Trial Outcomes & Findings for Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (NCT NCT00436553)
NCT ID: NCT00436553
Last Updated: 2011-04-19
Results Overview
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2011-04-19
Participant Flow
Participant milestones
| Measure |
Verteporfin SF + Ranibizumab
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
105
|
112
|
|
Overall Study
COMPLETED
|
91
|
93
|
102
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
10
|
Reasons for withdrawal
| Measure |
Verteporfin SF + Ranibizumab
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
4
|
|
Overall Study
Death
|
3
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
3
|
Baseline Characteristics
Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Baseline characteristics by cohort
| Measure |
Verteporfin SF + Ranibizumab
n=104 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=105 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=112 Participants
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
77.5 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
77.4 years
STANDARD_DEVIATION 8.48 • n=7 Participants
|
77.2 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
77.3 years
STANDARD_DEVIATION 8.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) was utilized.
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
Outcome measures
| Measure |
Verteporfin SF + Ranibizumab
n=103 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=104 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=110 Participants
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12
Baseline
|
53.7 Letters
Standard Deviation 13.52
|
54.6 Letters
Standard Deviation 12.78
|
54.8 Letters
Standard Deviation 13.55
|
|
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12
Month 12
|
59.0 Letters
Standard Deviation 17.47
|
59.0 Letters
Standard Deviation 18.03
|
63.0 Letters
Standard Deviation 18.88
|
|
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12
Change from baseline
|
5.3 Letters
Standard Deviation 15.66
|
4.4 Letters
Standard Deviation 15.47
|
8.1 Letters
Standard Deviation 15.09
|
PRIMARY outcome
Timeframe: Month 2 up to Month 11Population: Full analysis set (FAS) - Only the combination groups were analyzed. The percent of subjects with a ranibizumab treatment-free interval of at least 3 months duration following the Month 2 ranibizumab treatment was calculated using the subjects still in the study at Month 5.
The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.
Outcome measures
| Measure |
Verteporfin SF + Ranibizumab
n=95 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=97 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit
|
92.6 Percent of participants
Interval 85.4 to 97.0
|
83.5 Percent of participants
Interval 74.6 to 90.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis set (FAS), observed data.
Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Outcome measures
| Measure |
Verteporfin SF + Ranibizumab
n=67 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=66 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=78 Participants
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Change From Baseline in Total Area of Leakage of the Study Eye at Month 12
Baseline
|
6.654 mm^2
Standard Deviation 4.0956
|
6.211 mm^2
Standard Deviation 5.0618
|
6.931 mm^2
Standard Deviation 4.6473
|
|
Change From Baseline in Total Area of Leakage of the Study Eye at Month 12
Month 12
|
3.472 mm^2
Standard Deviation 4.2340
|
3.024 mm^2
Standard Deviation 4.0188
|
3.177 mm^2
Standard Deviation 4.9930
|
|
Change From Baseline in Total Area of Leakage of the Study Eye at Month 12
Change from Baseline
|
-3.182 mm^2
Standard Deviation 4.9729
|
-3.187 mm^2
Standard Deviation 5.9744
|
-3.753 mm^2
Standard Deviation 5.8005
|
SECONDARY outcome
Timeframe: Month 12Population: Full analysis set (FAS), observed data.
The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Outcome measures
| Measure |
Verteporfin SF + Ranibizumab
n=67 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=66 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=79 Participants
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12
|
58.2 Percentage of participants
0
|
54.5 Percentage of participants
0
|
41.8 Percentage of participants
0
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis set (FAS), observed data.
Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.
Outcome measures
| Measure |
Verteporfin SF + Ranibizumab
n=76 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=80 Participants
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=89 Participants
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness at Month 12
Change from Baseline
|
-151.733 micrometer
Standard Deviation 135.6200
|
-140.919 micrometer
Standard Deviation 128.0741
|
-172.238 micrometer
Standard Deviation 166.6691
|
|
Change From Baseline in Central Retinal Thickness at Month 12
Baseline
|
444.654 micrometer
Standard Deviation 137.7119
|
446.638 micrometer
Standard Deviation 129.5482
|
456.824 micrometer
Standard Deviation 153.4270
|
|
Change From Baseline in Central Retinal Thickness at Month 12
Month 12
|
292.921 micrometer
Standard Deviation 79.2733
|
305.719 micrometer
Standard Deviation 80.4508
|
284.586 micrometer
Standard Deviation 75.4892
|
Adverse Events
Verteporfin SF + Ranibizumab
Serious events: 32 serious events
Other events: 85 other events
Deaths: 0 deaths
Verteporfin RF + Ranibizumab
Serious events: 29 serious events
Other events: 81 other events
Deaths: 0 deaths
Ranibizumab Monotherapy
Serious events: 41 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verteporfin SF + Ranibizumab
n=104 participants at risk
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=106 participants at risk
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=111 participants at risk
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer recurrent
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.7%
3/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Coronary artery disease
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Myocardial infarction
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Cardiac disorders
Tachycardia
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Choroidal infarction (Study eye)
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Eye pain (Study eye)
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Macular hole (Study eye)
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Macular oedema (Study eye)
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Retinal artery occlusion (Fellow eye)
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Retinal artery occlusion (Study eye)
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
3.8%
4/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.7%
3/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.8%
2/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
General disorders
Asthenia
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
General disorders
Chest pain
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
General disorders
Pyrexia
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Immune system disorders
Iodine allergy
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Breast cellulitis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Endophthalmitis (Study eye)
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.8%
2/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Gangrene
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.8%
2/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Labyrinthitis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Lobar pneumonia
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.8%
3/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.6%
4/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Sepsis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Investigations
Weight decreased
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.8%
2/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.7%
3/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Psychiatric disorders
Completed suicide
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Psychiatric disorders
Depression
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Renal and urinary disorders
Haematuria
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Renal and urinary disorders
Urinary retention
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Deep vein thrombosis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Hypotension
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Iliac artery stenosis
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Orthostatic hypotension
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Vascular insufficiency
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
Other adverse events
| Measure |
Verteporfin SF + Ranibizumab
n=104 participants at risk
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Verteporfin RF + Ranibizumab
n=106 participants at risk
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
|
Ranibizumab Monotherapy
n=111 participants at risk
Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.6%
7/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.5%
5/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Blepharitis (Study eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.8%
3/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.5%
5/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Cataract (Fellow eye)
|
3.8%
4/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.8%
4/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Cataract (Study eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.2%
8/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Choroidal neovascularisation (Fellow eye)
|
6.7%
7/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
11.3%
12/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.2%
8/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
12.5%
13/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
17.0%
18/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
16.2%
18/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Eye pain (Study eye)
|
21.2%
22/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
13.2%
14/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
12.6%
14/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Foreign body sensation in eyes (Study eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.5%
5/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Lacrimation increased (Study eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
9.0%
10/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Macular degeneration (Fellow eye)
|
7.7%
8/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
10.8%
12/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Macular oedema (Study eye)
|
4.8%
5/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.6%
7/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Maculopathy (Study eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.8%
4/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.8%
2/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Myodesopsia (Study eye)
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
10.4%
11/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
9.0%
10/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Ocular hyperaemia (Study eye)
|
7.7%
8/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.8%
4/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.2%
8/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Retinal haemorrhage (Fellow eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.7%
5/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
6.7%
7/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
8.5%
9/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.2%
8/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Retinal oedema (Study eye)
|
7.7%
8/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.8%
4/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.7%
3/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Visual acuity reduced (Fellow eye)
|
4.8%
5/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.8%
2/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
9.6%
10/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
8.5%
9/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.5%
5/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Eye disorders
Vitreous detachment (Study eye)
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.7%
5/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.6%
4/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
3/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
5/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.8%
3/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
9/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.5%
8/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
General disorders
Fatigue
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.8%
3/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
General disorders
Oedema peripheral
|
3.8%
4/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.8%
3/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Bronchitis
|
7.7%
8/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.7%
3/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
10/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
11.7%
13/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Sinusitis
|
4.8%
5/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.5%
8/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.6%
11/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
9.4%
10/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
7/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.6%
7/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
8.1%
9/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Corneal abrasion (Study eye)
|
0.00%
0/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
7/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
3.8%
4/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
8.1%
9/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Injury, poisoning and procedural complications
Procedural pain (Study eye)
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.7%
3/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
4/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.6%
7/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
7.2%
8/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.6%
7/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.5%
5/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
6.7%
7/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.94%
1/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.90%
1/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Dizziness
|
5.8%
6/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
0.00%
0/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Nervous system disorders
Headache
|
6.7%
7/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.7%
5/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Psychiatric disorders
Anxiety
|
1.9%
2/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
4.7%
5/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
6.3%
7/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
4/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
2.8%
3/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.96%
1/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.7%
6/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Hypertension
|
8.7%
9/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
12.3%
13/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
10.8%
12/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
|
Vascular disorders
Hypotension
|
3.8%
4/104 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
1.9%
2/106 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
5.4%
6/111 • Cumulative up to Month 24
The Safety set consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. One patient was not treated as randomized. The safety data set includes patients as they were treated.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or until the publication of the trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER