Trial Outcomes & Findings for 24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis (NCT NCT01989468)
NCT ID: NCT01989468
Last Updated: 2019-04-16
Results Overview
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
414 participants
Primary outcome timeframe
Week 24
Results posted on
2019-04-16
Participant Flow
Patients were randomized to 1 of 3 treatment arms (1:1:1) and planned to be treated for 156 weeks. Placebo non-responders had the option to be re-randomized at Week 16 and placebo responders had the option to be re-randomized at Week 24. Thus, of the 137 original placebo patients 64 were re-randomized to AIN457 150 mg and 65 to AIN457 300 mg.
A screening period (SCR) running up to 10 weeks before randomization was used to assess eligibility.
Participant milestones
| Measure |
AIN457 150 mg
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo_AIN457 150 mg
Placebo switch to Secukinumab/AIN457 150 mg
|
Placebo_AIN457 300 mg
Placebo switch to Secukinumab/AIN457 300 mg
|
Placebo Not Rerandomized
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
138
|
139
|
64
|
65
|
8
|
|
Overall Study
COMPLETED
|
91
|
102
|
45
|
49
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
37
|
19
|
16
|
8
|
Reasons for withdrawal
| Measure |
AIN457 150 mg
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo_AIN457 150 mg
Placebo switch to Secukinumab/AIN457 150 mg
|
Placebo_AIN457 300 mg
Placebo switch to Secukinumab/AIN457 300 mg
|
Placebo Not Rerandomized
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
15
|
4
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
11
|
11
|
7
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
4
|
1
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Technical Problems
|
3
|
1
|
3
|
1
|
0
|
|
Overall Study
Subject Guardian Decision
|
11
|
6
|
4
|
4
|
1
|
|
Overall Study
Death
|
3
|
0
|
1
|
0
|
0
|
Baseline Characteristics
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
AIN457 150 mg
n=138 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=139 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
367 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
129 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Outcome measures
| Measure |
AIN457 150 mg
n=138 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=139 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24
|
58 Participants
|
67 Participants
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]
Outcome measures
| Measure |
AIN457 150 mg
n=138 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=139 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24
|
26 Participants
|
48 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count \[proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)\], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP \< 2.6 is interpreted as remission.
Outcome measures
| Measure |
AIN457 150 mg
n=138 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=139 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24
|
-1.24 Unit on a scale
Standard Error 0.095
|
-1.56 Unit on a scale
Standard Error 0.093
|
-0.64 Unit on a scale
Standard Error 0.127
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
Outcome measures
| Measure |
AIN457 150 mg
n=68 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=62 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=59 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24
|
34 Participants
|
29 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Outcome measures
| Measure |
AIN457 150 mg
n=138 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=139 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24
Mental Component Summary (MCS)
|
1.68 Unit on a scale
Standard Error 0.837
|
4.41 Unit on a scale
Standard Error 0.822
|
-0.10 Unit on a scale
Standard Error 1.142
|
—
|
|
Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24
Physical Component Summary (PCS)
|
3.42 Unit on a scale
Standard Error 0.600
|
6.46 Unit on a scale
Standard Error 0.590
|
2.94 Unit on a scale
Standard Error 0.830
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
Outcome measures
| Measure |
AIN457 150 mg
n=68 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=62 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=59 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24
|
25 Participants
|
21 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.
The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=138 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=139 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24
|
-0.27 Unit on a scale
Standard Error 0.043
|
-0.38 Unit on a scale
Standard Error 0.042
|
-0.17 Unit on a scale
Standard Error 0.055
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Dactylitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.
The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.
Outcome measures
| Measure |
AIN457 150 mg
n=36 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=46 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=36 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline
|
22 Participants
|
24 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The Enthesitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.
The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
Outcome measures
| Measure |
AIN457 150 mg
n=95 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=88 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=98 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline
|
60 Participants
|
53 Participants
|
83 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to last study visit, up to 3 yearsPopulation: Safety Set, based on Final Analysis. All subjects who took at least one dose of study treatment during the treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.
Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).
Outcome measures
| Measure |
AIN457 150 mg
n=202 Participants
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
AIN457 300 mg
n=284 Participants
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=406 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Placebo
n=137 Participants
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)
SAEs by Primary System Organ Class (SOC)
|
42 Participants
|
35 Participants
|
76 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)
AEs by Primary System Organ Class (SOC)
|
176 Participants
|
230 Participants
|
363 Participants
|
81 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)
Deaths by Primary System Organ Class (SOC)
|
4 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Any AIN457 150 mg
Serious events: 42 serious events
Other events: 153 other events
Deaths: 4 deaths
Any AIN457 300 mg
Serious events: 35 serious events
Other events: 201 other events
Deaths: 0 deaths
Any AIN457
Serious events: 76 serious events
Other events: 320 other events
Deaths: 4 deaths
Placebo
Serious events: 9 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Any AIN457 150 mg
n=202 participants at risk
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Any AIN457 300 mg
n=284 participants at risk
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Any AIN457
n=406 participants at risk
Any patients exposed to AIN457
|
Placebo
n=137 participants at risk
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Angina pectoris
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Cardiogenic shock
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
0.99%
2/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Eye disorders
Cataract
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Eye disorders
Retinal detachment
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Gastritis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
General disorders
Asthenia
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
General disorders
Non-cardiac chest pain
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Abscess of salivary gland
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Bronchitis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Cellulitis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Device related infection
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Enterococcal sepsis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Erysipelas
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Joint abscess
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Pneumonia
|
1.5%
3/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.99%
4/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Staphylococcal infection
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
2/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Wound infection
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Cardiac valve rupture
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Investigations
Weight decreased
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.99%
2/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.99%
2/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.4%
4/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
6/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive papillary breast carcinoma
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage IV
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Aphasia
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Coma
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Headache
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Hemiplegia
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Ischaemic stroke
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Lacunar infarction
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Quadriparesis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Syncope
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Product Issues
Device dislocation
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Product Issues
Device loosening
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Psychiatric disorders
Depression
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Psychiatric disorders
Sopor
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Psychiatric disorders
Suicidal ideation
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.49%
2/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Reproductive system and breast disorders
Cystocele
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Reproductive system and breast disorders
Rectocele
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Vascular disorders
Circulatory collapse
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.35%
1/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Vascular disorders
Varicose vein
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.25%
1/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
Other adverse events
| Measure |
Any AIN457 150 mg
n=202 participants at risk
1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Any AIN457 300 mg
n=284 participants at risk
2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
Any AIN457
n=406 participants at risk
Any patients exposed to AIN457
|
Placebo
n=137 participants at risk
Matching Placebo at Beseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.1%
3/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
9/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Cardiac disorders
Palpitations
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.4%
4/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
9/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.8%
8/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.0%
12/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
10/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.2%
9/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.2%
17/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
2/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.7%
11/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
20/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.7%
19/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
9.6%
39/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
2/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.0%
12/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.0%
8/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
12/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.3%
18/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
7.4%
30/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.1%
7/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.1%
3/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.9%
4/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
General disorders
Fatigue
|
7.9%
16/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.5%
10/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.4%
26/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
2/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
General disorders
Injection site erythema
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.74%
3/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
General disorders
Non-cardiac chest pain
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
General disorders
Oedema peripheral
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Bronchitis
|
5.4%
11/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
8.1%
23/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
8.4%
34/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.4%
6/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Conjunctivitis
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.2%
9/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.2%
13/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Cystitis
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.8%
5/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.7%
11/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Ear infection
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
10/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.5%
10/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.9%
20/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Influenza
|
5.9%
12/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.6%
16/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.4%
26/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.4%
4/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.5%
10/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Nasopharyngitis
|
21.8%
44/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
22.2%
63/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
25.9%
105/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
11.7%
16/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Oral candidiasis
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.7%
11/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Oral herpes
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.8%
8/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.0%
12/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Otitis media
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
6/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Pharyngitis
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.8%
8/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.0%
12/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.6%
13/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.4%
18/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.8%
5/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.2%
5/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Rhinitis
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.5%
7/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.0%
12/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Sinusitis
|
5.0%
10/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.2%
12/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.4%
22/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.9%
4/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Tonsillitis
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.9%
14/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.4%
18/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.4%
27/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
12.3%
35/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
15.0%
61/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.1%
7/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
13/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
7.0%
20/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
7.6%
31/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
2/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.4%
4/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
9/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.9%
11/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.7%
15/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.0%
8/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.5%
10/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
5.4%
11/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.2%
17/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
8/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.1%
3/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.7%
11/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.0%
6/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.1%
3/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
9/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
17/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
8.1%
23/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
9.9%
40/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.5%
7/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.0%
8/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
17/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
8.5%
24/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
10.1%
41/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.4%
4/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
9/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
6/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.99%
2/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.99%
4/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.9%
14/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.4%
14/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.8%
5/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.5%
10/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
9.9%
20/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
7.4%
21/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
10.1%
41/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
3.6%
5/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Dizziness
|
3.5%
7/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.1%
3/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.5%
10/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
2/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Headache
|
8.9%
18/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.3%
18/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
8.9%
36/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.1%
7/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Nervous system disorders
Sciatica
|
2.0%
4/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.8%
5/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
9/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Psychiatric disorders
Depression
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.1%
3/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.0%
8/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.4%
4/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.99%
4/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
17/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.2%
12/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
7.1%
29/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
4.4%
6/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
10/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.3%
15/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.2%
25/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.00%
0/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.4%
11/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.3%
15/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.4%
26/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.2%
3/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
5/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.70%
2/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.50%
1/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
2.1%
6/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.7%
7/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
0.73%
1/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
|
Vascular disorders
Hypertension
|
5.4%
11/202 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
5.3%
15/284 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
6.4%
26/406 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
1.5%
2/137 • All Adverse Events (AEs) are reported in this record from date of First Patient First Treatment (FPFT) until end of treatment exposure, up to 156 weeks, + 84 days safety follow-up.
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER