Trial Outcomes & Findings for DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact (NCT NCT00789477)
NCT ID: NCT00789477
Last Updated: 2014-09-09
Results Overview
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
221 participants
Primary outcome timeframe
At week 24
Results posted on
2014-09-09
Participant Flow
A total of 221 participants were randomized at 39 sites in the US, Canada, and Austria. After the 1 year treatment period, participants were to be followed for safety in a 6 mo. follow-up phase. The last visit for this study occurred in September, 2010.
The study population consisted of men and women aged 18 or older with clinically significant diabetic macular edema (DME) with central involvement, and a best corrected visual acuity (BCVA) of 20/40 to 20/320 (letter score of 73 to 24) in the study eye.
Participant milestones
| Measure |
Laser Photocoagulation
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
44
|
44
|
45
|
|
Overall Study
Participants Received Treatment
|
44
|
44
|
44
|
42
|
45
|
|
Overall Study
COMPLETED
|
33
|
38
|
33
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
11
|
10
|
7
|
Reasons for withdrawal
| Measure |
Laser Photocoagulation
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
2
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
3
|
3
|
1
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
2
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
4
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
0
|
1
|
3
|
0
|
Baseline Characteristics
DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
Baseline characteristics by cohort
| Measure |
Laser Photocoagulation
n=44 Participants
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 10.70 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 11.49 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 8.66 • n=21 Participants
|
62.3 years
STANDARD_DEVIATION 9.92 • n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
129 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: At week 24Population: The FAS was used for the primary efficacy analysis. It included patients as randomized.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Outcome measures
| Measure |
Laser Photocoagulation
n=44 Participants
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
|
2.5 letters correctly read
Standard Deviation 16.14
|
8.6 letters correctly read
Standard Deviation 14.64
|
11.4 letters correctly read
Standard Deviation 8.67
|
8.5 letters correctly read
Standard Deviation 7.50
|
10.3 letters correctly read
Standard Deviation 7.52
|
SECONDARY outcome
Timeframe: At week 52Population: FAS
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Outcome measures
| Measure |
Laser Photocoagulation
n=44 Participants
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Change in BCVA From Baseline to Week 52 - LOCF
|
-1.3 letters correctly read
Standard Deviation 20.72
|
11.0 letters correctly read
Standard Deviation 15.40
|
13.1 letters correctly read
Standard Deviation 10.54
|
9.7 letters correctly read
Standard Deviation 8.93
|
12.0 letters correctly read
Standard Deviation 11.09
|
SECONDARY outcome
Timeframe: At week 24 and week 52Population: FAS
Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Outcome measures
| Measure |
Laser Photocoagulation
n=44 Participants
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF
At week 24
|
9 participants
135.17
|
15 participants
110.65
|
14 participants
143.04
|
7 participants
141.78
|
12 participants
132.17
|
|
Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF
At week 52
|
5 participants
|
18 participants
|
20 participants
|
10 participants
|
19 participants
|
SECONDARY outcome
Timeframe: At week 24 and week 52Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Outcome measures
| Measure |
Laser Photocoagulation
n=43 Participants
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF
At week 24
|
-67.9 microns
Standard Deviation 135.17
|
-144.6 microns
Standard Deviation 110.65
|
-194.5 microns
Standard Deviation 143.04
|
-127.3 microns
Standard Deviation 141.78
|
-153.3 microns
Standard Deviation 132.17
|
|
Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF
At week 52
|
-58.4 microns
Standard Deviation 177.60
|
-165.4 microns
Standard Deviation 135.72
|
-227.4 microns
Standard Deviation 148.96
|
-187.8 microns
Standard Deviation 135.01
|
-180.3 microns
Standard Deviation 124.43
|
SECONDARY outcome
Timeframe: Week 1 to week 48Population: For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.
Outcome measures
| Measure |
Laser Photocoagulation
n=44 Participants
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 Participants
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Number of Focal Laser Treatments
|
2.5 Treatments
Standard Deviation 0.87
|
0.8 Treatments
Standard Deviation 0.93
|
0.5 Treatments
Standard Deviation 0.66
|
0.8 Treatments
Standard Deviation 0.86
|
0.7 Treatments
Standard Deviation 0.77
|
Adverse Events
Laser Photocoagulation
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
Serious events: 14 serious events
Other events: 22 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
Serious events: 13 serious events
Other events: 22 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
Serious events: 12 serious events
Other events: 26 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laser Photocoagulation
n=44 participants at risk
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 participants at risk
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 participants at risk
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 participants at risk
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 participants at risk
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Infections and infestations
Abscess
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Blood pressure increased
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Chest pain
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Corneal abrasion
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Cystitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Device occlusion
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Diabetic retinal oedema
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Gangrene
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Headache
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Hypertensive emergency
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Hypotension
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Injury, poisoning and procedural complications
Joint capsule rupture
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Localised infection
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Maculopathy
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Multi-organ failure
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Parotitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Pyrexia
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage IV
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Retinal tear
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Sepsis
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Sick sinus syndrome
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Sudden death
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Uveitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Visual acuity reduced
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Vitreous haemorrhage
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
Other adverse events
| Measure |
Laser Photocoagulation
n=44 participants at risk
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4
n=44 participants at risk
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
n=44 participants at risk
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
n=42 participants at risk
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
|
Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
n=45 participants at risk
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
|
|---|---|---|---|---|---|
|
Investigations
Blood urine present
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Bronchitis
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.5%
4/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.1%
5/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Blepharitis
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Blood glucose increased
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
14.3%
6/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
13.3%
6/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Blood potassium increased
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Blood pressure increased
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Cataract
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.1%
5/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Conjunctival haemorrhage
|
18.2%
8/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
27.3%
12/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
15.9%
7/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
35.7%
15/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
28.9%
13/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Eye pain
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
13.6%
6/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
14.3%
6/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
15.6%
7/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Foreign body sensation in eye
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Glucose urine present
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
8.9%
4/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Glycosylated haemoglobin increased
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
13.6%
6/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.9%
5/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Haematocrit decreased
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Haemoglobin decreased
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Vascular disorders
Hypertension
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
14.3%
6/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.1%
5/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Intraocular pressure increased
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
13.6%
6/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
13.6%
6/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.9%
5/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Macular oedema
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Maculopathy
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.5%
4/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.5%
4/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
8.9%
4/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Ocular hyperaemia
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
General disorders
Oedema peripheral
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Posterior capsule opacification
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Protein urine present
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.5%
4/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Punctate keratitis
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Retinal aneurysm
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Retinal haemorrhage
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
8.9%
4/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Retinal neovascularisation
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Retinal exudates
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.7%
3/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Vision blurred
|
2.3%
1/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
9.1%
4/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Vitreous detachment
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
7.1%
3/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Vitreous floaters
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
6.8%
3/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.8%
2/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.4%
2/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
|
Eye disorders
Vitreous haemorrhage
|
11.4%
5/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
0.00%
0/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
4.5%
2/44 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.4%
1/42 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
2.2%
1/45 • Day 1 to week 52
Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Not less than 45 days prior to submission of a publication (S)ponsor shall be provided with a copy of the publication. The parties shall discuss any comments submitted by S regarding content, \& Institution \& PI shall delete any confidential information that S requests to be deleted. In addition, since the study is being conducted at multiple sites, parties agreed that publication of results shall be made only as part of a publication of the results obtained by all sites performing the study.
- Publication restrictions are in place
Restriction type: OTHER