Trial Outcomes & Findings for Prostaglandin E1 in Outpatients With Intermittent Claudication (NCT NCT01263925)
NCT ID: NCT01263925
Last Updated: 2014-10-27
Results Overview
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
561 participants
Primary outcome timeframe
From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Results posted on
2014-10-27
Participant Flow
Of the 607 screened subjects, 561 have been randomized. Of these 561 randomized subjects, 541 are included in the Full Analysis Set (FAS). FAS includes all randomized subjects who received at least one dose of trial medication and who have at least one valid measurement of pain-free walking distance under therapy.
Participant Flow shows all randomized subjects. Baseline Characteristics refer to the FAS.
Participant milestones
| Measure |
Alprostadil
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
276
|
285
|
|
Overall Study
Full Analysis Set
|
269
|
272
|
|
Overall Study
COMPLETED
|
225
|
233
|
|
Overall Study
NOT COMPLETED
|
51
|
52
|
Reasons for withdrawal
| Measure |
Alprostadil
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Adverse Event
|
23
|
22
|
|
Overall Study
Unsatisfactory Compliance of Subject
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
|
Overall Study
Other
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Lack of Efficacy/ Adverse Event (AE)
|
1
|
1
|
|
Overall Study
AE/ Unsatisfactory Compliance
|
2
|
2
|
|
Overall Study
AE/ Withdrawal
|
1
|
4
|
|
Overall Study
Unsatisfactory Compliance/ Withdrawal
|
1
|
1
|
|
Overall Study
Unsatisfactory Compl./ Lost to Follow up
|
1
|
2
|
|
Overall Study
Withdrawal/ Not specified
|
0
|
1
|
Baseline Characteristics
Prostaglandin E1 in Outpatients With Intermittent Claudication
Baseline characteristics by cohort
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Ethnicity
Caucasian
|
269 participants
n=5 Participants
|
271 participants
n=7 Participants
|
540 participants
n=5 Participants
|
|
Ethnicity
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age categories
>18 - <65
|
108 participants
n=5 Participants
|
100 participants
n=7 Participants
|
208 participants
n=5 Participants
|
|
Age categories
>=65 - <75
|
114 participants
n=5 Participants
|
119 participants
n=7 Participants
|
233 participants
n=5 Participants
|
|
Age categories
>=75
|
47 participants
n=5 Participants
|
53 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Weight
|
77.8 kilogram (kg)
STANDARD_DEVIATION 13.9 • n=5 Participants
|
77.9 kilogram (kg)
STANDARD_DEVIATION 13.5 • n=7 Participants
|
77.9 kilogram (kg)
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Height
|
170.2 centimeter (cm)
STANDARD_DEVIATION 8.6 • n=5 Participants
|
169.3 centimeter (cm)
STANDARD_DEVIATION 8.6 • n=7 Participants
|
169.7 centimeter (cm)
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.77 kilogram/ meter^2 (kg/m^2)
STANDARD_DEVIATION 3.87 • n=5 Participants
|
27.11 kilogram/ meter^2 (kg/m^2)
STANDARD_DEVIATION 3.75 • n=7 Participants
|
26.94 kilogram/ meter^2 (kg/m^2)
STANDARD_DEVIATION 3.81 • n=5 Participants
|
|
Duration of Primary Disease
|
4.9 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
4.3 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
4.6 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)Population: Full Analysis Set (FAS).
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline
|
2.60 meter/meter
Standard Deviation 12.22 • Interval 1.1 to 4.1
|
1.98 meter/meter
Standard Deviation 3.61
|
PRIMARY outcome
Timeframe: From Baseline to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS).
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
|
2.27 meter/meter
Standard Deviation 3.00
|
2.36 meter/meter
Standard Deviation 2.69
|
PRIMARY outcome
Timeframe: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)Population: Full Analysis Set (FAS).
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
|
1.58 meter/meter
Standard Deviation 1.92
|
1.58 meter/meter
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)Population: Full Analysis Set (FAS).
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1
|
1.25 meter/meter
Standard Deviation 0.64
|
1.24 meter/meter
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS).
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1
|
1.54 meter/meter
Standard Deviation 1.53
|
1.57 meter/meter
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS).
The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2
|
1.26 meter/meter
Standard Deviation 0.85
|
1.28 meter/meter
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)Population: Full Analysis Set (FAS).
The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline
|
1.39 meter/meter
Standard Deviation 0.53
|
1.43 meter/meter
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)Population: Full Analysis Set (FAS).
The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline
|
1.64 meter/meter
Standard Deviation 0.86
|
1.76 meter/meter
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)Population: Full Analysis Set (FAS).
The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1
|
1.20 meter/meter
Standard Deviation 0.50
|
1.21 meter/meter
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: From Baseline to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS).
The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline
|
1.89 meter/meter
Standard Deviation 1.40
|
1.99 meter/meter
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS).
The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1
|
1.39 meter/meter
Standard Deviation 0.87
|
1.42 meter/meter
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS).
The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2
|
1.18 meter/meter
Standard Deviation 0.58
|
1.17 meter/meter
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)Population: Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.
Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Pain
|
-0.24 units on a scale
Standard Deviation 0.44
|
-0.27 units on a scale
Standard Deviation 0.49
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Functional status
|
-0.21 units on a scale
Standard Deviation 0.40
|
-0.18 units on a scale
Standard Deviation 0.41
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Anxiety
|
-0.16 units on a scale
Standard Deviation 0.51
|
-0.18 units on a scale
Standard Deviation 0.54
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Mood
|
-0.07 units on a scale
Standard Deviation 0.34
|
-0.08 units on a scale
Standard Deviation 0.37
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Social life
|
-0.05 units on a scale
Standard Deviation 0.34
|
-0.02 units on a scale
Standard Deviation 0.33
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Expectation of treatment
|
-0.00 units on a scale
Standard Deviation 0.42
|
0.01 units on a scale
Standard Deviation 0.42
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
State of general health during the last week
|
-0.51 units on a scale
Standard Deviation 1.48
|
-0.36 units on a scale
Standard Deviation 1.60
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
Quality of life during the last week
|
-0.37 units on a scale
Standard Deviation 1.58
|
-0.38 units on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: From Baseline to the end of 6-months Follow-up (Period 3)Population: Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.
Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline.
Outcome measures
| Measure |
Alprostadil
n=269 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=272 Participants
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Pain
|
-0.28 units on a scale
Standard Deviation 0.57
|
-0.41 units on a scale
Standard Deviation 0.58
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Functional status
|
-0.26 units on a scale
Standard Deviation 0.58
|
-0.35 units on a scale
Standard Deviation 0.57
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Anxiety
|
-0.20 units on a scale
Standard Deviation 0.64
|
-0.22 units on a scale
Standard Deviation 0.66
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Mood
|
-0.06 units on a scale
Standard Deviation 0.48
|
-0.12 units on a scale
Standard Deviation 0.53
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Social life
|
-0.09 units on a scale
Standard Deviation 0.43
|
-0.04 units on a scale
Standard Deviation 0.45
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Expectation of treatment
|
0.07 units on a scale
Standard Deviation 0.51
|
0.11 units on a scale
Standard Deviation 0.49
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
State of general health during the last week
|
-0.43 units on a scale
Standard Deviation 1.83
|
-0.48 units on a scale
Standard Deviation 1.98
|
|
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Quality of life during the last week
|
-0.36 units on a scale
Standard Deviation 2.09
|
-0.39 units on a scale
Standard Deviation 2.20
|
Adverse Events
Alprostadil
Serious events: 19 serious events
Other events: 60 other events
Deaths: 0 deaths
Pentoxifylline
Serious events: 17 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alprostadil
n=276 participants at risk
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=285 participants at risk
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Angina Pectoris
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Cardiac Failure
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Myocardial Infarction
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Cardiac disorders
Tachycardia Paroxysmal
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Oedema Peripheral
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Chest Pain
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Device Related Infection
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Gangrene
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Investigations
Cardiac Enzymes Increased
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Psychiatric disorders
Suicide Attempt
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Reproductive system and breast disorders
Genital Haemorrhage
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
1.4%
4/276 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Haematoma
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Phlebitis
|
0.36%
1/276 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Extremity Necrosis
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.35%
1/285 • Number of events 1 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
Other adverse events
| Measure |
Alprostadil
n=276 participants at risk
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.
|
Pentoxifylline
n=285 participants at risk
4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.4%
4/285 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.8%
5/285 • Number of events 5 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.4%
4/285 • Number of events 5 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
2.1%
6/285 • Number of events 6 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Gastrointestinal disorders
Gastritis
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
3.2%
9/285 • Number of events 10 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.1%
3/285 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Oedema Peripheral
|
1.4%
4/276 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Influenza Like Illness
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.8%
5/285 • Number of events 6 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Infusion Site Irritation
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Infusion Site Swelling
|
1.1%
3/276 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Infusion Site Erythema
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
General disorders
Infusion Site Haematoma
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Nasopharyngitis
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.1%
3/285 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Tooth Infection
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Urinary Tract Infection
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Investigations
Blood Creatinine Increased
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Investigations
Blood Glucose Increased
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Investigations
Transaminases Increased
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.1%
3/285 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.4%
4/285 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
4/276 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Nervous system disorders
Dizziness
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Nervous system disorders
Headache
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Psychiatric disorders
Sleep Disorder
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.72%
2/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Hypertension
|
1.4%
4/276 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
1.4%
4/285 • Number of events 4 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Flushing
|
1.1%
3/276 • Number of events 3 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Phlebitis
|
0.72%
2/276 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.00%
0/285 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/276 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
0.70%
2/285 • Number of events 2 • Adverse Events were collected up to 8 months (246 days) from the 1-week Run-in Period over the 8-weeks Treatment Period (4 weeks Daily Treatment, 4 weeks Interval Treatment) to the end of the 6-months Follow-up Period.
Adverse Events refer to the Safety Set (SS). SS includes all randomized subjects who received at least one dose of trial medication. Subjects did not receive any dose of trial medication in the Run-in Period, so Adverse Events shown here refer to Treatment and Follow-Up Period.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493 (UCB)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60