Trial Outcomes & Findings for Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy (NCT NCT00674323)
NCT ID: NCT00674323
Last Updated: 2011-04-19
Results Overview
Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Month 6
Results posted on
2011-04-19
Participant Flow
Participant milestones
| Measure |
Verteporfin and Ranibizumab
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Verteporfin and Ranibizumab
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy
Baseline characteristics by cohort
| Measure |
Verteporfin and Ranibizumab
n=19 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
63.8 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 9.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.
Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.
Outcome measures
| Measure |
Verteporfin and Ranibizumab
n=18 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)
|
14 Participants
|
15 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline through end of study (6 months)Population: Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. Last Observation Carried Forward (LOCF) was utilized.
Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.
Outcome measures
| Measure |
Verteporfin and Ranibizumab
n=18 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA
|
15 Participants
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. LOCF was utilized.
High resolution 6 meridian scans were performed to measure central retinal thickness.
Outcome measures
| Measure |
Verteporfin and Ranibizumab
n=18 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)
Baseline
|
324.1 micrometers
Standard Deviation 112.72
|
285.3 micrometers
Standard Deviation 105.64
|
268.5 micrometers
Standard Deviation 97.84
|
|
Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)
Change from Baseline at month 6
|
-145.6 micrometers
Standard Deviation 118.97
|
-98.1 micrometers
Standard Deviation 104.33
|
-65.7 micrometers
Standard Deviation 114.32
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS) included all patients randomized that received at least 1 application of study drug and had at least 1 post-baseline assessment of ICGA. 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 and Ranibizumab
n=18 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 Participants
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6
Baseline
|
59.8 Letters
Standard Deviation 16.21
|
57.2 Letters
Standard Deviation 12.76
|
49.0 Letters
Standard Deviation 18.05
|
|
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6
Change from Baseline at Month 6
|
10.9 Letters
Standard Deviation 10.92
|
7.5 Letters
Standard Deviation 10.65
|
9.2 Letters
Standard Deviation 12.39
|
Adverse Events
Verteporfin and Ranibizumab
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Verteporfin Monotherapy
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Ranibizumab Monotherapy
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verteporfin and Ranibizumab
n=19 participants at risk
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 participants at risk
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 participants at risk
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/19
|
0.00%
0/21
|
4.8%
1/21
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/19
|
4.8%
1/21
|
0.00%
0/21
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/19
|
4.8%
1/21
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19
|
0.00%
0/21
|
4.8%
1/21
|
Other adverse events
| Measure |
Verteporfin and Ranibizumab
n=19 participants at risk
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
|
Verteporfin Monotherapy
n=21 participants at risk
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
|
Ranibizumab Monotherapy
n=21 participants at risk
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on ICGA, and assessment of fluorescein angiograms and visual acuity.
|
|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia (Study eye)
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Eye disorders
Dry eye (Study eye)
|
5.3%
1/19
|
4.8%
1/21
|
0.00%
0/21
|
|
Eye disorders
Macular oedema (Study eye)
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Eye disorders
Polypoidal choroidal vasculopathy (Fellow eye)
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
10.5%
2/19
|
14.3%
3/21
|
0.00%
0/21
|
|
Eye disorders
Visual impairment (Study eye)
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Toothache
|
10.5%
2/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19
|
0.00%
0/21
|
4.8%
1/21
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19
|
19.0%
4/21
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Macular scar (Study eye)
|
5.3%
1/19
|
0.00%
0/21
|
4.8%
1/21
|
|
Investigations
Blood pressure increased
|
5.3%
1/19
|
4.8%
1/21
|
4.8%
1/21
|
|
Investigations
Intraocular pressure increased (Study eye)
|
5.3%
1/19
|
4.8%
1/21
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.3%
1/19
|
0.00%
0/21
|
0.00%
0/21
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.3%
1/19
|
4.8%
1/21
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19
|
0.00%
0/21
|
0.00%
0/21
|
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.
- Publication restrictions are in place
Restriction type: OTHER