Trial Outcomes & Findings for Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (NCT NCT02510794)
NCT ID: NCT02510794
Last Updated: 2021-05-06
Results Overview
Protocol-Defined Refill Criteria At 1 month after initial fill: * Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: * Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR * Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR * Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
225 participants
Primary outcome timeframe
Baseline up to approximately 38 months
Results posted on
2021-05-06
Participant Flow
Participants with subfoveal neovascularization secondary to AMD diagnosed within 9 months and treated with ITV anti-VEGF agents were enrolled in the study. Written informed consent was obtained before initiation of any study-related procedures. A participant's screening occurred no sooner than 7 days following administration of the last ITV ranibizumab treatment to the study eye. The screening visit was followed by the randomization visit.
Participant milestones
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
62
|
63
|
41
|
|
Overall Study
COMPLETED
|
51
|
56
|
56
|
36
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
7
|
5
|
Reasons for withdrawal
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
2
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
1
|
0
|
|
Overall Study
Participant moved out of the area
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
4
|
3
|
Baseline Characteristics
Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=63 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
194 Participants
n=31 Participants
|
|
Age, Continuous
|
74.6 Years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
75.0 Years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
73.8 Years
STANDARD_DEVIATION 8.1 • n=206 Participants
|
71.9 Years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
74.0 Years
STANDARD_DEVIATION 8.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
146 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
79 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
211 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
220 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 38 monthsPopulation: Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment, excluding 5 participants who were given surgery.
Protocol-Defined Refill Criteria At 1 month after initial fill: * Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: * Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR * Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR * Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Time Until a Participant First Requires the Implant Refill According to Protocol-Defined Refill Criteria
|
8.7 Months
Interval 6.93 to 9.0
|
13.0 Months
Interval 11.76 to 24.61
|
15.8 Months
Interval 12.06 to 20.63
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 9, 10Population: Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations: * At the time of an ITV anti-VEGF injection in study eye prior to Month 10. * Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment. * At the time of explant.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged At Month 9 and 10
|
-3.3 Units on scale
Interval -5.6 to -1.0
|
-0.3 Units on scale
Interval -2.5 to 1.8
|
5.0 Units on scale
Interval 2.8 to 7.2
|
3.2 Units on scale
Interval 0.6 to 5.8
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 10Population: Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations: * At the time of an ITV anti-VEGF injection in study eye prior to Month 10. * Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment. * At the time of explant.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Change From Baseline in BCVA Over Time
Month 7
|
-0.9 Units on scale
Interval -3.2 to 1.4
|
-1.8 Units on scale
Interval -4.0 to 0.3
|
3.9 Units on scale
Interval 1.7 to 6.1
|
3.5 Units on scale
Interval 0.9 to 6.1
|
—
|
|
Change From Baseline in BCVA Over Time
Month 8
|
-2.4 Units on scale
Interval -4.7 to -0.1
|
-1.2 Units on scale
Interval -3.3 to 1.0
|
4.0 Units on scale
Interval 1.8 to 6.2
|
3.3 Units on scale
Interval 0.7 to 5.9
|
—
|
|
Change From Baseline in BCVA Over Time
Month 1
|
-6.6 Units on scale
Interval -11.0 to -2.3
|
-4.7 Units on scale
Interval -8.8 to -0.6
|
-4.9 Units on scale
Interval -9.1 to -0.6
|
2.4 Units on scale
Interval -2.6 to 7.5
|
—
|
|
Change From Baseline in BCVA Over Time
Month 2
|
-2.4 Units on scale
Interval -4.3 to -0.6
|
-1.4 Units on scale
Interval -3.2 to 0.4
|
1.6 Units on scale
Interval -0.2 to 3.5
|
2.0 Units on scale
Interval -0.2 to 4.2
|
—
|
|
Change From Baseline in BCVA Over Time
Month 3
|
-0.7 Units on scale
Interval -2.4 to 1.0
|
-0.6 Units on scale
Interval -2.2 to 1.0
|
2.4 Units on scale
Interval 0.8 to 4.1
|
2.7 Units on scale
Interval 0.7 to 4.7
|
—
|
|
Change From Baseline in BCVA Over Time
Month 4
|
-1.4 Units on scale
Interval -3.4 to 0.7
|
-1.1 Units on scale
Interval -3.0 to 0.8
|
3.1 Units on scale
Interval 1.1 to 5.1
|
1.9 Units on scale
Interval -0.4 to 4.3
|
—
|
|
Change From Baseline in BCVA Over Time
Month 5
|
-1.3 Units on scale
Interval -3.4 to 0.8
|
-0.6 Units on scale
Interval -2.5 to 1.4
|
3.8 Units on scale
Interval 1.8 to 5.8
|
3.0 Units on scale
Interval 0.6 to 5.3
|
—
|
|
Change From Baseline in BCVA Over Time
Month 6
|
-0.4 Units on scale
Interval -3.0 to 2.3
|
-1.7 Units on scale
Interval -4.3 to 0.8
|
3.8 Units on scale
Interval 1.2 to 6.4
|
2.7 Units on scale
Interval -0.4 to 5.7
|
—
|
|
Change From Baseline in BCVA Over Time
Month 9
|
-3.3 Units on scale
Interval -5.7 to -0.9
|
-0.5 Units on scale
Interval -2.7 to 1.7
|
5.0 Units on scale
Interval 2.7 to 7.3
|
3.9 Units on scale
Interval 1.1 to 6.6
|
—
|
|
Change From Baseline in BCVA Over Time
Month 10
|
-3.3 Units on scale
Interval -5.7 to -1.0
|
-0.2 Units on scale
Interval -2.4 to 2.0
|
5.1 Units on scale
Interval 2.8 to 7.3
|
2.5 Units on scale
Interval -0.2 to 5.2
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 10Population: Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment. Assessments are censored for PDS participants meeting the following situations: * At the time of an ITV anti-VEGF injection in study eye prior to Month 10. * Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment. * At the time of explant.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. The minimum score possible is 0 and maximum possible is 100. A higher score represents better functioning. Here, the adjusted mean from MMRM analysis is presented).
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=45 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=60 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=55 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=37 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Adjusted Average Change From Baseline in BCVA Over Time (MMRM Analysis)
|
-7.5 Units on scale
Standard Deviation 74.0
|
-8.5 Units on scale
Standard Deviation 59.1
|
29.7 Units on scale
Standard Deviation 54.7
|
21.3 Units on scale
Standard Deviation 65.1
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Month 9Population: Efficacy Population defined as all participants who received at least one study treatment. Here, "Number of Participants analyzed" indicates Number of Participants Included in MMRM Analysis. Assessments are censored for PDS participants meeting the following situations: * At the time of an ITV anti-VEGF injection in study eye prior to Month 10. * Prohibited therapy other than oral corticosteroids more than 10 mg/day or any fellow eye treatment. * At the time of explant.
Central foveal thickness (CFT) is defined as the retinal thickness in the center of the fovea
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 7
|
39.9 microns
Interval 25.6 to 54.3
|
0.7 microns
Interval -12.5 to 14.0
|
-4.3 microns
Interval -18.3 to 9.6
|
-9.8 microns
Interval -25.9 to 6.3
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 8
|
42.8 microns
Interval 26.4 to 59.1
|
3.1 microns
Interval -12.1 to 18.3
|
5.1 microns
Interval -10.6 to 20.8
|
-2.4 microns
Interval -20.8 to 16.1
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 9
|
54.8 microns
Interval 37.1 to 72.4
|
-0.7 microns
Interval -16.9 to 15.5
|
-1.7 microns
Interval -18.5 to 15.1
|
-6.3 microns
Interval -26.1 to 13.4
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 1
|
16.5 microns
Interval 4.1 to 29.0
|
7.2 microns
Interval -4.5 to 18.9
|
-2.9 microns
Interval -15.1 to 9.2
|
2.5 microns
Interval -11.7 to 16.7
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 2
|
19.8 microns
Interval 6.9 to 32.7
|
11.9 microns
Interval -0.3 to 24.1
|
-1.8 microns
Interval -14.5 to 10.9
|
1.5 microns
Interval -13.3 to 16.4
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 3
|
24.9 microns
Interval 11.5 to 38.3
|
7.3 microns
Interval -5.5 to 20.0
|
6.4 microns
Interval -6.8 to 19.6
|
-7.3 microns
Interval -22.9 to 8.3
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 4
|
31.0 microns
Interval 15.8 to 46.1
|
4.1 microns
Interval -10.3 to 18.5
|
1.9 microns
Interval -13.2 to 16.9
|
-1.7 microns
Interval -19.2 to 15.9
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 5
|
30.9 microns
Interval 16.1 to 45.7
|
0.4 microns
Interval -13.6 to 14.5
|
8.0 microns
Interval -6.7 to 22.9
|
4.0 microns
Interval -13.0 to 21.1
|
—
|
|
Change From Baseline in Central Foveal Thickness (CFT) Over Time as Assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT)
Month 6
|
31.9 microns
Interval 15.6 to 48.1
|
2.1 microns
Interval -13.1 to 17.3
|
5.9 microns
Interval -10.0 to 21.7
|
-2.0 microns
Interval -20.4 to 16.4
|
—
|
SECONDARY outcome
Timeframe: Month 9Population: Efficacy Population defined as all participants who were randomly assigned to study treatment and received at least one study treatment.
Removed implants identified as meeting serum PK criteria for possible clogging were assessed via lab-based investigation (in vitro drug release testing) to determine whether there was any implant clogging.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Number of Implant Clogging at Month 9
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour) on Day 1 up to 38 monthsPopulation: PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)
The serum pharmacokinetics of ranibizumab were characterized by estimating Cmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=16 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=25 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=27 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Observed Maximum Serum Concentration (Cmax) of Ranibizumab
Interval following implant insertion before first refill
|
105.52 pg/mL
Geometric Coefficient of Variation 258.0
|
220.87 pg/mL
Geometric Coefficient of Variation 46.4
|
1080.69 pg/mL
Geometric Coefficient of Variation 272.5
|
—
|
—
|
|
Observed Maximum Serum Concentration (Cmax) of Ranibizumab
All Dose Intervals
|
91.47 pg/mL
Geometric Coefficient of Variation 187.2
|
297.61 pg/mL
Geometric Coefficient of Variation 115.2
|
1131.01 pg/mL
Geometric Coefficient of Variation 256.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour) on Day 1 up to approximately 38 months (detailed timeframe is provided in description field)Population: PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)
AUCLast is defined as area under the concentration-time curve from dosing (implant or refill) to last observation before next refill or exiting the study. The serum pharmacokinetics of ranibizumab were characterized by estimating AUC between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=16 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=25 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=27 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab
Interval following implant insertion before first refill
|
5.89 ng∙day/mL
Geometric Coefficient of Variation 225.1
|
28.39 ng∙day/mL
Geometric Coefficient of Variation 107.6
|
90.83 ng∙day/mL
Geometric Coefficient of Variation 64.7
|
—
|
—
|
|
Area Under the Concentration-Time Curve From Dosing to Last Observation (AUClast) of Ranibizumab
All Dose Intervals
|
3.43 ng∙day/mL
Geometric Coefficient of Variation 176.8
|
22.93 ng∙day/mL
Geometric Coefficient of Variation 96.9
|
66.12 ng∙day/mL
Geometric Coefficient of Variation 71.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour) on Day 1 up to 38 monthsPopulation: PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)
The serum pharmacokinetics of ranibizumab were characterized by estimating Tmax between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=16 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=25 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=27 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Ranibizumab
Interval following implant insertion before first refill
|
11.45 days
Interval 0.0 to 688.1
|
12.87 days
Interval 0.0 to 86.0
|
29.01 days
Interval 0.8 to 180.3
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of Ranibizumab
All Dose Intervals
|
4.87 days
Interval 0.0 to 688.1
|
6.71 days
Interval 0.0 to 91.1
|
6.97 days
Interval 0.8 to 180.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour) on Day 1 up to 38 monthsPopulation: PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)
The serum pharmacokinetics of ranibizumab were characterized by estimating t1/2 between dose intervals. Estimates for these parameters were tabulated and summarized by descriptive statistics.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=16 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=25 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=27 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Ranibizumab
Interval following implant insertion before first refill
|
168.20 days
Geometric Coefficient of Variation 163.3
|
88.30 days
Geometric Coefficient of Variation 46.7
|
119.07 days
Geometric Coefficient of Variation 128.4
|
—
|
—
|
|
Terminal Half-Life (t1/2) of Ranibizumab
All Dose Intervals
|
162.36 days
Geometric Coefficient of Variation 129.3
|
118.87 days
Geometric Coefficient of Variation 76.2
|
143.87 days
Geometric Coefficient of Variation 171.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hour) on Day 1 up to 38 monthsPopulation: PK Population with exclusion (randomized participants who had received at least one study drug administration and provided at least one serum and/or aqueous PK sample for determination of ranibizumab concentration excluding participants who had prior intravitreal bevacizumab, received fellow eye ranibizumab treatment, and/or received supplemental intravitreal ranibizumab)
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=16 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=25 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=27 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab
Interval following implant insertion before first refill
|
14.96 pg/mL
Geometric Coefficient of Variation 76.4
|
61.64 pg/mL
Geometric Coefficient of Variation 95.8
|
129.63 pg/mL
Geometric Coefficient of Variation 149.2
|
—
|
—
|
|
Observed Steady-State Serum Concentration at the End of a Dosing Interval (Ctrough) of Ranibizumab
All Dose Intervals
|
11.58 pg/mL
Geometric Coefficient of Variation 65.7
|
105.07 pg/mL
Geometric Coefficient of Variation 77.4
|
62.19 pg/mL
Geometric Coefficient of Variation 345.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to approximately Month 38Population: Safety analyses were based on the Safety Population which was composed of participants receiving at least one study treatment.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=179 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Participants with ocular AEs in study eye
|
56 Participants
|
58 Participants
|
52 Participants
|
166 Participants
|
26 Participants
|
|
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Participants with non-ocular AEs
|
46 Participants
|
52 Participants
|
52 Participants
|
150 Participants
|
36 Participants
|
|
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Participants with ocular SAEs in study eye
|
7 Participants
|
6 Participants
|
4 Participants
|
17 Participants
|
0 Participants
|
|
Number of Participants With Ocular and Non-Ocular Adverse Events (AEs) and Serious AEs (SAEs)
Participants with non-ocular SAEs
|
8 Participants
|
16 Participants
|
13 Participants
|
37 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 38 monthsPopulation: Safety analyses were based on the Safety Population which was composed of participants receiving at least one study treatment. Here, number of analyzed participants represents number of participants from whom samples were collected and analyzed. Baseline evaluable participant is a participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant is a participant with an ADA assay result from at least one post-baseline sample.
Outcome measures
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 Participants
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 Participants
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 Participants
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=179 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 Participants
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Positive Serum Antibodies to Ranibizumab
Participants with a positive sample at time of entry into the study (Baseline)
|
10.3 Percentage of Participants
|
5.0 Percentage of Participants
|
5.1 Percentage of Participants
|
6.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Positive Serum Antibodies to Ranibizumab
Participants positive for Treatment Emergent ADA (Post-baseline)
|
6.9 Percentage of Participants
|
14.5 Percentage of Participants
|
15.3 Percentage of Participants
|
12.3 Percentage of Participants
|
14.6 Percentage of Participants
|
Adverse Events
Port Delivery System With Ranibizumab 10mg/mL
Serious events: 14 serious events
Other events: 57 other events
Deaths: 1 deaths
Port Delivery System With Ranibizumab 40mg/mL
Serious events: 19 serious events
Other events: 59 other events
Deaths: 2 deaths
Port Delivery System With Ranibizumab 100mg/mL
Serious events: 17 serious events
Other events: 58 other events
Deaths: 1 deaths
Intravitreal Injection With Ranibizumab 0.5mg
Serious events: 4 serious events
Other events: 35 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 participants at risk
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 participants at risk
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 participants at risk
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 participants at risk
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
APLASTIC ANAEMIA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CONJUNCTIVAL EROSION
|
1.7%
1/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
HYPOTONY OF EYE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
RETINAL TEAR
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
RETINOPATHY PROLIFERATIVE
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
RHEGMATOGENOUS RETINAL DETACHMENT
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
TRACTIONAL RETINAL DETACHMENT
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VISION BLURRED
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
General disorders
CHEST PAIN
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
ENDOPHTHALMITIS
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
PNEUMONIA
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.5%
4/62 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
CONJUNCTIVAL FILTERING BLEB LEAK
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
CONJUNCTIVAL RETRACTION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
FRACTURE DISPLACEMENT
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
HYPHAEMA
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
ILIOTIBIAL BAND SYNDROME
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
OCULAR PROCEDURAL COMPLICATION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
PERIPROSTHETIC FRACTURE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
WOUND SECRETION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DISORDER
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER RECURRENT
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
HYPERTENSIVE ENCEPHALOPATHY
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Product Issues
DEVICE DISLOCATION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Product Issues
DEVICE MALFUNCTION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Vascular disorders
FEMORAL ARTERY ANEURYSM
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
Other adverse events
| Measure |
Port Delivery System With Ranibizumab 10mg/mL
n=58 participants at risk
Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 40mg/mL
n=62 participants at risk
Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Port Delivery System With Ranibizumab 100mg/mL
n=59 participants at risk
Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria.
|
Intravitreal Injection With Ranibizumab 0.5mg
n=41 participants at risk
Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter.
|
|---|---|---|---|---|
|
Eye disorders
ANTERIOR CHAMBER CELL
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
10.2%
6/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
ANTERIOR CHAMBER FLARE
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
BLEPHARITIS
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CATARACT
|
5.2%
3/58 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.1%
5/62 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
20.3%
12/59 • Number of events 16 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
12.2%
5/41 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CATARACT CORTICAL
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CATARACT NUCLEAR
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CHOROIDAL DETACHMENT
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CHOROIDAL NEOVASCULARISATION
|
6.9%
4/58 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CONJUNCTIVAL BLEB
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
70.7%
41/58 • Number of events 53 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
71.0%
44/62 • Number of events 54 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
62.7%
37/59 • Number of events 38 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
19.5%
8/41 • Number of events 11 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
31.0%
18/58 • Number of events 20 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
21.0%
13/62 • Number of events 14 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
23.7%
14/59 • Number of events 16 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CONJUNCTIVAL OEDEMA
|
10.3%
6/58 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
9.7%
6/62 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
CORNEAL OEDEMA
|
10.3%
6/58 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
DERMATOCHALASIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
DIPLOPIA
|
5.2%
3/58 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
DRY EYE
|
12.1%
7/58 • Number of events 10 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.5%
5/59 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
EYE DISCHARGE
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
EYE IRRITATION
|
15.5%
9/58 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
11.3%
7/62 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
11.9%
7/59 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.9%
2/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
EYE PAIN
|
20.7%
12/58 • Number of events 16 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
19.4%
12/62 • Number of events 15 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
25.4%
15/59 • Number of events 18 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
12.2%
5/41 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
EYELID OEDEMA
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
EYELID PTOSIS
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
EYELIDS PRURITUS
|
6.9%
4/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES
|
6.9%
4/58 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
11.3%
7/62 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
11.9%
7/59 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
IRIDOCYCLITIS
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
IRITIS
|
13.8%
8/58 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
21.0%
13/62 • Number of events 14 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
11.9%
7/59 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
LACRIMATION INCREASED
|
5.2%
3/58 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
MACULAR DEGENERATION
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
|
13.8%
8/58 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
16.1%
10/62 • Number of events 10 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
16.9%
10/59 • Number of events 12 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
PHOTOPHOBIA
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.5%
4/62 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
POSTERIOR CAPSULE OPACIFICATION
|
6.9%
4/58 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.1%
5/62 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.5%
5/59 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
12.2%
5/41 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
PUNCTATE KERATITIS
|
8.6%
5/58 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
10.3%
6/58 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
9.7%
6/62 • Number of events 11 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.5%
5/59 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VISION BLURRED
|
13.8%
8/58 • Number of events 11 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.5%
5/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
3.4%
2/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VITREOUS DETACHMENT
|
12.1%
7/58 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
9.7%
6/62 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
17.1%
7/41 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VITREOUS DISORDER
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VITREOUS FLOATERS
|
22.4%
13/58 • Number of events 13 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
14.5%
9/62 • Number of events 13 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
20.3%
12/59 • Number of events 15 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
9.8%
4/41 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Eye disorders
VITREOUS HAEMORRHAGE
|
6.9%
4/58 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.1%
5/62 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Gastrointestinal disorders
NAUSEA
|
8.6%
5/58 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.5%
4/62 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
General disorders
CHEST PAIN
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
General disorders
FATIGUE
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
BRONCHITIS
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
14.5%
9/62 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
12.2%
5/41 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
EAR INFECTION
|
6.9%
4/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
HORDEOLUM
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
INFLUENZA
|
8.6%
5/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.7%
12/58 • Number of events 17 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
12.9%
8/62 • Number of events 15 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
15.3%
9/59 • Number of events 11 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
14.6%
6/41 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
SINUSITIS
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.1%
5/62 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
15.3%
9/59 • Number of events 11 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
17.1%
7/41 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
TOOTH INFECTION
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
9.7%
6/62 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.6%
5/58 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
16.1%
10/62 • Number of events 17 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
10.2%
6/59 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.5%
5/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
CORNEAL ABRASION
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
FALL
|
8.6%
5/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
HYPHAEMA
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
8.5%
5/59 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.5%
4/62 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Investigations
INTRAOCULAR PRESSURE DECREASED
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
13.8%
8/58 • Number of events 14 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
10.2%
6/59 • Number of events 8 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
10.2%
6/59 • Number of events 7 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
1.6%
1/62 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.7%
1/58 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
10.2%
6/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
9.8%
4/41 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.5%
4/62 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.4%
2/58 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.8%
4/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
6.9%
4/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
6.5%
4/62 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Nervous system disorders
HEADACHE
|
15.5%
9/58 • Number of events 10 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
12.9%
8/62 • Number of events 9 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
18.6%
11/59 • Number of events 11 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Renal and urinary disorders
HYPERTONIC BLADDER
|
5.2%
3/58 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/59 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/41 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.9%
4/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.8%
3/62 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/58 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
0.00%
0/62 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
5.1%
3/59 • Number of events 4 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
|
Vascular disorders
HYPERTENSION
|
8.6%
5/58 • Number of events 5 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
3.2%
2/62 • Number of events 2 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
10.2%
6/59 • Number of events 6 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately Month 38
Number of events includes all occurrences. Table summary includes adverse events that started or worsened (for existing condition) on or after the date of first study treatment during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER