Trial Outcomes & Findings for A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure (NCT NCT01173471)
NCT ID: NCT01173471
Last Updated: 2014-02-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline to 4 weeks
Results posted on
2014-02-14
Participant Flow
This multicenter study was conducted in 19 centers in the US, UK, and Sweden between 13 December 2010 and 06 November 2012. A total of 117 patients were screened in the study and of these, 50 were randomized into the double-blind treatment period.
Diagnosis of intra-ocular hypertension (raised IOP), or POAG, with IOP \>20 mmHg and =\<36 mmHg, and currently prescribed a stable dose of one anti-glaucoma medication that began at least 30 days prior to the screening visit or a diagnosis of intra-ocular hypertension, defined as an IOP \>22 mmHg and =\<36 mmHg while not on anti-glaucoma medication.
Participant milestones
| Measure |
Placebo OD
Placebo once daily
|
AZD4017 200 mg OD
AZD4017 200 mg once daily
|
Placebo BID
Placebo twice daily
|
AZD4017 400 mg BID
AZD4017 400 mg twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
18
|
19
|
|
Overall Study
Received Treatment
|
6
|
7
|
18
|
19
|
|
Overall Study
Completed Treatment
|
4
|
7
|
15
|
18
|
|
Overall Study
COMPLETED
|
4
|
7
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo OD
Placebo once daily
|
AZD4017 200 mg OD
AZD4017 200 mg once daily
|
Placebo BID
Placebo twice daily
|
AZD4017 400 mg BID
AZD4017 400 mg twice daily
|
|---|---|---|---|---|
|
Overall Study
Eligibility criteria not fulfilled
|
0
|
0
|
1
|
1
|
|
Overall Study
Condition under investigation worsened
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Reason given as Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase IIa Study to Assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-ocular Pressure
Baseline characteristics by cohort
| Measure |
Placebo OD
n=6 Participants
Placebo once daily
|
AZD4017 200 mg OD
n=7 Participants
AZD4017 200 mg once daily
|
Placebo BID
n=18 Participants
Placebo twice daily
|
AZD4017 400 mg BID
n=19 Participants
AZD4017 400 mg twice daily
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
63 Years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
57 Years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
65 Years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
61 Years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Age, Customized
<50 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Customized
>=50-<65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Stratification factor
Add-on to intra-ocular pressure medication
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Stratification factor
Not on intra-ocular pressure medication
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: Efficacy analysis set
Outcome measures
| Measure |
Placebo OD
n=6 Participants
Placebo once daily
|
AZD4017 200 mg OD
n=7 Participants
AZD4017 200 mg once daily
|
Placebo BID
n=16 Participants
Placebo twice daily
|
AZD4017 400 mg BID
n=19 Participants
AZD4017 400 mg twice daily
|
|---|---|---|---|---|
|
Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
|
0.8 Percentage change
Interval -15.6 to 17.3
|
-0.4 Percentage change
Interval -13.8 to 13.0
|
-8.1 Percentage change
Interval -13.3 to -2.9
|
-11.0 Percentage change
Interval -15.8 to -6.2
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Efficacy analysis set
Outcome measures
| Measure |
Placebo OD
n=6 Participants
Placebo once daily
|
AZD4017 200 mg OD
n=7 Participants
AZD4017 200 mg once daily
|
Placebo BID
n=18 Participants
Placebo twice daily
|
AZD4017 400 mg BID
n=19 Participants
AZD4017 400 mg twice daily
|
|---|---|---|---|---|
|
Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
>= 20% decrease in intra-ocular pressure
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment
>= 30% decrease in intra-ocular pressure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Efficacy analysis set
Outcome measures
| Measure |
Placebo OD
n=6 Participants
Placebo once daily
|
AZD4017 200 mg OD
n=7 Participants
AZD4017 200 mg once daily
|
Placebo BID
n=16 Participants
Placebo twice daily
|
AZD4017 400 mg BID
n=19 Participants
AZD4017 400 mg twice daily
|
|---|---|---|---|---|
|
Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment
|
0.1 mmHg
Interval -4.8 to 4.9
|
-0.4 mmHg
Interval -4.4 to 3.5
|
-1.9 mmHg
Interval -3.3 to -0.6
|
-2.6 mmHg
Interval -3.8 to -1.3
|
Adverse Events
Placebo OD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD4017 200 mg OD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD4017 400 mg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo OD
n=6 participants at risk
Placebo once daily
|
AZD4017 200 mg OD
n=7 participants at risk
AZD4017 200 mg once daily
|
Placebo BID
n=18 participants at risk
Placebo twice daily
|
AZD4017 400 mg BID
n=19 participants at risk
AZD4017 400 mg twice daily
|
|---|---|---|---|---|
|
Infections and infestations
ASYMPTOMATIC BACTERIURIA
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
14.3%
1/7 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Infections and infestations
CONJUNCTIVITIS INFECTIVE
|
16.7%
1/6 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
14.3%
1/7 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Infections and infestations
INFECTED BITES
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.7%
1/6 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
14.3%
1/7 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
14.3%
1/7 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
BLEPHARITIS
|
16.7%
1/6 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
DELLEN
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
DRY EYE
|
16.7%
1/6 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
14.3%
1/7 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Eye disorders
VITREOUS DETACHMENT
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Vascular disorders
FLUSHING
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
28.6%
2/7 • Number of events 2 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Gastrointestinal disorders
LIP PRURITUS
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
SENSATION OF HEAVINESS
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
14.3%
1/7 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
General disorders
FATIGUE
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.6%
1/18 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
33.3%
2/6 • Number of events 2 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/19 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/6 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/7 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
0.00%
0/18 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
5.3%
1/19 • Number of events 1 • 4-week treatment period.
All patients were required to return for a mandatory follow-up visit (Visit 8) between 14 and 21 days, inclusive, after the last dose of study medication. Any ongoing adverse events (AEs) at the follow-up visit were followed until resolution, until the AE stabilized, until it was otherwise explained, or until the patient was lost to follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor recognises that the Trust and Investigator have a responsibility under the Research Governance Framework for Health and Social Care to ensure that results of scientific interest arising from the Clinical Trial are appropriately published and disseminated. Such data will be submitted to the Sponsor for review and comment prior to publication. The Trust agrees, and shall ensure that the Investigator agrees, that all reasonable comments made by the Sponsor will be incorporated.
- Publication restrictions are in place
Restriction type: OTHER