Trial Outcomes & Findings for An Extension to Study MD7108240 (NCT NCT00733304)
NCT ID: NCT00733304
Last Updated: 2017-12-05
Results Overview
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.
COMPLETED
PHASE2
42 participants
Baseline (Day 1) and approximately up to 6 months
2017-12-05
Participant Flow
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.
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.
Participant milestones
| Measure |
5 mg/mL TID
Eligible participants received 5 milligram/milliliter (mg/mL) Pazopanib eye drops three times daily for a treatment period of five months.
|
2 mg/mL TID
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
5 mg/mL QD
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
8
|
|
Overall Study
COMPLETED
|
12
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
5
|
Reasons for withdrawal
| Measure |
5 mg/mL TID
Eligible participants received 5 milligram/milliliter (mg/mL) Pazopanib eye drops three times daily for a treatment period of five months.
|
2 mg/mL TID
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
5 mg/mL QD
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
|
|---|---|---|---|
|
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
Safety Population
Baseline characteristics by cohort
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
55 to 88 aged
|
19 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants • Safety Population
|
7 Participants
n=4 Participants • Safety Population
|
5 Participants
n=27 Participants • Safety Population
|
27 Participants
n=483 Participants • Safety Population
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants • Safety Population
|
8 Participants
n=4 Participants • Safety Population
|
3 Participants
n=27 Participants • Safety Population
|
15 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • Safety Population
|
0 Participants
n=4 Participants • Safety Population
|
0 Participants
n=27 Participants • Safety Population
|
0 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants • Safety Population
|
0 Participants
n=4 Participants • Safety Population
|
0 Participants
n=27 Participants • Safety Population
|
0 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • Safety Population
|
0 Participants
n=4 Participants • Safety Population
|
0 Participants
n=27 Participants • Safety Population
|
0 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants • Safety Population
|
0 Participants
n=4 Participants • Safety Population
|
0 Participants
n=27 Participants • Safety Population
|
0 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants • Safety Population
|
15 Participants
n=4 Participants • Safety Population
|
8 Participants
n=27 Participants • Safety Population
|
42 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants • Safety Population
|
0 Participants
n=4 Participants • Safety Population
|
0 Participants
n=27 Participants • Safety Population
|
0 Participants
n=483 Participants • Safety Population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • Safety Population
|
0 Participants
n=4 Participants • Safety Population
|
0 Participants
n=27 Participants • Safety Population
|
0 Participants
n=483 Participants • Safety Population
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 8.40
|
1.1 Millimeters of mercury (mmHg)
Standard Deviation 3.98
|
|
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
|
1.6 Millimeters of mercury (mmHg)
Standard Deviation 8.32
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 7.09
|
|
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
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 8.16
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 7.42
|
|
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
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 6.09
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 6.12
|
|
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
|
1.8 Millimeters of mercury (mmHg)
Standard Deviation 7.40
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 19.73
|
|
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
|
1.8 Millimeters of mercury (mmHg)
Standard Deviation 9.59
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 11.11
|
|
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
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 12.68
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 9.22
|
|
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
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation 15.37
|
-4.0 Millimeters of mercury (mmHg)
Standard Deviation 7.91
|
|
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
|
1.8 Millimeters of mercury (mmHg)
Standard Deviation 12.46
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 10.63
|
|
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
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 6.98
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 8.83
|
|
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
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 14.71
|
-9.7 Millimeters of mercury (mmHg)
Standard Deviation 1.15
|
|
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
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 13.44
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 5.99
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only the participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Change From Baseline (Day 1) in Heart Rate Over Period
Month 1
|
-0.6 bpm
Standard Deviation 9.81
|
2.4 bpm
Standard Deviation 9.19
|
5.1 bpm
Standard Deviation 9.82
|
|
Change From Baseline (Day 1) in Heart Rate Over Period
Month 2
|
-0.3 bpm
Standard Deviation 8.50
|
1.3 bpm
Standard Deviation 8.89
|
5.0 bpm
Standard Deviation 9.52
|
|
Change From Baseline (Day 1) in Heart Rate Over Period
Month 3
|
1.4 bpm
Standard Deviation 10.92
|
-2.5 bpm
Standard Deviation 13.90
|
1.3 bpm
Standard Deviation 7.37
|
|
Change From Baseline (Day 1) in Heart Rate Over Period
Month 4
|
-2.0 bpm
Standard Deviation 9.80
|
0.7 bpm
Standard Deviation 9.85
|
-2.2 bpm
Standard Deviation 8.90
|
|
Change From Baseline (Day 1) in Heart Rate Over Period
Month 5
|
-0.8 bpm
Standard Deviation 7.70
|
0.6 bpm
Standard Deviation 10.90
|
9.3 bpm
Standard Deviation 20.03
|
|
Change From Baseline (Day 1) in Heart Rate Over Period
Follow-up
|
-0.2 bpm
Standard Deviation 6.78
|
-1.8 bpm
Standard Deviation 8.07
|
5.0 bpm
Standard Deviation 11.22
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Month 2, 5 and approximately up to Month 6Population: Safety population. Only the participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Albumin, Month 2
|
0.6 Grams per liter
Standard Deviation 1.46
|
-0.7 Grams per liter
Standard Deviation 1.38
|
-1.1 Grams per liter
Standard Deviation 1.96
|
|
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Albumin, Month 5
|
0.3 Grams per liter
Standard Deviation 2.15
|
-1.0 Grams per liter
Standard Deviation 1.34
|
-3.0 Grams per liter
Standard Deviation 1.00
|
|
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Albumin, Follow-up
|
-0.4 Grams per liter
Standard Deviation 1.67
|
-1.1 Grams per liter
Standard Deviation 1.45
|
0.2 Grams per liter
Standard Deviation 1.30
|
|
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Hemoglobin, Month 2
|
2.1 Grams per liter
Standard Deviation 6.95
|
-0.5 Grams per liter
Standard Deviation 4.22
|
-1.3 Grams per liter
Standard Deviation 8.35
|
|
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Hemoglobin, Month 5
|
-0.2 Grams per liter
Standard Deviation 10.04
|
0.3 Grams per liter
Standard Deviation 5.05
|
-6.0 Grams per liter
Standard Deviation 0.00
|
|
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Hemoglobin, Follow-up
|
-0.2 Grams per liter
Standard Deviation 8.65
|
0.4 Grams per liter
Standard Deviation 8.66
|
2.5 Grams per liter
Standard Deviation 5.26
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only the participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
-0.6 International units per Liter (IU/L)
Standard Deviation 11.24
|
-0.1 International units per Liter (IU/L)
Standard Deviation 5.94
|
|
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
|
1.8 International units per Liter (IU/L)
Standard Deviation 6.03
|
-2.3 International units per Liter (IU/L)
Standard Deviation 8.31
|
|
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
|
1.3 International units per Liter (IU/L)
Standard Deviation 8.94
|
-7.5 International units per Liter (IU/L)
Standard Deviation 5.92
|
|
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
|
-3.5 International units per Liter (IU/L)
Standard Deviation 8.64
|
-1.8 International units per Liter (IU/L)
Standard Deviation 6.91
|
|
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
|
-1.6 International units per Liter (IU/L)
Standard Deviation 8.99
|
8.3 International units per Liter (IU/L)
Standard Deviation 13.80
|
|
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
|
0.1 International units per Liter (IU/L)
Standard Deviation 7.98
|
3.6 International units per Liter (IU/L)
Standard Deviation 4.62
|
|
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 3.80
|
-0.1 International units per Liter (IU/L)
Standard Deviation 1.90
|
-0.4 International units per Liter (IU/L)
Standard Deviation 3.93
|
|
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
|
2.0 International units per Liter (IU/L)
Standard Deviation 4.12
|
2.1 International units per Liter (IU/L)
Standard Deviation 4.94
|
|
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
|
-0.7 International units per Liter (IU/L)
Standard Deviation 3.39
|
-0.8 International units per Liter (IU/L)
Standard Deviation 3.59
|
|
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
|
-1.3 International units per Liter (IU/L)
Standard Deviation 4.55
|
-0.4 International units per Liter (IU/L)
Standard Deviation 2.30
|
|
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
|
-2.2 International units per Liter (IU/L)
Standard Deviation 6.82
|
-1.0 International units per Liter (IU/L)
Standard Deviation 3.00
|
|
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
|
-1.1 International units per Liter (IU/L)
Standard Deviation 3.21
|
-0.2 International units per Liter (IU/L)
Standard Deviation 2.17
|
|
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
|
0.0 International units per Liter (IU/L)
Standard Deviation 3.94
|
-0.5 International units per Liter (IU/L)
Standard Deviation 3.78
|
|
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
|
1.6 International units per Liter (IU/L)
Standard Deviation 3.93
|
1.0 International units per Liter (IU/L)
Standard Deviation 2.93
|
|
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
|
-1.0 International units per Liter (IU/L)
Standard Deviation 5.56
|
0.0 International units per Liter (IU/L)
Standard Deviation 2.16
|
|
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
|
0.0 International units per Liter (IU/L)
Standard Deviation 3.74
|
1.2 International units per Liter (IU/L)
Standard Deviation 2.39
|
|
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
|
-1.4 International units per Liter (IU/L)
Standard Deviation 5.33
|
0.3 International units per Liter (IU/L)
Standard Deviation 2.89
|
|
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
|
-1.1 International units per Liter (IU/L)
Standard Deviation 3.78
|
1.2 International units per Liter (IU/L)
Standard Deviation 4.15
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only the participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
-0.003 Giga per Liter (G/L)
Standard Deviation 0.0142
|
0.00 Giga per Liter (G/L)
Standard Deviation 0.00
|
|
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
|
0.008 Giga per Liter (G/L)
Standard Deviation 0.0157
|
-0.003 Giga per Liter (G/L)
Standard Deviation 0.0271
|
|
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
|
0.006 Giga per Liter (G/L)
Standard Deviation 0.0168
|
-0.010 Giga per Liter (G/L)
Standard Deviation 0.0141
|
|
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
|
0.010 Giga per Liter (G/L)
Standard Deviation 0.1204
|
-0.088 Giga per Liter (G/L)
Standard Deviation 0.1784
|
|
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
|
-0.009 Giga per Liter (G/L)
Standard Deviation 0.1324
|
0.030 Giga per Liter (G/L)
Standard Deviation 0.1131
|
|
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
|
0.007 Giga per Liter (G/L)
Standard Deviation 0.1083
|
0.032 Giga per Liter (G/L)
Standard Deviation 0.0613
|
|
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
|
0.051 Giga per Liter (G/L)
Standard Deviation 0.4203
|
-0.031 Giga per Liter (G/L)
Standard Deviation 0.3855
|
|
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
|
0.068 Giga per Liter (G/L)
Standard Deviation 0.2245
|
0.130 Giga per Liter (G/L)
Standard Deviation 0.3536
|
|
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
|
0.090 Giga per Liter (G/L)
Standard Deviation 0.3412
|
0.062 Giga per Liter (G/L)
Standard Deviation 0.1959
|
|
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
|
0.025 Giga per Liter (G/L)
Standard Deviation 0.1621
|
0.020 Giga per Liter (G/L)
Standard Deviation 0.1812
|
|
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
|
0.036 Giga per Liter (G/L)
Standard Deviation 0.1272
|
-0.015 Giga per Liter (G/L)
Standard Deviation 0.1202
|
|
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
|
0.002 Giga per Liter (G/L)
Standard Deviation 0.1293
|
0.030 Giga per Liter (G/L)
Standard Deviation 0.0942
|
|
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
|
1.3 Giga per Liter (G/L)
Standard Deviation 21.39
|
11.9 Giga per Liter (G/L)
Standard Deviation 29.30
|
|
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
|
-10.9 Giga per Liter (G/L)
Standard Deviation 15.48
|
70.0 Giga per Liter (G/L)
Standard Deviation 62.23
|
|
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 22.50
|
-7.3 Giga per Liter (G/L)
Standard Deviation 19.31
|
8.3 Giga per Liter (G/L)
Standard Deviation 7.50
|
|
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
|
-0.02 Giga per Liter (G/L)
Standard Deviation 1.027
|
0.26 Giga per Liter (G/L)
Standard Deviation 1.334
|
|
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
|
-0.00 Giga per Liter (G/L)
Standard Deviation 1.484
|
0.50 Giga per Liter (G/L)
Standard Deviation 1.697
|
|
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
|
0.76 Giga per Liter (G/L)
Standard Deviation 2.558
|
-0.07 Giga per Liter (G/L)
Standard Deviation 2.251
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only the participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
0.59 Percentage of cells
Standard Deviation 1.358
|
-0.67 Percentage of cells
Standard Deviation 0.611
|
|
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
|
-0.32 Percentage of cells
Standard Deviation 1.236
|
0.96 Percentage of cells
Standard Deviation 3.247
|
|
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
|
-0.28 Percentage of cells
Standard Deviation 7.709
|
2.27 Percentage of cells
Standard Deviation 3.593
|
|
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
|
0.90 Percentage of cells
Standard Deviation 5.801
|
3.30 Percentage of cells
Standard Deviation 24.091
|
|
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
|
-1.65 Percentage of cells
Standard Deviation 6.020
|
-2.70 Percentage of cells
Standard Deviation 7.826
|
|
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 0.340
|
0.12 Percentage of cells
Standard Deviation 0.251
|
-0.05 Percentage of cells
Standard Deviation 0.293
|
|
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
|
0.08 Percentage of cells
Standard Deviation 0.226
|
-0.20 Percentage of cells
Standard Deviation 0.173
|
|
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 0.320
|
-0.01 Percentage of cells
Standard Deviation 0.193
|
-0.04 Percentage of cells
Standard Deviation 0.182
|
|
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
|
0.19 Percentage of cells
Standard Deviation 1.366
|
-1.08 Percentage of cells
Standard Deviation 2.089
|
|
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
|
0.16 Percentage of cells
Standard Deviation 1.879
|
-0.30 Percentage of cells
Standard Deviation 0.964
|
|
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
|
0.04 Percentage of cells
Standard Deviation 1.828
|
-0.56 Percentage of cells
Standard Deviation 4.245
|
|
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
|
-0.52 Percentage of cells
Standard Deviation 7.788
|
-0.96 Percentage of cells
Standard Deviation 4.260
|
|
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
|
0.83 Percentage of cells
Standard Deviation 4.759
|
3.87 Percentage of cells
Standard Deviation 8.051
|
|
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 7.790
|
-0.62 Percentage of cells
Standard Deviation 4.021
|
-3.66 Percentage of cells
Standard Deviation 17.637
|
|
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
|
0.50 Percentage of cells
Standard Deviation 1.974
|
-0.19 Percentage of cells
Standard Deviation 1.277
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only those participants available at the time of assessment were analyzed.
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
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
0.3 Micromoles per Liter (umol/L)
Standard Deviation 2.97
|
-0.8 Micromoles per Liter (umol/L)
Standard Deviation 3.35
|
|
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
|
-0.2 Micromoles per Liter (umol/L)
Standard Deviation 0.58
|
0.3 Micromoles per Liter (umol/L)
Standard Deviation 0.71
|
|
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
|
0.0 Micromoles per Liter (umol/L)
Standard Deviation 0.91
|
0.5 Micromoles per Liter (umol/L)
Standard Deviation 0.93
|
|
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
|
-0.5 Micromoles per Liter (umol/L)
Standard Deviation 0.90
|
0.0 Micromoles per Liter (umol/L)
Standard Deviation 0.0
|
|
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
|
-0.1 Micromoles per Liter (umol/L)
Standard Deviation 0.99
|
0.8 Micromoles per Liter (umol/L)
Standard Deviation 1.10
|
|
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 0.70
|
-0.1 Micromoles per Liter (umol/L)
Standard Deviation 0.70
|
0.0 Micromoles per Liter (umol/L)
Standard Deviation 0.0
|
|
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 1.00
|
-0.2 Micromoles per Liter (umol/L)
Standard Deviation 1.17
|
0.4 Micromoles per Liter (umol/L)
Standard Deviation 0.89
|
|
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
|
-1.4 Micromoles per Liter (umol/L)
Standard Deviation 2.02
|
0.4 Micromoles per Liter (umol/L)
Standard Deviation 2.26
|
|
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
|
0.2 Micromoles per Liter (umol/L)
Standard Deviation 2.70
|
0.5 Micromoles per Liter (umol/L)
Standard Deviation 3.82
|
|
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
|
-0.6 Micromoles per Liter (umol/L)
Standard Deviation 2.50
|
-2.0 Micromoles per Liter (umol/L)
Standard Deviation 1.63
|
|
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
|
-0.9 Micromoles per Liter (umol/L)
Standard Deviation 1.52
|
-0.4 Micromoles per Liter (umol/L)
Standard Deviation 2.97
|
|
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
|
-0.5 Micromoles per Liter (umol/L)
Standard Deviation 2.50
|
-2.0 Micromoles per Liter (umol/L)
Standard Deviation 2.00
|
|
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
|
3.0 Micromoles per Liter (umol/L)
Standard Deviation 9.23
|
-5.0 Micromoles per Liter (umol/L)
Standard Deviation 7.07
|
|
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
|
2.3 Micromoles per Liter (umol/L)
Standard Deviation 5.44
|
-6.0 Micromoles per Liter (umol/L)
Standard Deviation 5.20
|
|
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
|
3.5 Micromoles per Liter (umol/L)
Standard Deviation 8.66
|
-7.0 Micromoles per Liter (umol/L)
Standard Deviation 14.46
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only those participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
-0.020 Millimoles per Liter (mmol/L)
Standard Deviation 0.0840
|
-0.050 Millimoles per Liter (mmol/L)
Standard Deviation 0.1189
|
|
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
|
-0.045 Millimoles per Liter (mmol/L)
Standard Deviation 0.0934
|
-0.100 Millimoles per Liter (mmol/L)
Standard Deviation 0.0917
|
|
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
|
-0.010 Millimoles per Liter (mmol/L)
Standard Deviation 0.0542
|
-0.028 Millimoles per Liter (mmol/L)
Standard Deviation 0.1221
|
|
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
|
-0.2 Millimoles per Liter (mmol/L)
Standard Deviation 1.99
|
0.5 Millimoles per Liter (mmol/L)
Standard Deviation 1.77
|
|
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
|
0.5 Millimoles per Liter (mmol/L)
Standard Deviation 1.37
|
-2.0 Millimoles per Liter (mmol/L)
Standard Deviation 1.73
|
|
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
|
0.1 Millimoles per Liter (mmol/L)
Standard Deviation 1.70
|
-0.2 Millimoles per Liter (mmol/L)
Standard Deviation 2.59
|
|
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
|
-1.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.14
|
-1.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.60
|
|
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 2.00
|
-1.1 Millimoles per Liter (mmol/L)
Standard Deviation 2.07
|
-1.0 Millimoles per Liter (mmol/L)
Standard Deviation 5.29
|
|
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
|
-0.6 Millimoles per Liter (mmol/L)
Standard Deviation 1.86
|
-0.6 Millimoles per Liter (mmol/L)
Standard Deviation 3.91
|
|
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
|
0.46 Millimoles per Liter (mmol/L)
Standard Deviation 1.947
|
0.95 Millimoles per Liter (mmol/L)
Standard Deviation 1.622
|
|
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
|
-0.03 Millimoles per Liter (mmol/L)
Standard Deviation 1.698
|
1.70 Millimoles per Liter (mmol/L)
Standard Deviation 3.329
|
|
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
|
0.22 Millimoles per Liter (mmol/L)
Standard Deviation 2.561
|
0.34 Millimoles per Liter (mmol/L)
Standard Deviation 1.354
|
|
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
|
-0.02 Millimoles per Liter (mmol/L)
Standard Deviation 0.251
|
-0.20 Millimoles per Liter (mmol/L)
Standard Deviation 0.385
|
|
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
|
-0.11 Millimoles per Liter (mmol/L)
Standard Deviation 0.406
|
-0.53 Millimoles per Liter (mmol/L)
Standard Deviation 0.404
|
|
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 0.410
|
-0.06 Millimoles per Liter (mmol/L)
Standard Deviation 0.277
|
-0.44 Millimoles per Liter (mmol/L)
Standard Deviation 0.114
|
|
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
|
-1.0 Millimoles per Liter (mmol/L)
Standard Deviation 1.87
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.25
|
|
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
|
-1.1 Millimoles per Liter (mmol/L)
Standard Deviation 0.94
|
-2.7 Millimoles per Liter (mmol/L)
Standard Deviation 1.53
|
|
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
|
-1.2 Millimoles per Liter (mmol/L)
Standard Deviation 2.23
|
-0.6 Millimoles per Liter (mmol/L)
Standard Deviation 0.55
|
|
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
|
0.12 Millimoles per Liter (mmol/L)
Standard Deviation 1.267
|
0.06 Millimoles per Liter (mmol/L)
Standard Deviation 1.130
|
|
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
|
0.67 Millimoles per Liter (mmol/L)
Standard Deviation 1.034
|
-0.17 Millimoles per Liter (mmol/L)
Standard Deviation 0.764
|
|
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
|
0.40 Millimoles per Liter (mmol/L)
Standard Deviation 1.059
|
1.00 Millimoles per Liter (mmol/L)
Standard Deviation 0.500
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only those participants available at the time of assessment were analyzed
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Month 2
|
0.1 Femtoliters
Standard Deviation 2.07
|
-0.2 Femtoliters
Standard Deviation 1.20
|
-1.1 Femtoliters
Standard Deviation 1.24
|
|
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Month 5
|
0.0 Femtoliters
Standard Deviation 1.95
|
-0.6 Femtoliters
Standard Deviation 2.16
|
-3.0 Femtoliters
Standard Deviation 0.00
|
|
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Follow-up
|
0.2 Femtoliters
Standard Deviation 2.10
|
0.7 Femtoliters
Standard Deviation 1.20
|
-2.8 Femtoliters
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and approximately up to 6 monthsPopulation: Safety population. Only those participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Month 1
|
0.2 Millimeters of mercury
Standard Deviation 3.47
|
0.7 Millimeters of mercury
Standard Deviation 2.23
|
1.3 Millimeters of mercury
Standard Deviation 2.98
|
|
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Month 2
|
0.1 Millimeters of mercury
Standard Deviation 3.46
|
1.2 Millimeters of mercury
Standard Deviation 2.83
|
1.1 Millimeters of mercury
Standard Deviation 3.18
|
|
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Month 3
|
-1.1 Millimeters of mercury
Standard Deviation 4.07
|
0.7 Millimeters of mercury
Standard Deviation 2.64
|
2.0 Millimeters of mercury
Standard Deviation 4.69
|
|
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Month 4
|
-0.5 Millimeters of mercury
Standard Deviation 2.35
|
1.2 Millimeters of mercury
Standard Deviation 2.71
|
1.4 Millimeters of mercury
Standard Deviation 5.86
|
|
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Month 5
|
-1.1 Millimeters of mercury
Standard Deviation 3.60
|
1.2 Millimeters of mercury
Standard Deviation 2.59
|
-0.3 Millimeters of mercury
Standard Deviation 5.77
|
|
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Month Follow-up
|
-1.3 Millimeters of mercury
Standard Deviation 3.13
|
0.1 Millimeters of mercury
Standard Deviation 2.72
|
0.7 Millimeters of mercury
Standard Deviation 3.50
|
PRIMARY outcome
Timeframe: Approximately up to 6 months (up to follow-up)Population: Safety population. Only those participants available at the time of assessment were analyzed.
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).
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
0 Participants
|
1 Participants
|
|
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
|
2 Participants
|
0 Participants
|
|
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
|
2 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine glucose, Month 5, traces
|
0 Participants
|
1 Participants
|
0 Participants
|
|
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
|
1 Participants
|
0 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine ketones, Month 2, traces
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine ketones, Follow-up, traces
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine protein, Month 2, 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine protein, Month 2, traces
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine protein, Month 5, 1+
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine protein, Follow-up, 1+
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Urine protein, Follow-up, traces
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Any SAE, ocular
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Any AE, non-ocular
|
11 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Any SAE, non-ocular
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Any AE, ocular
|
8 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population. Only those participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to follow-up (approximately 6 months)Population: Safety population.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Pupil Examination of PCI
|
2 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to follow-up (approximately 6 months)Population: Safety population.
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).
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Conjunctival Examination of PCI
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Anterior Chamber Examination of PCI
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population
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).
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Corneal Examination of PCI
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal Tear Films of PCI
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 6 monthsPopulation: Safety population.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Abnormal (Dilated) Fundus Examination
|
4 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline (screening visit), Month 2, and Month 5Population: Efficacy population included all participants in safety population who have classic choroidal neovascularization present as detected by fluorescein angiography in the previous screening visit.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=13 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=12 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=4 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
-5.3 Number of letters
Standard Deviation 6.24
|
-0.7 Number of letters
Standard Deviation 3.06
|
|
Change From Baseline (Screening Visit) in BCVA at Month 2 and 5
IVT Treatment naive, Month 5
|
-5.6 Number of letters
Standard Deviation 12.60
|
-5.3 Number of letters
Standard Deviation 6.70
|
-3.0 Number of letters
Standard Deviation NA
Since only 1 participant was analyzed, SD will not be applicable.
|
|
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
|
-3.5 Number of letters
Standard Deviation 4.65
|
—
|
|
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 3.30
|
-2.0 Number of letters
Standard Deviation 7.21
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Screening visit) and up to 5 monthsPopulation: Pharmacodynamic subpopulation included participants that were analyzed for PD outcome measures. Only the participants available at the time of assessment were analyzed.
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.
Outcome measures
| Measure |
5 mg/mL TID
n=13 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=12 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=4 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
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
|
-15.3 Microns
Standard Deviation 41.28
|
-168.5 Microns
Standard Deviation 246.78
|
|
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
|
41.1 Microns
Standard Deviation 99.51
|
-18.0 Microns
Standard Deviation 37.40
|
|
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
|
18.3 Microns
Standard Deviation 45.09
|
3.0 Microns
Standard Deviation 47.32
|
|
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
|
31.3 Microns
Standard Deviation 61.36
|
12.0 Microns
Standard Deviation 5.66
|
|
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
|
7.3 Microns
Standard Deviation 45.11
|
16.0 Microns
Standard Deviation NA
No SD can be calculated for one participant analyzed.
|
|
Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months
Previously treated, Month 1
|
46.4 Microns
Standard Deviation 130.30
|
-1.3 Microns
Standard Deviation 27.93
|
36.0 Microns
Standard Deviation NA
No SD can be calculated for one participant analyzed.
|
|
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
|
-10.0 Microns
Standard Deviation 108.19
|
—
|
|
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
|
2.0 Microns
Standard Deviation 37.99
|
—
|
|
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
|
0.3 Microns
Standard Deviation 87.37
|
—
|
|
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
|
3.0 Microns
Standard Deviation 66.43
|
—
|
SECONDARY outcome
Timeframe: Up to 6 weeksPopulation: PD population was planned for analysis of this outcome; however, Data was not collected for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Safety population.
Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.
Outcome measures
| Measure |
5 mg/mL TID
n=19 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
2 mg/mL TID
n=15 Participants
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
5 mg/mL QD
n=8 Participants
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
|
|---|---|---|---|
|
Number of Participants With Lesion Types Over Period
Occult
|
16 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants With Lesion Types Over Period
Minimally classic
|
2 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
5 mg/mL TID
2 mg/mL TID
5 mg/mL QD
Serious adverse events
| Measure |
5 mg/mL TID
n=19 participants at risk
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
2 mg/mL TID
n=15 participants at risk
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
5 mg/mL QD
n=8 participants at risk
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Cataract
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
Other adverse events
| Measure |
5 mg/mL TID
n=19 participants at risk
Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
2 mg/mL TID
n=15 participants at risk
Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.
|
5 mg/mL QD
n=8 participants at risk
Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
|
|---|---|---|---|
|
Eye disorders
Eye pain
|
10.5%
2/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Keratoconjunctivitis sicca
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Macular degeneration
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Retinal disorder
|
10.5%
2/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Retinal haemorrhage
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Blepharitis
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Cataract
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Cataract nuclear
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Dry eye
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Optic disc haemorrhage
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Photopsia
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
12.5%
1/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Posterior capsule opacification
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Visual impairment
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
12.5%
1/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
12.5%
1/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
25.0%
2/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Infections and infestations
Cystitis
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Infections and infestations
Localised infection
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Infections and infestations
Lower respiratory tract infection
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
12.5%
1/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
13.3%
2/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Investigations
Blood cholesterol increased
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Cardiac disorders
Angina pectoris
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
12.5%
1/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
General disorders
Sensation of foreign body
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
6.7%
1/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
0.00%
0/15 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
12.5%
1/8 • AEs and SAEs were collected approximately up to 6 months
Safety Population was used to collect AE and SAE data
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER