Trial Outcomes & Findings for Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE) (NCT NCT01636687)
NCT ID: NCT01636687
Last Updated: 2018-09-27
Results Overview
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
COMPLETED
PHASE3
182 participants
12 weeks
2018-09-27
Participant Flow
59 placebo subjects completed induction phase. These 59 entered maintenance phase. Of those, 28 were assigned to 150mg AIN457 and 28 were assigned to 300 mg AIN457, while 3 remained with PLC treatment.
A total of 220 patients were screened at 39 study centers, and 182 patients were randomized at 38 study centers to 3 balanced groups.
Participant milestones
| Measure |
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Induction Period
STARTED
|
61
|
60
|
0
|
0
|
61
|
|
Induction Period
COMPLETED
|
58
|
60
|
0
|
0
|
59
|
|
Induction Period
NOT COMPLETED
|
3
|
0
|
0
|
0
|
2
|
|
Maintenance Period
STARTED
|
58
|
60
|
28
|
28
|
3
|
|
Maintenance Period
COMPLETED
|
50
|
58
|
26
|
28
|
1
|
|
Maintenance Period
NOT COMPLETED
|
8
|
2
|
2
|
0
|
2
|
|
Extension Period
STARTED
|
47
|
54
|
25
|
28
|
0
|
|
Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Extension Period
NOT COMPLETED
|
47
|
54
|
25
|
28
|
0
|
|
Follow-up Period
STARTED
|
38
|
45
|
21
|
20
|
2
|
|
Follow-up Period
COMPLETED
|
37
|
45
|
21
|
20
|
1
|
|
Follow-up Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
AIN457 150 mg
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo - AIN457 150 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo - AIN457 300mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 300 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Induction Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Induction Period
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
|
Induction Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Induction Period
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
2
|
0
|
2
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Lack of Efficacy
|
4
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Lost to Follow-up
|
1
|
1
|
0
|
0
|
1
|
|
Maintenance Period
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Extension Period
technical problems
|
0
|
1
|
2
|
1
|
0
|
|
Extension Period
Adverse Event
|
4
|
3
|
2
|
1
|
0
|
|
Extension Period
Lack of Efficacy
|
7
|
0
|
2
|
1
|
0
|
|
Extension Period
Lost to Follow-up
|
1
|
0
|
1
|
0
|
0
|
|
Extension Period
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
|
Extension Period
study terminated by sponsor
|
33
|
50
|
17
|
23
|
0
|
|
Extension Period
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)
Baseline characteristics by cohort
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 14.23 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 13.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Full Analysis Set (FAS) comprises of all patients to whom study treatment has been assigned.
Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis. PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score.
Outcome measures
| Measure |
AIN457 150 mg
n=60 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
PASI 75
|
71.7 Percentages of participants
|
86.7 Percentages of participants
|
3.3 Percentages of participants
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response
IGA 0/1
|
53.3 Percentages of participants
|
73.3 Percentages of participants
|
0.0 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.
To assess the subject's ability to follow instructions for use with the secukinumab autoinjector
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=60 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Subjects With Successful Self-administration of Study Drug at Week 1
|
100 Percentages of participants
|
100 Percentages of participants
|
100 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1Population: Safety set
To assess potential use-related hazards with the secukinumab autoinjector for the subject.
Outcome measures
| Measure |
AIN457 150 mg
n=59 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=58 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=60 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Possible Use-related Hazards
Needle stick in non-critical area
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Needle stick in a critical area
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Any part of the device swallowed
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Allergic reaction to devise material
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Pain due to bent needle
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Any breakage of the device
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Swallowing of material debris observed
|
0 Percentages of participants
|
0 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Any other problem
|
0 Percentages of participants
|
5.1 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
|
Percentage of Subjects With Possible Use-related Hazards
Less than full dose administered
|
0 Percentages of participants
|
1.7 Percentages of participants
|
0 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Safety Set
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
Feelings about injections
|
0.94 Score
Standard Deviation 2.190
|
1.13 Score
Standard Deviation 1.796
|
0.93 Score
Standard Deviation 1.887
|
—
|
—
|
|
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
Self confidence
|
1.76 Score
Standard Deviation 1.763
|
1.68 Score
Standard Deviation 1.901
|
1.00 Score
Standard Deviation 2.098
|
—
|
—
|
|
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
Satisfaction with self-injection
|
2.74 Score
Standard Deviation 2.741
|
2.63 Score
Standard Deviation 2.361
|
1.71 Score
Standard Deviation 2.679
|
—
|
—
|
SECONDARY outcome
Timeframe: Absolute change from baseline at week 48Population: Safety set
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; "0" corresponds to worst experience while "10" corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Outcome measures
| Measure |
AIN457 150 mg
n=58 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
n=3 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
Feelings about injections
|
0.92 Score
Standard Deviation 1.853
|
1.34 Score
Standard Deviation 2.336
|
1.43 Score
Standard Deviation 2.049
|
0.73 Score
Standard Deviation 1.450
|
0.42 Score
Standard Deviation 1.768
|
|
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
Self confidence
|
1.88 Score
Standard Deviation 1.926
|
1.86 Score
Standard Deviation 2.052
|
1.17 Score
Standard Deviation 3.033
|
1.70 Score
Standard Deviation 2.145
|
0.00 Score
Standard Deviation 3.536
|
|
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
Satisfaction with self-injection
|
2.93 Score
Standard Deviation 2.853
|
2.50 Score
Standard Deviation 2.121
|
2.29 Score
Standard Deviation 2.650
|
1.98 Score
Standard Deviation 2.853
|
2.50 Score
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS)
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period
PASI 50
|
78.3 Percentages of participants
|
96.7 Percentages of participants
|
8.2 Percentages of participants
|
—
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period
PASI 90
|
40.0 Percentages of participants
|
55.0 Percentages of participants
|
0.0 Percentages of participants
|
—
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period
PASI 100
|
16.7 Percentages of participants
|
26.7 Percentages of participants
|
0.0 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 up to Week 52Population: Full Analysis Set (FAS). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
Week 52 IGA 0/1
|
64.7 Percentages of participants
|
70.7 Percentages of participants
|
56.0 Percentages of participants
|
85.7 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
Week 52 PASI 75
|
82.4 Percentages of participants
|
82.8 Percentages of participants
|
76.0 Percentages of participants
|
96.4 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
Week 52 PASI 50
|
96.1 Percentages of participants
|
94.8 Percentages of participants
|
88.0 Percentages of participants
|
100.0 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
Week 52 PASI 90
|
62.7 Percentages of participants
|
65.5 Percentages of participants
|
52.0 Percentages of participants
|
89.3 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)
Week 52 PASI 100
|
35.3 Percentages of participants
|
39.7 Percentages of participants
|
40.0 Percentages of participants
|
64.3 Percentages of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (FAS)
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline for PASI Score - Induction Period
|
-15.52 Units on a scale
Standard Deviation 7.841
|
-16.67 Units on a scale
Standard Deviation 6.552
|
-1.26 Units on a scale
Standard Deviation 6.621
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full Analysis Set (FAS)
Psoriasis Area and Severity Index (PASI): Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)
|
-18.3 Units on a scale
Standard Deviation 6.75
|
-16.4 Units on a scale
Standard Deviation 5.99
|
-15.2 Units on a scale
Standard Deviation 5.85
|
-18.8 Units on a scale
Standard Deviation 5.59
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS) - All patients to whom study treatment was assigned.
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
mild
|
25.0 Percentages of participants
|
18.3 Percentages of participants
|
8.2 Percentages of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
clear
|
18.3 Percentages of participants
|
30.0 Percentages of participants
|
0.0 Percentages of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
almost clear
|
35.0 Percentages of participants
|
45.0 Percentages of participants
|
0.0 Percentages of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
moderate
|
15.0 Percentages of participants
|
6.7 Percentages of participants
|
60.7 Percentages of participants
|
—
|
—
|
|
Percentage of Participants in Each IGA Mod 2011 Category - Induction Period
severe
|
6.7 Percentages of participants
|
0.0 Percentages of participants
|
31.1 Percentages of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS)
The Investigators' Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
Clear
|
35.3 Percentages of participants
|
39.7 Percentages of participants
|
40.0 Percentages of participants
|
64.3 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
Almost clear
|
29.4 Percentages of participants
|
31.0 Percentages of participants
|
16.0 Percentages of participants
|
21.4 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
Mild
|
19.6 Percentages of participants
|
19.0 Percentages of participants
|
24.0 Percentages of participants
|
10.7 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
Moderate
|
11.8 Percentages of participants
|
6.9 Percentages of participants
|
20.0 Percentages of participants
|
3.6 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)
Severe
|
3.9 Percentages of participants
|
3.4 Percentages of participants
|
0.0 Percentages of participants
|
0.0 Percentages of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=61 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Change From Baseline in EQ-5D up to Week 12 - Induction Period
|
13.5 unit on a scale
Standard Deviation 19.63
|
15.3 unit on a scale
Standard Deviation 19.80
|
-0.5 unit on a scale
Standard Deviation 14.89
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state).
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
n=3 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period
|
16.8 unit on a scale
Standard Deviation 20.34
|
17.4 unit on a scale
Standard Deviation 20.38
|
12.9 unit on a scale
Standard Deviation 28.45
|
9.9 unit on a scale
Standard Deviation 10.94
|
10.0 unit on a scale
Standard Deviation 9.00
|
SECONDARY outcome
Timeframe: Baseline, up to Week 12Population: Full Analysis Set (FAS)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. A negative median percent change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=56 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=55 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=55 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period
|
-83.3 percent change
Interval -88.9 to -75.0
|
-86.8 percent change
Interval -95.0 to -82.5
|
-17.9 percent change
Interval -32.7 to -1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full Analysis Set (FAS)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. A negative median percent change from baseline indicates improvement.
Outcome measures
| Measure |
AIN457 150 mg
n=56 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=55 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=25 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=27 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
n=3 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period
|
-90.9 Percent change
Interval -95.0 to -85.0
|
-91.2 Percent change
Interval -94.7 to -84.2
|
-78.5 Percent change
Interval -90.0 to -59.5
|
-97.7 Percent change
Interval -100.0 to -81.3
|
-53.7 Percent change
Interval -72.7 to
Too few events to calculate the upper limit.
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Outcome measures
| Measure |
AIN457 150 mg
n=59 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=59 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=59 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period
|
59.3 Percentage of participants
|
74.6 Percentage of participants
|
15.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) - All patients to whom study treatment was assigned.
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.
Outcome measures
| Measure |
AIN457 150 mg
n=59 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
n=3 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)
|
66.1 Percentage of participants
|
70.0 Percentage of participants
|
57.1 Percentage of participants
|
85.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 160Population: Full analysis set (FAS). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
IGA 0/1 Week 160
|
43.8 Percentages of participants
|
58.3 Percentages of participants
|
20.0 Percentages of participants
|
73.3 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI 75 Week 160
|
93.8 Percentages of participants
|
87.5 Percentages of participants
|
70.0 Percentages of participants
|
86.7 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI 50 Week 160
|
100.0 Percentages of participants
|
100.0 Percentages of participants
|
70.0 Percentages of participants
|
100.0 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI 90 Week 160
|
62.5 Percentages of participants
|
70.8 Percentages of participants
|
40.0 Percentages of participants
|
73.3 Percentages of participants
|
—
|
|
Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)
PASI 100 (n=16, 24, 10, 15) Week 160
|
31.3 Percentages of participants
|
45.8 Percentages of participants
|
20.0 Percentages of participants
|
60.0 Percentages of participants
|
—
|
SECONDARY outcome
Timeframe: Week 160Population: Full analysis set (FAS).
PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)
|
-18.7 Units on a scale
Standard Deviation 5.66
|
-15.9 Units on a scale
Standard Deviation 4.58
|
-12.7 Units on a scale
Standard Deviation 8.08
|
-18.1 Units on a scale
Standard Deviation 5.49
|
—
|
SECONDARY outcome
Timeframe: Week 160Population: Full analysis set (FAS).
The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Outcome measures
| Measure |
AIN457 150 mg
n=61 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
severe Week 160
|
0.0 Percentages of participants
|
4.2 Percentages of participants
|
10.0 Percentages of participants
|
6.7 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
clear Week 160
|
25.0 Percentages of participants
|
45.8 Percentages of participants
|
20.0 Percentages of participants
|
60.0 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
almost clear Week 160
|
18.8 Percentages of participants
|
12.5 Percentages of participants
|
0.0 Percentages of participants
|
13.3 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
mild Week 160
|
31.3 Percentages of participants
|
20.8 Percentages of participants
|
50.0 Percentages of participants
|
6.7 Percentages of participants
|
—
|
|
Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
moderate Week 160
|
25.0 Percentages of participants
|
16.7 Percentages of participants
|
20.0 Percentages of participants
|
13.3 Percentages of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216Population: FAS
The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.
Outcome measures
| Measure |
AIN457 150 mg
n=59 Participants
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
AIN457 300 mg
n=60 Participants
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Placebo
n=28 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
Placebo - AIN457 300 mg
n=28 Participants
Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12, were re randomized to AIN457 150 mg for the remainder of the study.
|
Placebo
n=3 Participants
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|
|
Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies
|
1 Number of participants
|
2 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
Adverse Events
Induction AIN457 150 mg
Induction AIN457 300 mg
Induction Placebo
Entire Any AIN457 150 mg
Entire Any AIN457 300 mg
Entire Placebo
Serious adverse events
| Measure |
Induction AIN457 150 mg
n=61 participants at risk
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
Induction AIN457 300 mg
n=60 participants at risk
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Induction Placebo
n=61 participants at risk
placebo secukinumab (2 s.c. injections) at each dosing
|
Entire Any AIN457 150 mg
n=89 participants at risk
Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups.
|
Entire Any AIN457 300 mg
n=88 participants at risk
Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups.
|
Entire Placebo
n=61 participants at risk
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
POSTINFARCTION ANGINA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Eye disorders
AMAUROSIS FUGAX
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Eye disorders
CATARACT
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
ASCITES
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
RECTAL PROLAPSE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
CHRONIC TONSILLITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
MYELITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
PNEUMONIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
BONE CONTUSION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
DISLOCATION OF VERTEBRA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
HEART RATE IRREGULAR
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOLYSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANOGENITAL WARTS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BOWEN'S DISEASE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA IN SITU
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
CAROTID ARTERY ANEURYSM
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Renal and urinary disorders
BLADDER PROLAPSE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
TRANSIENT ACANTHOLYTIC DERMATOSIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
Other adverse events
| Measure |
Induction AIN457 150 mg
n=61 participants at risk
Patients received one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection at each dosing. In the open label phase only one 150 mg s.c. injection at each dosing.
|
Induction AIN457 300 mg
n=60 participants at risk
Patients received two secukinumab 150 mg s.c. injections at each dosing. In the open label phase only two 150 mg s.c. injections at each dosing.
|
Induction Placebo
n=61 participants at risk
placebo secukinumab (2 s.c. injections) at each dosing
|
Entire Any AIN457 150 mg
n=89 participants at risk
Includes all patients in the AIN457 150 mg and in the placebo- AIN457 150 mg treatment groups.
|
Entire Any AIN457 300 mg
n=88 participants at risk
Includes all patients in the AIN457 300 mg and in the placebo- AIN457 300 mg treatment groups.
|
Entire Placebo
n=61 participants at risk
placebo secukinumab (2 s.c. injections) at each dosing
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
BRONCHITIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.7%
6/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
12.5%
11/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
CONJUNCTIVITIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.8%
6/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Eye disorders
BLEPHARITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.7%
6/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
8.0%
7/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.6%
5/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.7%
5/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
CYST
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
FATIGUE
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
INJECTION SITE BRUISING
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
INJECTION SITE HAEMATOMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
INJECTION SITE PAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
General disorders
PYREXIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.7%
5/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
FOLLICULITIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
GASTROENTERITIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.7%
6/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
8.0%
7/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
GASTROINTESTINAL VIRAL INFECTION
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
HORDEOLUM
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
INFLUENZA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
9.0%
8/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
NASOPHARYNGITIS
|
23.0%
14/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
31.7%
19/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
14.8%
9/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
41.6%
37/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
44.3%
39/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
14.8%
9/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
ORAL HERPES
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
PERIODONTITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.6%
5/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.7%
5/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
PULPITIS DENTAL
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
PYURIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
RHINITIS
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.7%
6/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
SINUSITIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.0%
3/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.6%
5/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
8.0%
7/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
TONSILLITIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
TOOTH ABSCESS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
19.1%
17/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
10.2%
9/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
BLOOD URINE PRESENT
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Investigations
WEIGHT INCREASED
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Metabolism and nutrition disorders
VITAMIN B12 DEFICIENCY
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
12.4%
11/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
10.2%
9/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.6%
5/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
10.2%
9/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
FIBROMYALGIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
HEADACHE
|
8.2%
5/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.0%
3/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.9%
3/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
14.6%
13/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
15.9%
14/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.9%
3/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH DEPRESSED MOOD
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Psychiatric disorders
INSOMNIA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.8%
6/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.7%
5/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.0%
3/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.6%
5/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
11.4%
10/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.2%
2/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
9.1%
8/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.7%
5/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
5.6%
5/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
INTERTRIGO
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
PITYRIASIS ROSEA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.7%
4/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
8.0%
7/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.7%
6/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
8.0%
7/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.6%
1/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.3%
2/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
3.4%
3/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Skin and subcutaneous tissue disorders
STASIS DERMATITIS
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.1%
1/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
2.3%
2/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
0.00%
0/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
|
Vascular disorders
HYPERTENSION
|
4.9%
3/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
1.7%
1/60 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.6%
4/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
4.5%
4/89 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
11.4%
10/88 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
6.6%
4/61 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.
|
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