Trial Outcomes & Findings for An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults (NCT NCT00615836)
NCT ID: NCT00615836
Last Updated: 2015-12-15
Results Overview
Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
554 participants
Primary outcome timeframe
Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.
Results posted on
2015-12-15
Participant Flow
The study was open only to participants who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II (Day 15) of that study. 799 patients were randomized to treatment in CS29, and 601 patients formed the intent-to-treat population in CS29. This population was used to assess durability of effect in CS31.
Participants were initially assigned in a blinded manner to the same treatment dose received in Study CS29. After CS29 database lock, CS31 was unblinded, and based on the results of CS29, participants assigned to 10 μg were randomly assigned at their next scheduled visit to 25 μg, 50 μg, or 100 μg of desmopressin Melt.
Participant milestones
| Measure |
Desmopressin Melt 10 μg
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.
During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
|
Desmopressin Melt 50 μg
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
|
Placebo
Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
|
|---|---|---|---|---|---|
|
Part I of Core Study (FE992026 CS29)
STARTED
|
163
|
158
|
158
|
160
|
160
|
|
Part I of Core Study (FE992026 CS29)
Intent-to-treat Population
|
155
|
152
|
148
|
146
|
156
|
|
Part I of Core Study (FE992026 CS29)
COMPLETED
|
144
|
148
|
138
|
135
|
145
|
|
Part I of Core Study (FE992026 CS29)
NOT COMPLETED
|
19
|
10
|
20
|
25
|
15
|
|
Extension Study (FE992026 CS31)
STARTED
|
141
|
144
|
132
|
137
|
0
|
|
Extension Study (FE992026 CS31)
COMPLETED
|
0
|
58
|
59
|
53
|
0
|
|
Extension Study (FE992026 CS31)
NOT COMPLETED
|
141
|
86
|
73
|
84
|
0
|
Reasons for withdrawal
| Measure |
Desmopressin Melt 10 μg
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.
During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
|
Desmopressin Melt 50 μg
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
|
Placebo
Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
|
|---|---|---|---|---|---|
|
Extension Study (FE992026 CS31)
Adverse Event
|
7
|
12
|
15
|
13
|
0
|
|
Extension Study (FE992026 CS31)
Serum sodium ≤125 mmol/L
|
1
|
0
|
3
|
3
|
0
|
|
Extension Study (FE992026 CS31)
Use of exclusionary medication
|
1
|
2
|
1
|
0
|
0
|
|
Extension Study (FE992026 CS31)
Protocol Violation
|
4
|
5
|
2
|
3
|
0
|
|
Extension Study (FE992026 CS31)
Withdrawal by Subject
|
37
|
42
|
38
|
43
|
0
|
|
Extension Study (FE992026 CS31)
Lost to Follow-up
|
10
|
14
|
5
|
10
|
0
|
|
Extension Study (FE992026 CS31)
Other
|
10
|
7
|
8
|
8
|
0
|
|
Extension Study (FE992026 CS31)
Not reported
|
6
|
4
|
1
|
4
|
0
|
|
Extension Study (FE992026 CS31)
Re-randomized to a higher dose
|
65
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Baseline characteristics by cohort
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 14.41 • n=93 Participants
|
62.4 years
STANDARD_DEVIATION 13.22 • n=4 Participants
|
61.6 years
STANDARD_DEVIATION 11.80 • n=27 Participants
|
62.1 years
STANDARD_DEVIATION 12.34 • n=483 Participants
|
61.9 years
STANDARD_DEVIATION 12.97 • n=36 Participants
|
|
Age, Customized
<65 years
|
80 participants
n=93 Participants
|
65 participants
n=4 Participants
|
71 participants
n=27 Participants
|
66 participants
n=483 Participants
|
282 participants
n=36 Participants
|
|
Age, Customized
>=65 years
|
75 participants
n=93 Participants
|
87 participants
n=4 Participants
|
77 participants
n=27 Participants
|
80 participants
n=483 Participants
|
319 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
275 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
326 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
123 participants
n=93 Participants
|
120 participants
n=4 Participants
|
119 participants
n=27 Participants
|
111 participants
n=483 Participants
|
473 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
21 participants
n=93 Participants
|
28 participants
n=4 Participants
|
24 participants
n=27 Participants
|
27 participants
n=483 Participants
|
100 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
6 participants
n=483 Participants
|
13 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/other Pacific Islander
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
2 participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
11 participants
n=36 Participants
|
|
Ethnic Origin
Hispanic
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
13 participants
n=27 Participants
|
6 participants
n=483 Participants
|
39 participants
n=36 Participants
|
|
Ethnic Origin
Not Hispanic
|
145 participants
n=93 Participants
|
142 participants
n=4 Participants
|
135 participants
n=27 Participants
|
140 participants
n=483 Participants
|
562 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in Mean Number of Nocturnal Voids
8 Weeks [N=103, 96, 92, 104]
|
-1.12 nocturnal voids
Standard Deviation 1.166
|
-1.30 nocturnal voids
Standard Deviation 1.180
|
-1.42 nocturnal voids
Standard Deviation 1.278
|
-1.47 nocturnal voids
Standard Deviation 1.080
|
—
|
|
Change From Baseline in Mean Number of Nocturnal Voids
12 Weeks [N=85, 81, 77, 81]
|
-1.15 nocturnal voids
Standard Deviation 1.151
|
-1.40 nocturnal voids
Standard Deviation 1.249
|
-1.48 nocturnal voids
Standard Deviation 1.155
|
-1.73 nocturnal voids
Standard Deviation 1.040
|
—
|
|
Change From Baseline in Mean Number of Nocturnal Voids
20 Weeks [N=62, 58, 64, 64]
|
-1.25 nocturnal voids
Standard Deviation 1.167
|
-1.61 nocturnal voids
Standard Deviation 1.175
|
-1.69 nocturnal voids
Standard Deviation 1.167
|
-1.86 nocturnal voids
Standard Deviation 1.082
|
—
|
|
Change From Baseline in Mean Number of Nocturnal Voids
28 Weeks [N=63, 85, 62, 62]
|
-1.47 nocturnal voids
Standard Deviation 1.389
|
-1.36 nocturnal voids
Standard Deviation 1.141
|
-1.49 nocturnal voids
Standard Deviation 1.276
|
-1.81 nocturnal voids
Standard Deviation 0.903
|
—
|
|
Change From Baseline in Mean Number of Nocturnal Voids
52-56 Weeks [N=45, 91, 81, 77]
|
-1.79 nocturnal voids
Standard Deviation 1.291
|
-1.40 nocturnal voids
Standard Deviation 1.224
|
-1.78 nocturnal voids
Standard Deviation 1.342
|
-2.14 nocturnal voids
Standard Deviation 1.109
|
—
|
|
Change From Baseline in Mean Number of Nocturnal Voids
72-76 Weeks [N=0, 79, 72, 67]
|
NA nocturnal voids
Standard Deviation NA
No participants remained in this treatment group.
|
-1.51 nocturnal voids
Standard Deviation 1.253
|
-1.86 nocturnal voids
Standard Deviation 1.345
|
-2.24 nocturnal voids
Standard Deviation 1.287
|
—
|
|
Change From Baseline in Mean Number of Nocturnal Voids
92-96 Weeks [N=0, 68, 62, 62]
|
NA nocturnal voids
Standard Deviation NA
No participants remained in this treatment group.
|
-1.39 nocturnal voids
Standard Deviation 1.180
|
-1.91 nocturnal voids
Standard Deviation 1.359
|
-2.09 nocturnal voids
Standard Deviation 1.219
|
—
|
PRIMARY outcome
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
Percentage of participants with \>33% reduction from Baseline in the mean number of nocturnal urinations per night, calculated from the 3-day voiding diary completed prior to each study visit. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
92-96 Weeks [N=0, 68, 62, 62]
|
NA percentage of participants
No participants remained in this treatment group.
|
63.2 percentage of participants
|
77.4 percentage of participants
|
88.7 percentage of participants
|
—
|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
8 Weeks [N=103, 96, 92, 104]
|
57.3 percentage of participants
|
63.5 percentage of participants
|
67.4 percentage of participants
|
68.3 percentage of participants
|
—
|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
12 Weeks [N=85, 81, 77, 81]
|
60.0 percentage of participants
|
67.9 percentage of participants
|
70.1 percentage of participants
|
81.5 percentage of participants
|
—
|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
20 Weeks [N=62, 58, 64, 64]
|
56.5 percentage of participants
|
79.3 percentage of participants
|
76.6 percentage of participants
|
82.8 percentage of participants
|
—
|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
28 Weeks [N=63, 85, 62, 62]
|
63.5 percentage of participants
|
65.9 percentage of participants
|
74.2 percentage of participants
|
87.1 percentage of participants
|
—
|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
52-56 Weeks [N=45, 91, 81, 77]
|
75.6 percentage of participants
|
73.6 percentage of participants
|
71.6 percentage of participants
|
88.3 percentage of participants
|
—
|
|
Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids
72-76 Weeks [N=0, 79, 72, 67]
|
NA percentage of participants
No participants remained in this treatment group.
|
69.6 percentage of participants
|
77.8 percentage of participants
|
86.6 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the initial period of undisturbed sleep was calculated and averaged for the 3 days. The Initial Period of Undisturbed Sleep is the time elapsed from bedtime to either first void or morning arising minus the minutes it took to fall asleep. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in Initial Period of Undisturbed Sleep
8 Weeks [N=93, 82, 83, 90]
|
77.64 minutes
Standard Deviation 118.822
|
96.58 minutes
Standard Deviation 112.750
|
104.72 minutes
Standard Deviation 120.236
|
126.63 minutes
Standard Deviation 114.501
|
—
|
|
Change From Baseline in Initial Period of Undisturbed Sleep
12 Weeks [N=78, 69, 66, 72]
|
97.57 minutes
Standard Deviation 116.855
|
116.70 minutes
Standard Deviation 110.738
|
118.71 minutes
Standard Deviation 112.450
|
144.77 minutes
Standard Deviation 116.376
|
—
|
|
Change From Baseline in Initial Period of Undisturbed Sleep
20 Weeks [N=55, 51, 59, 58]
|
94.51 minutes
Standard Deviation 113.892
|
115.60 minutes
Standard Deviation 105.136
|
133.66 minutes
Standard Deviation 151.510
|
155.44 minutes
Standard Deviation 119.185
|
—
|
|
Change From Baseline in Initial Period of Undisturbed Sleep
28 Weeks [N=59, 80, 58, 61]
|
113.60 minutes
Standard Deviation 122.291
|
116.46 minutes
Standard Deviation 114.475
|
101.04 minutes
Standard Deviation 121.681
|
143.86 minutes
Standard Deviation 114.170
|
—
|
|
Change From Baseline in Initial Period of Undisturbed Sleep
52-56 Weeks [N=42, 88, 75, 71]
|
120.91 minutes
Standard Deviation 134.943
|
110.59 minutes
Standard Deviation 113.658
|
121.34 minutes
Standard Deviation 129.149
|
167.72 minutes
Standard Deviation 118.301
|
—
|
|
Change From Baseline in Initial Period of Undisturbed Sleep
72-76 Weeks [N=0, 77, 68, 60]
|
NA minutes
Standard Deviation NA
No participants remained in this treatment group.
|
125.21 minutes
Standard Deviation 134.963
|
137.91 minutes
Standard Deviation 136.870
|
200.67 minutes
Standard Deviation 137.206
|
—
|
|
Change From Baseline in Initial Period of Undisturbed Sleep
92-96 Weeks [N=0, 66, 56, 57]
|
NA minutes
Standard Deviation NA
No participants remained in this treatment group.
|
134.14 minutes
Standard Deviation 172.834
|
163.31 minutes
Standard Deviation 124.169
|
185.74 minutes
Standard Deviation 118.865
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96.Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
Participants completed a sleep diary on 3 consecutive mornings prior to each study visit, from which the total sleep time was calculated and averaged for the 3 days. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in Total Sleep Time
8 Weeks [N=103, 96, 91, 104]
|
13.93 minutes
Standard Deviation 65.628
|
19.77 minutes
Standard Deviation 71.609
|
33.17 minutes
Standard Deviation 77.892
|
14.68 minutes
Standard Deviation 76.679
|
—
|
|
Change From Baseline in Total Sleep Time
52-56 Weeks [N=46, 91, 80, 77]
|
21.09 minutes
Standard Deviation 65.705
|
20.86 minutes
Standard Deviation 71.695
|
25.68 minutes
Standard Deviation 95.625
|
15.84 minutes
Standard Deviation 77.880
|
—
|
|
Change From Baseline in Total Sleep Time
12 Weeks [N=85, 81, 77, 81]
|
20.66 minutes
Standard Deviation 65.419
|
24.94 minutes
Standard Deviation 65.785
|
30.34 minutes
Standard Deviation 68.221
|
12.90 minutes
Standard Deviation 73.777
|
—
|
|
Change From Baseline in Total Sleep Time
20 Weeks [N=61, 58, 64, 64]
|
12.64 minutes
Standard Deviation 63.952
|
36.13 minutes
Standard Deviation 67.708
|
34.01 minutes
Standard Deviation 93.074
|
24.54 minutes
Standard Deviation 75.385
|
—
|
|
Change From Baseline in Total Sleep Time
28 Weeks [N=64, 85, 62, 62]
|
11.12 minutes
Standard Deviation 62.382
|
34.99 minutes
Standard Deviation 65.342
|
33.99 minutes
Standard Deviation 74.539
|
22.25 minutes
Standard Deviation 69.033
|
—
|
|
Change From Baseline in Total Sleep Time
72-76 Weeks [N=0, 80, 72, 66]
|
NA minutes
Standard Deviation NA
No participants remained in this treatment group.
|
26.44 minutes
Standard Deviation 70.467
|
33.22 minutes
Standard Deviation 78.286
|
19.34 minutes
Standard Deviation 92.171
|
—
|
|
Change From Baseline in Total Sleep Time
92-96 Weeks [N=0, 67, 61, 62]
|
NA minutes
Standard Deviation NA
No participants remained in this treatment group.
|
23.45 minutes
Standard Deviation 65.624
|
37.33 minutes
Standard Deviation 82.320
|
26.83 minutes
Standard Deviation 95.183
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. To assess nighttime urination bother, participants were asked to rate the degree of bother of nighttime urination by answering the question "Night time urination: How much does this bother you?" on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate greater bother. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
Week 16 [N=34, 42, 44, 35]
|
-3.68 units on a scale
Standard Deviation 3.409
|
-2.62 units on a scale
Standard Deviation 3.695
|
-3.77 units on a scale
Standard Deviation 3.436
|
-3.71 units on a scale
Standard Deviation 3.295
|
—
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
Visit 12 [N=0, 84, 77, 67]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
-2.83 units on a scale
Standard Deviation 3.488
|
-3.77 units on a scale
Standard Deviation 3.211
|
-4.12 units on a scale
Standard Deviation 3.240
|
—
|
|
Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score
End of Study [N=17, 93, 84, 82]
|
-3.12 units on a scale
Standard Deviation 2.934
|
-2.96 units on a scale
Standard Deviation 3.668
|
-3.46 units on a scale
Standard Deviation 3.504
|
-3.62 units on a scale
Standard Deviation 3.512
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question (which is not included in the overall score). The 12 core items are scored on a 0 to 4 scale, and the overall score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
Week 16 [N=34, 42, 44, 35]
|
20.16 units on a scale
Standard Deviation 29.515
|
22.42 units on a scale
Standard Deviation 18.752
|
22.06 units on a scale
Standard Deviation 21.985
|
26.13 units on a scale
Standard Deviation 22.728
|
—
|
|
Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
Visit 12 [N=0, 84, 77, 66]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
19.37 units on a scale
Standard Deviation 19.362
|
21.51 units on a scale
Standard Deviation 22.838
|
19.89 units on a scale
Standard Deviation 19.684
|
—
|
|
Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score
End of Study [N=17, 94, 85, 80]
|
12.87 units on a scale
Standard Deviation 16.913
|
17.46 units on a scale
Standard Deviation 20.497
|
19.13 units on a scale
Standard Deviation 23.393
|
18.36 units on a scale
Standard Deviation 19.684
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The bother/concern domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in NQoL Bother/Concern Domain Score
Week 16 [N=34, 42, 44, 35]
|
22.43 units on a scale
Standard Deviation 28.977
|
22.82 units on a scale
Standard Deviation 20.083
|
23.30 units on a scale
Standard Deviation 26.783
|
28.81 units on a scale
Standard Deviation 27.010
|
—
|
|
Change From Baseline in NQoL Bother/Concern Domain Score
Visit 12 [N=0, 83, 77, 66]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
18.27 units on a scale
Standard Deviation 21.979
|
19.70 units on a scale
Standard Deviation 23.702
|
17.11 units on a scale
Standard Deviation 21.658
|
—
|
|
Change From Baseline in NQoL Bother/Concern Domain Score
End of Study [N=17, 94, 84, 80]
|
13.73 units on a scale
Standard Deviation 23.047
|
14.23 units on a scale
Standard Deviation 20.589
|
16.47 units on a scale
Standard Deviation 25.871
|
16.25 units on a scale
Standard Deviation 21.335
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The 12 core items are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. The sleep/energy domain summary score is calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
Week 16 [N=34, 42, 44, 35]
|
17.89 units on a scale
Standard Deviation 34.152
|
22.02 units on a scale
Standard Deviation 20.645
|
20.83 units on a scale
Standard Deviation 20.333
|
23.45 units on a scale
Standard Deviation 21.534
|
—
|
|
Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
Visit 12 [N=0, 85, 77, 66]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
20.20 units on a scale
Standard Deviation 21.046
|
23.32 units on a scale
Standard Deviation 25.311
|
22.66 units on a scale
Standard Deviation 20.829
|
—
|
|
Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score
End of Study [N=17, 93, 84, 81]
|
12.01 units on a scale
Standard Deviation 18.510
|
20.30 units on a scale
Standard Deviation 25.070
|
21.83 units on a scale
Standard Deviation 23.884
|
20.58 units on a scale
Standard Deviation 22.208
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The NQoL is a self-administered 13-item questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The global QoL question is scored on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate better impact on quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
Visit 12 [N=0, 85, 77, 69]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
0.38 units on a scale
Standard Deviation 1.112
|
0.48 units on a scale
Standard Deviation 0.788
|
0.46 units on a scale
Standard Deviation 0.867
|
—
|
|
Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
End of Study [N=17, 93, 85, 81]
|
0.18 units on a scale
Standard Deviation 0.529
|
0.34 units on a scale
Standard Deviation 0.801
|
0.47 units on a scale
Standard Deviation 0.933
|
0.43 units on a scale
Standard Deviation 0.851
|
—
|
|
Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score
Week 16 [N=34, 42, 44, 35]
|
0.29 units on a scale
Standard Deviation 0.799
|
0.36 units on a scale
Standard Deviation 0.932
|
0.68 units on a scale
Standard Deviation 0.708
|
0.26 units on a scale
Standard Deviation 0.701
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The 19 individual items are scored on an evenly weighted 0 to 3 scale and generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these 7 components yields 1 global score ranging from 0 to 21. Higher numbers indicate greater sleep disturbance. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
Visit 12 [N=0, 80, 73, 65]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
-1.59 units on a scale
Standard Deviation 3.546
|
-2.99 units on a scale
Standard Deviation 3.747
|
-2.66 units on a scale
Standard Deviation 3.374
|
—
|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
Week 16 [N=32, 39, 42, 34]
|
-2.41 units on a scale
Standard Deviation 3.555
|
-2.59 units on a scale
Standard Deviation 3.507
|
-3.52 units on a scale
Standard Deviation 3.556
|
-2.94 units on a scale
Standard Deviation 3.084
|
—
|
|
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
End of Study [N=16, 89, 78, 78]
|
-1.69 units on a scale
Standard Deviation 2.387
|
-2.12 units on a scale
Standard Deviation 3.680
|
-2.88 units on a scale
Standard Deviation 4.212
|
-1.54 units on a scale
Standard Deviation 3.617
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Mental Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
End of Study [N=17, 91, 81, 80]
|
-0.49 units on a scale
Standard Deviation 8.426
|
3.15 units on a scale
Standard Deviation 9.929
|
1.77 units on a scale
Standard Deviation 12.017
|
1.30 units on a scale
Standard Deviation 9.954
|
—
|
|
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
Week 16 [N=34, 42, 44, 34]
|
5.82 units on a scale
Standard Deviation 7.784
|
3.84 units on a scale
Standard Deviation 9.101
|
1.57 units on a scale
Standard Deviation 8.910
|
4.14 units on a scale
Standard Deviation 8.590
|
—
|
|
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score
Visit 12 [N=0, 82, 73, 66]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
0.53 units on a scale
Standard Deviation 8.167
|
1.39 units on a scale
Standard Deviation 11.163
|
0.14 units on a scale
Standard Deviation 8.858
|
—
|
SECONDARY outcome
Timeframe: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months)Population: Efficacy Analysis dataset = CS29 ITT population (all randomized patients who received \>=1 dose of study drug and provided \>=1 primary efficacy measure during Part I) who were on active treatment. # analyzed represents baseline participants. N= indicates # of participants for whom data were also available at the post-baseline time point.
The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions spanning 8 domains: physical functioning, role function-physical, role function-emotional, bodily pain, general health, vitality, social functioning, and mental health. These scales are combined to create 2 summary measures: the Physical Health Summary and Mental Health Summary. The Physical Health Summary score ranges from 0 to 100, where higher numbers indicate better quality of life. Participants in the 10μg arm are included only until the time of dose escalation.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=155 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=152 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=148 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=146 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
Visit 12 [N=0, 82, 73, 66]
|
NA units on a scale
Standard Deviation NA
No participants remained in this treatment group.
|
1.35 units on a scale
Standard Deviation 8.170
|
2.08 units on a scale
Standard Deviation 8.879
|
2.28 units on a scale
Standard Deviation 7.222
|
—
|
|
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
Week 16 [N=34, 42, 44, 34]
|
1.23 units on a scale
Standard Deviation 7.387
|
1.42 units on a scale
Standard Deviation 7.444
|
2.62 units on a scale
Standard Deviation 6.934
|
0.14 units on a scale
Standard Deviation 8.900
|
—
|
|
Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score
End of Study [N=17, 91, 81, 80]
|
1.29 units on a scale
Standard Deviation 4.077
|
-0.02 units on a scale
Standard Deviation 7.274
|
1.75 units on a scale
Standard Deviation 8.794
|
-0.67 units on a scale
Standard Deviation 9.923
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months).Population: Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure; therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
An AE was any untoward medical occurrence that did not necessarily have a causal relationship with the study drug. An adverse drug reaction (ADR) was an AE evaluated by the Investigator as being probably or possibly causally related to treatment with the study drug. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event that could have jeopardized the patient's safety or required medical or surgical intervention to prevent 1 of the outcomes listed above. The intensity of an AE was defined as severe if it resulted in the inability to work or perform usual activities.
Outcome measures
| Measure |
Desmopressin Melt 10 μg
n=160 Participants
Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=195 Participants
Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 50 μg
n=227 Participants
Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=217 Participants
Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
|
Desmopressin Melt 100 μg
n=224 Participants
Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (AEs)
All adverse events
|
81 participants
|
149 participants
|
188 participants
|
187 participants
|
190 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Deaths
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Serious adverse events
|
1 participants
|
9 participants
|
22 participants
|
29 participants
|
21 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
AEs leading to discontinuation
|
7 participants
|
14 participants
|
20 participants
|
33 participants
|
31 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Severe adverse events
|
2 participants
|
21 participants
|
36 participants
|
39 participants
|
25 participants
|
|
Participants With Treatment-Emergent Adverse Events (AEs)
Adverse drug reactions (ADRs)
|
52 participants
|
88 participants
|
87 participants
|
100 participants
|
107 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 64 other events
Deaths: 0 deaths
Desmopressin Melt 10 μg
Serious events: 9 serious events
Other events: 113 other events
Deaths: 0 deaths
Desmopressin Melt 25 μg
Serious events: 22 serious events
Other events: 147 other events
Deaths: 0 deaths
Desmopressin Melt 50 μg
Serious events: 29 serious events
Other events: 154 other events
Deaths: 0 deaths
Desmopressin Melt 100 μg
Serious events: 21 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=160 participants at risk
Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
|
Desmopressin Melt 10 μg
n=195 participants at risk
Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=227 participants at risk
Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
Desmopressin Melt 50 μg
n=217 participants at risk
Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
Desmopressin Melt 100 μg
n=224 participants at risk
Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.4%
3/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.8%
4/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Cardiac disorders
Left Ventricular Hypertrophy
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.92%
2/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.89%
2/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
General disorders
Asthenia
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Scapula Fracture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Shunt Malfunction
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Investigations
Weight Decreased
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.1%
1/93 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/101 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/131 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/118 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.84%
1/119 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous Cell Lung Cancer
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric Cancer
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Syncope
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Coordination Abnormal
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Psychiatric disorders
Depression
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/93 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/101 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.76%
1/131 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/118 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.84%
1/119 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.45%
1/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Respiratory, thoracic and mediastinal disorders
Haemopneumothorax
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Aneurysm Ruptured
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.44%
1/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Hypertension
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.46%
1/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.00%
0/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
Other adverse events
| Measure |
Placebo
n=160 participants at risk
Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
|
Desmopressin Melt 10 μg
n=195 participants at risk
Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
|
Desmopressin Melt 25 μg
n=227 participants at risk
Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
Desmopressin Melt 50 μg
n=217 participants at risk
Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
Desmopressin Melt 100 μg
n=224 participants at risk
Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
27.5%
44/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
35.9%
70/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
27.3%
62/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
29.5%
64/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
27.2%
61/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Headache
|
5.6%
9/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
8.7%
17/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
7.5%
17/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
8.8%
19/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
11.2%
25/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.2%
2/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.2%
12/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
9.7%
22/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
8.8%
19/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
11.6%
26/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Vascular disorders
Hypertension
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.1%
8/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
9.3%
21/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.9%
15/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.2%
14/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
3/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.1%
10/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
7.9%
18/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.9%
15/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
8.9%
20/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.6%
7/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.6%
15/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
9.2%
20/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.9%
11/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Urinary Tract Infection
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.1%
10/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
8.4%
19/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.9%
15/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.7%
15/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.1%
10/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.7%
13/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.9%
15/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
7.1%
16/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.2%
12/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.2%
14/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.9%
15/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.1%
7/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.5%
3/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
2.2%
5/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.9%
15/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.7%
15/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
2.6%
5/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.7%
13/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.5%
12/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.8%
13/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
General disorders
Fatigue
|
1.2%
2/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.7%
13/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.8%
4/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.7%
8/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.1%
7/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Psychiatric disorders
Insomnia
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.1%
8/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.1%
7/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
6.0%
13/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.8%
13/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Sinusitis
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.6%
9/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.7%
13/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.6%
10/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.0%
9/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.51%
1/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.5%
8/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.5%
12/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.4%
12/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.5%
3/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.3%
12/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.8%
4/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.9%
11/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Nervous system disorders
Dizziness
|
0.62%
1/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.6%
9/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.4%
10/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.1%
11/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.9%
11/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
Infections and infestations
Influenza
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
1.5%
3/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.5%
8/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.1%
11/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.1%
7/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/160 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
3.1%
6/195 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
0.88%
2/227 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
5.1%
11/217 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
4.5%
10/224 • From first dose of study drug in Study CS29 until the end of Study CS31 (up to 35 months).
Safety dataset included all patients who received at least 1 dose of study drug in either Study CS29 or CS31 and counted patients according to their study drug exposure, therefore patients could be included in more than 1 treatment arm. Of the 1023 patients, 799 were unique patients enrolled in CS29, 222 were re-randomized and 2 had dose decreased.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER