Trial Outcomes & Findings for Extension in AS: Sustainability of Benefits, Safety and Tolerability (NCT NCT01863732)
NCT ID: NCT01863732
Last Updated: 2019-07-30
Results Overview
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
274 participants
Primary outcome timeframe
Week 104 to Week 260
Results posted on
2019-07-30
Participant Flow
CAIN457F2305 core study consisted of a screening period of 4 Wks before randomization followed by a treatment period of 2 years (Wk 0 through Wk 104). At Wk 104, patients continued into the extension on the same dose of AIN457. If they were on Placebo in the core then randomized to either Group 1 or 2.
Group 1: AIN457 75mg plus placebo 150mg dosed every 4 weeks from Wk 104E1 to Wk 152. At Wk 156 (after unblinding), only AIN457 75mg was dosed or up titrated to AIN457 150mg. Group 2: AIN457 150mg plus placebo 75mg dosed every 4 weeks from Wk 104E1 through Wk 152. At Wk 156 (after unblinding), only secukinumab 150 mg was dosed.
Participant milestones
| Measure |
Secukinumab (AIN457) 75mg Group 1
AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Secukinumab (AIN457) 150mg Group 2
AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
Pbo in Core Then AIN457 75mg Group 1
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Pbo in Core Then AIN457 150mg Group 2
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
87
|
46
|
41
|
|
Overall Study
COMPLETED
|
87
|
75
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
11
|
8
|
Reasons for withdrawal
| Measure |
Secukinumab (AIN457) 75mg Group 1
AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Secukinumab (AIN457) 150mg Group 2
AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
Pbo in Core Then AIN457 75mg Group 1
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Pbo in Core Then AIN457 150mg Group 2
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
3
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Technical problems
|
0
|
1
|
1
|
0
|
|
Overall Study
Subject/guardian decision
|
6
|
9
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Extension in AS: Sustainability of Benefits, Safety and Tolerability
Baseline characteristics by cohort
| Measure |
Secukinumab (AIN457) 75mg Group 1
n=100 Participants
AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Secukinumab (AIN457) 150mg Group 2
n=87 Participants
AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
Pbo in Core Then AIN457 75mg Group 1
n=46 Participants
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Pbo in Core Then AIN457 150mg Group 2
n=41 Participants
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 13.37 • n=99 Participants
|
38.2 years
STANDARD_DEVIATION 11.58 • n=107 Participants
|
43.0 years
STANDARD_DEVIATION 13.00 • n=206 Participants
|
42.5 years
STANDARD_DEVIATION 12.13 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 12.68 • n=31 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
198 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
167 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 104 to Week 260Population: Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.
Outcome measures
| Measure |
Secukinumab (AIN457) 75mg Group 1
n=100 Participants
AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Secukinumab (AIN457) 150mg Group 2
n=87 Participants
AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
Pbo in Core Then AIN457 75mg Group 1
n=46 Participants
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Pbo in Core Then AIN457 150mg Group 2
n=41 Participants
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
|---|---|---|---|---|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 116
|
76.0 % of responders
|
82.1 % of responders
|
76.1 % of responders
|
70.7 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 128
|
70.1 % of responders
|
77.1 % of responders
|
84.8 % of responders
|
75.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 156
|
75.5 % of responders
|
80.2 % of responders
|
76.1 % of responders
|
67.5 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 168
|
74.7 % of responders
|
78.3 % of responders
|
83.3 % of responders
|
78.4 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 244
|
74.7 % of responders
|
82.1 % of responders
|
80.0 % of responders
|
76.5 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 260
|
71.3 % of responders
|
77.6 % of responders
|
81.6 % of responders
|
80.6 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 104
|
71.4 % of responders
|
80.0 % of responders
|
78.6 % of responders
|
73.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 140
|
77.1 % of responders
|
75.0 % of responders
|
75.6 % of responders
|
72.5 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 180
|
81.7 % of responders
|
80.0 % of responders
|
81.0 % of responders
|
78.4 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 192
|
72.3 % of responders
|
84.8 % of responders
|
81.0 % of responders
|
73.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 208
|
73.4 % of responders
|
79.7 % of responders
|
75.0 % of responders
|
78.4 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 220
|
74.4 % of responders
|
81.8 % of responders
|
81.1 % of responders
|
75.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
Week 232
|
76.7 % of responders
|
82.1 % of responders
|
75.7 % of responders
|
77.8 % of responders
|
SECONDARY outcome
Timeframe: Week 104 to Week 260Population: Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group
Outcome measures
| Measure |
Secukinumab (AIN457) 75mg Group 1
n=100 Participants
AIN457 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150 mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Secukinumab (AIN457) 150mg Group 2
n=87 Participants
AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
Pbo in Core Then AIN457 75mg Group 1
n=46 Participants
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 1: secukinumab (AIN457) 75 mg plus placebo to AIN457 150 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), AIN457 75 mg was dosed or uptitration to AIN457 150mg. Secukinumab in PFS for s.c. self-administration Q4W. Participants that up-titrated to AIN457 150 mg were counted only at the originally randomized AIN457 75 mg treatment group.
|
Pbo in Core Then AIN457 150mg Group 2
n=41 Participants
Participants were randomized on Placebo (Pbo) in Core and then re-randomized to Group 2: AIN457 150 mg plus placebo to AIN457 75 mg dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only AIN457 150 mg was dosed. Secukinumab in PFS for s.c. self-administration Q4W.
|
|---|---|---|---|---|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 104
|
53.6 % of responders
|
65.0 % of responders
|
57.1 % of responders
|
48.6 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 116
|
56.3 % of responders
|
59.5 % of responders
|
54.3 % of responders
|
51.2 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 128
|
54.6 % of responders
|
68.7 % of responders
|
58.7 % of responders
|
55.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 140
|
53.1 % of responders
|
60.7 % of responders
|
53.3 % of responders
|
60.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 156
|
50.0 % of responders
|
62.8 % of responders
|
54.3 % of responders
|
55.0 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 168
|
54.7 % of responders
|
67.5 % of responders
|
42.9 % of responders
|
62.2 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 192
|
57.4 % of responders
|
69.6 % of responders
|
52.4 % of responders
|
62.2 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 208
|
52.1 % of responders
|
60.8 % of responders
|
62.5 % of responders
|
56.8 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 220
|
51.1 % of responders
|
67.5 % of responders
|
54.1 % of responders
|
63.9 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 232
|
62.2 % of responders
|
66.7 % of responders
|
59.5 % of responders
|
69.4 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 244
|
60.9 % of responders
|
70.5 % of responders
|
62.9 % of responders
|
61.8 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 260
|
50.6 % of responders
|
64.5 % of responders
|
63.2 % of responders
|
66.7 % of responders
|
|
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
Week 180
|
52.7 % of responders
|
68.8 % of responders
|
52.4 % of responders
|
67.6 % of responders
|
Adverse Events
Any Secukinumab (AIN457) 75 mg
Serious events: 36 serious events
Other events: 126 other events
Deaths: 2 deaths
Any Secukinumab (AIN457) 150 mg
Serious events: 33 serious events
Other events: 157 other events
Deaths: 1 deaths
Placebo
Serious events: 5 serious events
Other events: 45 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Any Secukinumab (AIN457) 75 mg
n=179 participants at risk
Any Secukinumab (AIN457) 75 mg safety in Core Study CAIN457F2305 and this extension study.
|
Any Secukinumab (AIN457) 150 mg
n=263 participants at risk
Any Secukinumab (AIN457) 150 mgsafety in Core Study CAIN457F2305 and this extension study
|
Placebo
n=122 participants at risk
Placebo in Core study CAIN457F2305E1
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Cardiac failure
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
3/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.1%
3/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Eye disorders
Cataract
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Eye disorders
Uveitis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Colitis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.1%
2/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
General disorders
Application site pain
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
General disorders
Chest discomfort
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
General disorders
Pyrexia
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
3/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Appendicitis
|
1.1%
2/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Appendicitis perforated
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Cellulitis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Chronic sinusitis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Helicobacter gastritis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Pneumonia
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Pulmonary tuberculoma
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Pyelonephritis acute
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Respiratory tract infection
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.1%
2/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Investigations
C-reactive protein increased
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
1.1%
2/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.1%
3/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Brain oedema
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.76%
2/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Headache
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Ischaemic stroke
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Migraine
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Stroke in evolution
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Product Issues
Device failure
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Psychiatric disorders
Depression
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Vascular disorders
Peripheral venous disease
|
0.56%
1/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.38%
1/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
Other adverse events
| Measure |
Any Secukinumab (AIN457) 75 mg
n=179 participants at risk
Any Secukinumab (AIN457) 75 mg safety in Core Study CAIN457F2305 and this extension study.
|
Any Secukinumab (AIN457) 150 mg
n=263 participants at risk
Any Secukinumab (AIN457) 150 mgsafety in Core Study CAIN457F2305 and this extension study
|
Placebo
n=122 participants at risk
Placebo in Core study CAIN457F2305E1
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
7.8%
14/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.2%
11/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Eye disorders
Uveitis
|
5.6%
10/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
5.7%
15/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
9/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
3.4%
9/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.5%
26/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
11.0%
29/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
5.7%
7/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.6%
10/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
3.0%
8/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
2.5%
3/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
12/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.6%
12/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Bronchitis
|
5.0%
9/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
6.5%
17/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Gastroenteritis
|
5.6%
10/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
3.8%
10/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Influenza
|
10.6%
19/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
9.9%
26/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Nasopharyngitis
|
25.1%
45/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
24.0%
63/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
7.4%
9/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Pharyngitis
|
7.3%
13/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
9.1%
24/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Rhinitis
|
3.4%
6/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
5.3%
14/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.2%
29/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
8.0%
21/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
10/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.6%
12/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
10.1%
18/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
5.3%
14/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.1%
5/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
6.1%
11/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.9%
13/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
3.3%
4/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
17/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
9.1%
24/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
3.3%
4/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
13/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
7.6%
20/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
9/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.9%
5/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.00%
0/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
9/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
2.7%
7/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Nervous system disorders
Headache
|
14.5%
26/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
10.6%
28/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
5.7%
7/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
12/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
6.8%
18/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
1.6%
2/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
14/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
6.8%
18/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.9%
6/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
|
Vascular disorders
Hypertension
|
7.3%
13/179 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
4.2%
11/263 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
0.82%
1/122 • CAIN457F2305 (Wk 0 to Wk 104)- Cumuilative & Wk 104E1 to Wk 260 for CAIN457F2305E1
Safety includes cumulative data for core \& extension for patients who continued in the extension.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER