.0 Micromoles per Liter (umol/L) | Standard Deviation 0 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 4 | 0.8 Micromoles per Liter (umol/L) | Standard Deviation 1.1 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Follow-up | -0.8 Micromoles per Liter (umol/L) | Standard Deviation 3.35 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 3 | 0.0 Micromoles per Liter (umol/L) | Standard Deviation 0 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 1 | 0.3 Micromoles per Liter (umol/L) | Standard Deviation 0.71 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Month 2 | -5.0 Micromoles per Liter (umol/L) | Standard Deviation 7.07 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 2 | 0.5 Micromoles per Liter (umol/L) | Standard Deviation 3.82 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Direct bilirubin, Month 2 | 0.5 Micromoles per Liter (umol/L) | Standard Deviation 0.93 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 3 | -2.0 Micromoles per Liter (umol/L) | Standard Deviation 1.63 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 1 | 0.4 Micromoles per Liter (umol/L) | Standard Deviation 2.26 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Creatinine, Follow-up | -7.0 Micromoles per Liter (umol/L) | Standard Deviation 14.46 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period | Total bilirubin, Month 4 | -0.4 Micromoles per Liter (umol/L) | Standard Deviation 2.97 |
Change From Baseline (Day 1) in Heart Rate Over Period
Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range \< 50 beats per minute (bpm) or \>110 bpm.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only the participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Follow-up | -0.2 bpm | Standard Deviation 6.78 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 3 | 1.4 bpm | Standard Deviation 10.92 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 1 | -0.6 bpm | Standard Deviation 9.81 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 4 | -2.0 bpm | Standard Deviation 9.8 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 2 | -0.3 bpm | Standard Deviation 8.5 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 5 | -0.8 bpm | Standard Deviation 7.7 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 1 | 2.4 bpm | Standard Deviation 9.19 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 5 | 0.6 bpm | Standard Deviation 10.9 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Follow-up | -1.8 bpm | Standard Deviation 8.07 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 2 | 1.3 bpm | Standard Deviation 8.89 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 3 | -2.5 bpm | Standard Deviation 13.9 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Heart Rate Over Period | Month 4 | 0.7 bpm | Standard Deviation 9.85 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Heart Rate Over Period | Follow-up | 5.0 bpm | Standard Deviation 11.22 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Heart Rate Over Period | Month 1 | 5.1 bpm | Standard Deviation 9.82 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Heart Rate Over Period | Month 3 | 1.3 bpm | Standard Deviation 7.37 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Heart Rate Over Period | Month 4 | -2.2 bpm | Standard Deviation 8.9 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Heart Rate Over Period | Month 5 | 9.3 bpm | Standard Deviation 20.03 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Heart Rate Over Period | Month 2 | 5.0 bpm | Standard Deviation 9.52 |
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only those participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 2 | 0.1 Millimeters of mercury | Standard Deviation 3.46 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month Follow-up | -1.3 Millimeters of mercury | Standard Deviation 3.13 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 1 | 0.2 Millimeters of mercury | Standard Deviation 3.47 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 4 | -0.5 Millimeters of mercury | Standard Deviation 2.35 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 3 | -1.1 Millimeters of mercury | Standard Deviation 4.07 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 5 | -1.1 Millimeters of mercury | Standard Deviation 3.6 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 1 | 0.7 Millimeters of mercury | Standard Deviation 2.23 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 5 | 1.2 Millimeters of mercury | Standard Deviation 2.59 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 2 | 1.2 Millimeters of mercury | Standard Deviation 2.83 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 4 | 1.2 Millimeters of mercury | Standard Deviation 2.71 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month Follow-up | 0.1 Millimeters of mercury | Standard Deviation 2.72 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 3 | 0.7 Millimeters of mercury | Standard Deviation 2.64 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month Follow-up | 0.7 Millimeters of mercury | Standard Deviation 3.5 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 1 | 1.3 Millimeters of mercury | Standard Deviation 2.98 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 2 | 1.1 Millimeters of mercury | Standard Deviation 3.18 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 3 | 2.0 Millimeters of mercury | Standard Deviation 4.69 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 4 | 1.4 Millimeters of mercury | Standard Deviation 5.86 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period | Month 5 | -0.3 Millimeters of mercury | Standard Deviation 5.77 |
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only those participants available at the time of assessment were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Month 5 | 0.0 Femtoliters | Standard Deviation 1.95 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Month 2 | 0.1 Femtoliters | Standard Deviation 2.07 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Follow-up | 0.2 Femtoliters | Standard Deviation 2.1 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Month 5 | -0.6 Femtoliters | Standard Deviation 2.16 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Month 2 | -0.2 Femtoliters | Standard Deviation 1.2 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Follow-up | 0.7 Femtoliters | Standard Deviation 1.2 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Month 2 | -1.1 Femtoliters | Standard Deviation 1.24 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Follow-up | -2.8 Femtoliters | Standard Deviation 0.96 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period | Month 5 | -3.0 Femtoliters | Standard Deviation 0 |
Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period
Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only the participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils, Month 5 | 0.60 Percentage of cells | Standard Deviation 1.564 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Follow-up | -3.16 Percentage of cells | Standard Deviation 9.812 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Month 2 | 0.57 Percentage of cells | Standard Deviation 1.671 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils,Follow-up | 0.64 Percentage of cells | Standard Deviation 2.601 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Month 5 | 0.11 Percentage of cells | Standard Deviation 0.274 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Follow-up | 2.29 Percentage of cells | Standard Deviation 7.79 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Month 5 | 4.42 Percentage of cells | Standard Deviation 9.734 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Month 5 | 1.24 Percentage of cells | Standard Deviation 3.029 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Month 5 | -6.36 Percentage of cells | Standard Deviation 12.291 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Follow-up | 0.17 Percentage of cells | Standard Deviation 0.32 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Month 2 | 0.12 Percentage of cells | Standard Deviation 0.34 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Month 2 | -2.54 Percentage of cells | Standard Deviation 12.125 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils, Month 2 | -0.44 Percentage of cells | Standard Deviation 2.352 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Month 2 | 2.29 Percentage of cells | Standard Deviation 11.781 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Follow-up | 0.06 Percentage of cells | Standard Deviation 1.803 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Follow-up | -0.01 Percentage of cells | Standard Deviation 0.193 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Month 2 | -0.52 Percentage of cells | Standard Deviation 7.788 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Month 2 | 0.12 Percentage of cells | Standard Deviation 0.251 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Month 5 | 0.08 Percentage of cells | Standard Deviation 0.226 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils, Month 2 | 0.19 Percentage of cells | Standard Deviation 1.366 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils, Month 5 | 0.16 Percentage of cells | Standard Deviation 1.879 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils,Follow-up | 0.04 Percentage of cells | Standard Deviation 1.828 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Month 5 | 0.83 Percentage of cells | Standard Deviation 4.759 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Follow-up | -0.62 Percentage of cells | Standard Deviation 4.021 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Month 2 | 0.50 Percentage of cells | Standard Deviation 1.974 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Month 5 | 0.59 Percentage of cells | Standard Deviation 1.358 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Follow-up | -0.32 Percentage of cells | Standard Deviation 1.236 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Month 2 | -0.28 Percentage of cells | Standard Deviation 7.709 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Month 5 | -1.65 Percentage of cells | Standard Deviation 6.02 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Follow-up | 0.90 Percentage of cells | Standard Deviation 5.801 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Month 2 | -0.19 Percentage of cells | Standard Deviation 1.277 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Follow-up | 3.30 Percentage of cells | Standard Deviation 24.091 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Month 5 | -0.67 Percentage of cells | Standard Deviation 0.611 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils, Month 2 | -1.08 Percentage of cells | Standard Deviation 2.089 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Month 5 | -2.70 Percentage of cells | Standard Deviation 7.826 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % monocytes, Follow-up | 0.96 Percentage of cells | Standard Deviation 3.247 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Follow-up | -0.04 Percentage of cells | Standard Deviation 0.182 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Month 2 | -0.96 Percentage of cells | Standard Deviation 4.26 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Month 2 | -0.05 Percentage of cells | Standard Deviation 0.293 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Month 5 | 3.87 Percentage of cells | Standard Deviation 8.051 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils,Follow-up | -0.56 Percentage of cells | Standard Deviation 4.245 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | %Total neutrophils, Month 2 | 2.27 Percentage of cells | Standard Deviation 3.593 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % lymphocytes, Follow-up | -3.66 Percentage of cells | Standard Deviation 17.637 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Eosinophils, Month 5 | -0.30 Percentage of cells | Standard Deviation 0.964 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period | % Basophils, Month 5 | -0.20 Percentage of cells | Standard Deviation 0.173 |
Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period
Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was \<80 or \>140 mm Hg and DBP was \<40 or \>90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population included all participants who received at least one dose of the study drug. Only those participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 4 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 8.49 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 2 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 14.91 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 5 | 8.6 Millimeters of mercury (mmHg) | Standard Deviation 11.83 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 2 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 8.79 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 1 | -2.4 Millimeters of mercury (mmHg) | Standard Deviation 10.55 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Follow-up | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 9.04 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 4 | -4.1 Millimeters of mercury (mmHg) | Standard Deviation 10.37 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 1 | 3.5 Millimeters of mercury (mmHg) | Standard Deviation 9.05 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 5 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 17.16 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 3 | 3.9 Millimeters of mercury (mmHg) | Standard Deviation 8.03 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Follow-up | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 12.65 |
| 5 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 3 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 16.29 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Follow-up | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 9.59 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 5 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 14.71 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 4 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 6.09 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 1 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 8.4 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 2 | 1.6 Millimeters of mercury (mmHg) | Standard Deviation 8.32 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 3 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 8.16 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 5 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 7.4 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 1 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 12.68 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 2 | -3.0 Millimeters of mercury (mmHg) | Standard Deviation 15.37 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 3 | 1.8 Millimeters of mercury (mmHg) | Standard Deviation 12.46 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 4 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 6.98 |
| 2 mg/mL TID | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Follow-up | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 13.44 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 5 | -9.7 Millimeters of mercury (mmHg) | Standard Deviation 1.15 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 2 | -4.0 Millimeters of mercury (mmHg) | Standard Deviation 7.91 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 3 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 7.42 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 1 | 1.1 Millimeters of mercury (mmHg) | Standard Deviation 3.98 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 3 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 10.63 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Follow-up | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 5.99 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 4 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 8.83 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Follow-up | -2.8 Millimeters of mercury (mmHg) | Standard Deviation 11.11 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 5 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 19.73 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 2 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 7.09 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | SBP, Month 1 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 9.22 |
| 5 mg/mL QD | Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period | DBP, Month 4 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 6.12 |
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period
ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only the participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 5 | 0.7 International units per Liter (IU/L) | Standard Deviation 10.82 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 2 | 1.1 International units per Liter (IU/L) | Standard Deviation 7.73 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 3 | 1.2 International units per Liter (IU/L) | Standard Deviation 8.19 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 4 | 2.6 International units per Liter (IU/L) | Standard Deviation 10.58 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 1 | -2.8 International units per Liter (IU/L) | Standard Deviation 8.01 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Follow-up | 3.7 International units per Liter (IU/L) | Standard Deviation 13.77 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 1 | 2.1 International units per Liter (IU/L) | Standard Deviation 3.8 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 2 | 3.0 International units per Liter (IU/L) | Standard Deviation 3.41 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 3 | 0.9 International units per Liter (IU/L) | Standard Deviation 5.54 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 4 | 2.1 International units per Liter (IU/L) | Standard Deviation 5.07 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 5 | 2.3 International units per Liter (IU/L) | Standard Deviation 3.23 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Follow-up | 2.2 International units per Liter (IU/L) | Standard Deviation 4.07 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 1 | 1.7 International units per Liter (IU/L) | Standard Deviation 3.16 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 2 | 2.4 International units per Liter (IU/L) | Standard Deviation 3.42 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 3 | 1.1 International units per Liter (IU/L) | Standard Deviation 3.94 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 4 | 0.1 International units per Liter (IU/L) | Standard Deviation 3.18 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 5 | 1.8 International units per Liter (IU/L) | Standard Deviation 3.16 |
| 5 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Follow-up | 2.0 International units per Liter (IU/L) | Standard Deviation 3.18 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Follow-up | -1.1 International units per Liter (IU/L) | Standard Deviation 3.78 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 1 | -0.6 International units per Liter (IU/L) | Standard Deviation 11.24 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 4 | -1.3 International units per Liter (IU/L) | Standard Deviation 4.55 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 1 | 0.0 International units per Liter (IU/L) | Standard Deviation 3.94 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 2 | 1.8 International units per Liter (IU/L) | Standard Deviation 6.03 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 3 | -1.0 International units per Liter (IU/L) | Standard Deviation 5.56 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 4 | 0.0 International units per Liter (IU/L) | Standard Deviation 3.74 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 3 | 1.3 International units per Liter (IU/L) | Standard Deviation 8.94 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 5 | -2.2 International units per Liter (IU/L) | Standard Deviation 6.82 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 5 | -1.4 International units per Liter (IU/L) | Standard Deviation 5.33 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 4 | -3.5 International units per Liter (IU/L) | Standard Deviation 8.64 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 3 | -0.7 International units per Liter (IU/L) | Standard Deviation 3.39 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 2 | 1.6 International units per Liter (IU/L) | Standard Deviation 3.93 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 5 | -1.6 International units per Liter (IU/L) | Standard Deviation 8.99 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 2 | 2.0 International units per Liter (IU/L) | Standard Deviation 4.12 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Follow-up | -1.1 International units per Liter (IU/L) | Standard Deviation 3.21 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Follow-up | 0.1 International units per Liter (IU/L) | Standard Deviation 7.98 |
| 2 mg/mL TID | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 1 | -0.1 International units per Liter (IU/L) | Standard Deviation 1.9 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Follow-up | 3.6 International units per Liter (IU/L) | Standard Deviation 4.62 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 1 | -0.4 International units per Liter (IU/L) | Standard Deviation 3.93 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 2 | 2.1 International units per Liter (IU/L) | Standard Deviation 4.94 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 3 | 0.0 International units per Liter (IU/L) | Standard Deviation 2.16 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 3 | -0.8 International units per Liter (IU/L) | Standard Deviation 3.59 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Follow-up | 1.2 International units per Liter (IU/L) | Standard Deviation 4.15 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 4 | -0.4 International units per Liter (IU/L) | Standard Deviation 2.3 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Month 5 | -1.0 International units per Liter (IU/L) | Standard Deviation 3 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 4 | 1.2 International units per Liter (IU/L) | Standard Deviation 2.39 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALT, Follow-up | -0.2 International units per Liter (IU/L) | Standard Deviation 2.17 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 1 | -0.1 International units per Liter (IU/L) | Standard Deviation 5.94 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 2 | -2.3 International units per Liter (IU/L) | Standard Deviation 8.31 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 1 | -0.5 International units per Liter (IU/L) | Standard Deviation 3.78 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 3 | -7.5 International units per Liter (IU/L) | Standard Deviation 5.92 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 4 | -1.8 International units per Liter (IU/L) | Standard Deviation 6.91 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | ALP, Month 5 | 8.3 International units per Liter (IU/L) | Standard Deviation 13.8 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 2 | 1.0 International units per Liter (IU/L) | Standard Deviation 2.93 |
| 5 mg/mL QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period | AST, Month 5 | 0.3 International units per Liter (IU/L) | Standard Deviation 2.89 |
Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period
Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up.
Time frame: Baseline (Day 1) and approximately up to 6 months
Population: Safety population. Only those participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Month 5 | 0.11 Millimoles per Liter (mmol/L) | Standard Deviation 0.905 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Follow-up | -0.06 Millimoles per Liter (mmol/L) | Standard Deviation 0.41 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Month 5 | 0.3 Millimoles per Liter (mmol/L) | Standard Deviation 2 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Follow-up | -0.026 Millimoles per Liter (mmol/L) | Standard Deviation 0.0902 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Month 5 | 0.02 Millimoles per Liter (mmol/L) | Standard Deviation 0.544 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Follow-up | -0.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.67 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Month 2 | 0.000 Millimoles per Liter (mmol/L) | Standard Deviation 0.1006 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Month 2 | -0.01 Millimoles per Liter (mmol/L) | Standard Deviation 0.341 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Month 2 | -0.26 Millimoles per Liter (mmol/L) | Standard Deviation 1.087 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Month 2 | -0.09 Millimoles per Liter (mmol/L) | Standard Deviation 1.417 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Follow-up | -0.16 Millimoles per Liter (mmol/L) | Standard Deviation 1.315 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Month 5 | -0.85 Millimoles per Liter (mmol/L) | Standard Deviation 1.167 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Month 2 | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.59 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Month 5 | -0.6 Millimoles per Liter (mmol/L) | Standard Deviation 2.58 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Follow-up | -1.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.77 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Month 5 | -0.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.45 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Month 5 | -0.006 Millimoles per Liter (mmol/L) | Standard Deviation 0.1105 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Follow-up | 0.0 Millimoles per Liter (mmol/L) | Standard Deviation 2.42 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Follow-up | -0.36 Millimoles per Liter (mmol/L) | Standard Deviation 1.509 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Month 2 | 0.0 Millimoles per Liter (mmol/L) | Standard Deviation 1.81 |
| 5 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Month 2 | -0.4 Millimoles per Liter (mmol/L) | Standard Deviation 2.17 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Month 2 | -1.0 Millimoles per Liter (mmol/L) | Standard Deviation 1.87 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Month 5 | -1.1 Millimoles per Liter (mmol/L) | Standard Deviation 0.94 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Month 2 | -0.020 Millimoles per Liter (mmol/L) | Standard Deviation 0.084 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Month 5 | -0.045 Millimoles per Liter (mmol/L) | Standard Deviation 0.0934 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Follow-up | -0.010 Millimoles per Liter (mmol/L) | Standard Deviation 0.0542 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Month 2 | -0.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.99 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Month 5 | 0.5 Millimoles per Liter (mmol/L) | Standard Deviation 1.37 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Follow-up | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 1.7 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Month 2 | -1.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.14 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Month 5 | -1.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.07 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Follow-up | -0.6 Millimoles per Liter (mmol/L) | Standard Deviation 1.86 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Month 2 | 0.46 Millimoles per Liter (mmol/L) | Standard Deviation 1.947 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Month 5 | -0.03 Millimoles per Liter (mmol/L) | Standard Deviation 1.698 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Follow-up | 0.22 Millimoles per Liter (mmol/L) | Standard Deviation 2.561 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Month 2 | -0.02 Millimoles per Liter (mmol/L) | Standard Deviation 0.251 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Month 5 | -0.11 Millimoles per Liter (mmol/L) | Standard Deviation 0.406 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Follow-up | -0.06 Millimoles per Liter (mmol/L) | Standard Deviation 0.277 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Follow-up | -1.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.23 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Month 2 | 0.12 Millimoles per Liter (mmol/L) | Standard Deviation 1.267 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Month 5 | 0.67 Millimoles per Liter (mmol/L) | Standard Deviation 1.034 |
| 2 mg/mL TID | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Follow-up | 0.40 Millimoles per Liter (mmol/L) | Standard Deviation 1.059 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Month 5 | -0.100 Millimoles per Liter (mmol/L) | Standard Deviation 0.0917 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Month 5 | -0.53 Millimoles per Liter (mmol/L) | Standard Deviation 0.404 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Month 2 | -1.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.6 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Follow-up | 1.00 Millimoles per Liter (mmol/L) | Standard Deviation 0.5 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Follow-up | -0.44 Millimoles per Liter (mmol/L) | Standard Deviation 0.114 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Follow-up | -0.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.59 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Month 2 | -0.050 Millimoles per Liter (mmol/L) | Standard Deviation 0.1189 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Month 2 | 0.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.25 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Month 5 | -2.7 Millimoles per Liter (mmol/L) | Standard Deviation 1.53 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Month 2 | 0.5 Millimoles per Liter (mmol/L) | Standard Deviation 1.77 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Month 5 | -0.17 Millimoles per Liter (mmol/L) | Standard Deviation 0.764 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Sodium, Follow-up | -0.6 Millimoles per Liter (mmol/L) | Standard Deviation 0.55 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Calcium, Follow-up | -0.028 Millimoles per Liter (mmol/L) | Standard Deviation 0.1221 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Month 5 | 1.70 Millimoles per Liter (mmol/L) | Standard Deviation 3.329 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Month 2 | 0.95 Millimoles per Liter (mmol/L) | Standard Deviation 1.622 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Chloride, Month 5 | -2.0 Millimoles per Liter (mmol/L) | Standard Deviation 1.73 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Glucose, Follow-up | 0.34 Millimoles per Liter (mmol/L) | Standard Deviation 1.354 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Follow-up | -0.6 Millimoles per Liter (mmol/L) | Standard Deviation 3.91 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Urea/BUN, Month 2 | 0.06 Millimoles per Liter (mmol/L) | Standard Deviation 1.13 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | Potassium, Month 2 | -0.20 Millimoles per Liter (mmol/L) | Standard Deviation 0.385 |
| 5 mg/mL QD | Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period | CO2, Month 5 | -1.0 Millimoles per Liter (mmol/L) | Standard Deviation 5.29 |
Number of Participants With Abnormal Anterior Chamber Examination of PCI
A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination.
Time frame: Approximately up to 6 months
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Anterior Chamber Examination of PCI | 0 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Anterior Chamber Examination of PCI | 0 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Anterior Chamber Examination of PCI | 0 Participants |
Number of Participants With Abnormal Conjunctival Examination of PCI
A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months).
Time frame: Up to follow-up (approximately 6 months)
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Conjunctival Examination of PCI | 0 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Conjunctival Examination of PCI | 0 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Conjunctival Examination of PCI | 0 Participants |
Number of Participants With Abnormal Corneal Examination of PCI
A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (\<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period).
Time frame: Approximately up to 6 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Corneal Examination of PCI | 2 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Corneal Examination of PCI | 0 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Corneal Examination of PCI | 0 Participants |
Number of Participants With Abnormal (Dilated) Fundus Examination
Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA.
Time frame: Approximately up to 6 months
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal (Dilated) Fundus Examination | 4 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal (Dilated) Fundus Examination | 1 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal (Dilated) Fundus Examination | 2 Participants |
Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale
A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma.
Time frame: Approximately up to 6 months
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale | 0 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale | 1 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale | 1 Participants |
Number of Participants With Abnormal Pupil Examination of PCI
Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined.
Time frame: Up to follow-up (approximately 6 months)
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Pupil Examination of PCI | 2 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Pupil Examination of PCI | 1 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Pupil Examination of PCI | 1 Participants |
Number of Participants With Abnormal Tear Films of PCI
Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes.
Time frame: Approximately up to 6 months
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Tear Films of PCI | 3 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Tear Films of PCI | 1 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Tear Films of PCI | 1 Participants |
Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)
Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented.
Time frame: Approximately up to 6 months
Population: Safety population. Only those participants available at the time of assessment were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI) | 2 Participants |
| 2 mg/mL TID | Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI) | 2 Participants |
| 5 mg/mL QD | Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI) | 0 Participants |
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
Time frame: Approximately up to 6 months
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any AE, non-ocular | 11 Participants |
| 5 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any SAE, non-ocular | 2 Participants |
| 5 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any AE, ocular | 8 Participants |
| 5 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any SAE, ocular | 0 Participants |
| 2 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any SAE, ocular | 1 Participants |
| 2 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any AE, non-ocular | 9 Participants |
| 2 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any AE, ocular | 3 Participants |
| 2 mg/mL TID | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any SAE, non-ocular | 0 Participants |
| 5 mg/mL QD | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any SAE, ocular | 0 Participants |
| 5 mg/mL QD | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any SAE, non-ocular | 0 Participants |
| 5 mg/mL QD | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any AE, ocular | 2 Participants |
| 5 mg/mL QD | Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) | Any AE, non-ocular | 3 Participants |
Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function
Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI.
Time frame: Approximately up to 6 months
Population: Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg/mL TID | Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function | 1 Participants |
| 2 mg/mL TID | Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function | 0 Participants |
| 5 mg/mL QD | Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function | 1 Participants |
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive).
Time frame: Approximately up to 6 months (up to follow-up)
Population: Safety population. Only those participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Follow-up, traces | 1 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Follow-up, traces | 3 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine ketones, Follow-up, traces | 1 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine glucose, Month 5, traces | 0 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine ketones, Month 2, traces | 1 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine glucose, Follow-up, 1+ OR 1/4/G/DL (5%) | 0 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 5, 1+ | 0 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 2, traces | 3 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Follow-up, 1+ | 0 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 2, traces | 3 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 5, traces | 0 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 2, 1+ | 0 Participants |
| 5 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 2, 1+ | 0 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine glucose, Month 5, traces | 1 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 5, 1+ | 1 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 2, 1+ | 0 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 2, traces | 2 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 5, traces | 2 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Follow-up, traces | 0 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine glucose, Follow-up, 1+ OR 1/4/G/DL (5%) | 1 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine ketones, Month 2, traces | 0 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine ketones, Follow-up, traces | 1 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 2, 1+ | 0 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 2, traces | 0 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Follow-up, 1+ | 1 Participants |
| 2 mg/mL TID | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Follow-up, traces | 2 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 5, traces | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Follow-up, traces | 1 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 2, 1+ | 1 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 2, traces | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine ketones, Month 2, traces | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 2, traces | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Month 2, 1+ | 1 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine glucose, Follow-up, 1+ OR 1/4/G/DL (5%) | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine glucose, Month 5, traces | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Month 5, 1+ | 1 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine blood occult, Follow-up, traces | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine protein, Follow-up, 1+ | 0 Participants |
| 5 mg/mL QD | Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis | Urine ketones, Follow-up, traces | 0 Participants |
Change From Baseline (Screening Visit) in BCVA at Month 2 and 5
Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.
Time frame: From Baseline (screening visit), Month 2, and Month 5
Population: Efficacy population included all participants in safety population who have classic choroidal neovascularization present as detected by fluorescein angiography in the previous screening visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | IVT Treatment naive, Month 5 | -5.6 Number of letters | Standard Deviation 12.6 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | IVT Treatment naive, Month 2 | 0.1 Number of letters | Standard Deviation 4.85 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | Previously treated with IVT, Month 2 | -1.6 Number of letters | Standard Deviation 4.28 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | Previously treated with IVT, Month 5 | -1.3 Number of letters | Standard Deviation 3.3 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | Previously treated with IVT, Month 5 | -2.0 Number of letters | Standard Deviation 7.21 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | IVT Treatment naive, Month 2 | -5.3 Number of letters | Standard Deviation 6.24 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | IVT Treatment naive, Month 5 | -5.3 Number of letters | Standard Deviation 6.7 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | Previously treated with IVT, Month 2 | -3.5 Number of letters | Standard Deviation 4.65 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | IVT Treatment naive, Month 2 | -0.7 Number of letters | Standard Deviation 3.06 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 | IVT Treatment naive, Month 5 | -3.0 Number of letters | — |
Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months
The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.
Time frame: From Baseline (Screening visit) and up to 5 months
Population: Pharmacodynamic subpopulation included participants that were analyzed for PD outcome measures. Only the participants available at the time of assessment were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 1 | 8.3 Microns | Standard Deviation 48.19 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 4 | -86.8 Microns | Standard Deviation 151.02 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 4 | -19.2 Microns | Standard Deviation 52.77 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 2 | 16.3 Microns | Standard Deviation 62.32 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 3 | -66.2 Microns | Standard Deviation 126.35 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 2 | -99.0 Microns | Standard Deviation 180.74 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 1 | 46.4 Microns | Standard Deviation 130.3 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 5 | -15.6 Microns | Standard Deviation 52.13 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 5 | -55.5 Microns | Standard Deviation 159.53 |
| 5 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 3 | -31.3 Microns | Standard Deviation 43.43 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 5 | 3.0 Microns | Standard Deviation 66.43 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 5 | 7.3 Microns | Standard Deviation 45.11 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 2 | -10.0 Microns | Standard Deviation 108.19 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 1 | 41.1 Microns | Standard Deviation 99.51 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 2 | 18.3 Microns | Standard Deviation 45.09 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 3 | 31.3 Microns | Standard Deviation 61.36 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 4 | -15.3 Microns | Standard Deviation 41.28 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 1 | -1.3 Microns | Standard Deviation 27.93 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 3 | 2.0 Microns | Standard Deviation 37.99 |
| 2 mg/mL TID | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 4 | 0.3 Microns | Standard Deviation 87.37 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 4 | -168.5 Microns | Standard Deviation 246.78 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 2 | 3.0 Microns | Standard Deviation 47.32 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 3 | 12.0 Microns | Standard Deviation 5.66 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 1 | -18.0 Microns | Standard Deviation 37.4 |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Previously treated, Month 1 | 36.0 Microns | — |
| 5 mg/mL QD | Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months | Treatment naive, Month 5 | 16.0 Microns | — |
Change in Neo-vascular Size and Lesion Size Over Period
The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure.
Time frame: Up to 6 weeks
Population: PD population was planned for analysis of this outcome; however, Data was not collected for this outcome measure.
Number of Participants With Lesion Types Over Period
Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.
Time frame: Up to 6 months
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5 mg/mL TID | Number of Participants With Lesion Types Over Period | Occult | 16 Participants |
| 5 mg/mL TID | Number of Participants With Lesion Types Over Period | Minimally classic | 2 Participants |
| 2 mg/mL TID | Number of Participants With Lesion Types Over Period | Occult | 11 Participants |
| 2 mg/mL TID | Number of Participants With Lesion Types Over Period | Minimally classic | 4 Participants |
| 5 mg/mL QD | Number of Participants With Lesion Types Over Period | Occult | 3 Participants |
| 5 mg/mL QD | Number of Participants With Lesion Types Over Period | Minimally classic | 5 Participants |