Trial Outcomes & Findings for Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home (NCT NCT02748018)
NCT ID: NCT02748018
Last Updated: 2025-08-19
Results Overview
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1C \> 8%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
959 participants
Primary outcome timeframe
Baseline and end of 6-month study period
Results posted on
2025-08-19
Participant Flow
Date of first subject enrollment: 25MAY2017, Date of last subject visit (of study period): 09MAY2023 Date of last subject visit (of continuation period): 01NOV2023
870 (298 in CSII Cohort, 248 in MDI Cohort, 324 in SAP Cohort) subjects entered the study period.
Participant milestones
| Measure |
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|---|---|---|---|
|
Study Period
STARTED
|
150
|
148
|
126
|
122
|
164
|
160
|
|
Study Period
COMPLETED
|
140
|
138
|
117
|
109
|
146
|
146
|
|
Study Period
NOT COMPLETED
|
10
|
10
|
9
|
13
|
18
|
14
|
|
Continuation Period
STARTED
|
140
|
138
|
117
|
109
|
146
|
146
|
|
Continuation Period
COMPLETED
|
134
|
127
|
110
|
99
|
131
|
140
|
|
Continuation Period
NOT COMPLETED
|
6
|
11
|
7
|
10
|
15
|
6
|
Reasons for withdrawal
| Measure |
CSII Cohort: Treatment Arm
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
MDI Cohort: Treatment Arm
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
MDI Cohort: Control Arm
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
SAP Cohort: Treatment Arm
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
SAP Cohort: Control Arm
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|---|---|---|---|
|
Study Period
Adverse Event
|
1
|
3
|
4
|
0
|
3
|
3
|
|
Study Period
Withdrawal by Subject
|
7
|
4
|
4
|
11
|
12
|
10
|
|
Study Period
Pregnancy
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Study Period
Physician Decision
|
2
|
2
|
1
|
0
|
2
|
0
|
|
Study Period
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Continuation Period
Adverse Event
|
2
|
0
|
1
|
1
|
1
|
4
|
|
Continuation Period
Withdrawal by Subject
|
3
|
5
|
3
|
9
|
11
|
1
|
|
Continuation Period
Lost to Follow-up
|
0
|
2
|
1
|
0
|
1
|
0
|
|
Continuation Period
Pregnancy
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Continuation Period
Physician Decision
|
0
|
1
|
2
|
0
|
2
|
1
|
|
Continuation Period
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
Baseline characteristics by cohort
| Measure |
CSII Cohort: Treatment Arm
n=150 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=148 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
MDI Cohort: Treatment Arm
n=126 Participants
In the run-in period, subjects were on MDI. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
MDI Cohort: Control Arm
n=122 Participants
In the run-in period, subjects were on MDI. In the study period, subjects continued to use MDI. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
SAP Cohort: Treatment Arm
n=164 Participants
In the run-in period, subjects were on SAP. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
SAP Cohort: Control Arm
n=160 Participants
In the run-in period, subjects were on SAP. In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
Total
n=870 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.0 Years
STANDARD_DEVIATION 19.8 • n=93 Participants
|
35.1 Years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
33.6 Years
STANDARD_DEVIATION 19.6 • n=27 Participants
|
37.9 Years
STANDARD_DEVIATION 19.2 • n=483 Participants
|
36.4 Years
STANDARD_DEVIATION 21.3 • n=36 Participants
|
39.2 Years
STANDARD_DEVIATION 21.4 • n=10 Participants
|
37.1 Years
STANDARD_DEVIATION 20.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
90 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
90 Participants
n=36 Participants
|
83 Participants
n=10 Participants
|
414 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
77 Participants
n=10 Participants
|
456 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=93 Participants
|
144 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
95 Participants
n=483 Participants
|
154 Participants
n=36 Participants
|
156 Participants
n=10 Participants
|
799 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 298 subjects in CSII cohort. 147 subjects have available measurements in the baseline A1C \> 8% group.
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1C \> 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=74 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=73 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Baseline A1C > 8%: Change in A1C (∆A1C)
|
-1.6 Percentage of HbA1c
Standard Deviation 1.3
|
-0.8 Percentage of HbA1c
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 6 months study periodPopulation: Study period: 298 subjects in CSII cohort. 129 subjects have available measurements in the baseline A1C ≤ 8% group.
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=66 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=63 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
|
2.4 Percentage of Time
Standard Deviation 1.9
|
7.3 Percentage of Time
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 248 subjects in MDI cohort. 94 subjects have available measurements in the baseline A1C \> 8% group.
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c \> 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=50 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=44 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
|
-1.4 Percentage of HbA1c
Standard Deviation 1.1
|
-0.6 Percentage of HbA1c
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 6 months study periodPopulation: Study period: 248 subjects in MDI cohort. 120 subjects have available measurements in the baseline A1C ≤ 8% group.
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=65 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=55 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
|
2.8 Percentage of Time
Standard Deviation 2.7
|
7.5 Percentage of Time
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 324 subjects in SAP cohort. 108 subjects have available measurements in the baseline A1C \> 8% group.
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c \> 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=54 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=54 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Baseline A1C > 8%: Change of A1C (∆A1C)
|
-0.6 Percentage of HbA1c
Standard Deviation 0.8
|
-0.6 Percentage of HbA1c
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 6 months study periodPopulation: Study period: 324 subjects in SAP cohort. 177 subjects have available measurements in the baseline A1c ≤ 8% group.
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c ≤ 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=89 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=88 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Baseline A1C ≤ 8%: Time in Hypoglycemic Range
|
2.5 Percentage of Time
Standard Deviation 2.3
|
3.5 Percentage of Time
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 298 subjects in CSII cohort. 136 subjects have available measurements in the baseline A1c \> 8% group.
CSII Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=74 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=62 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
|
2.3 Percentage of Time
Standard Deviation 2.3
|
4.6 Percentage of Time
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 298 subjects in CSII cohort. 131 subjects have available measurements in the baseline A1c ≤ 8% group.
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=66 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=65 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
|
-0.4 Percentage of HbA1c
Standard Deviation 0.5
|
-0.0 Percentage of HbA1c
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 298 subjects in CSII cohort. 264 subjects have available measurements.
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=140 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=124 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Time in Hypoglycemic Range During Night for All Subjects
|
2.3 Percentage of Time
Standard Deviation 3.3
|
7.7 Percentage of Time
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 298 subjects in CSII cohort. 264 subjects have available measurements.
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=140 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=124 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
|
73.8 Percentage of Time
Standard Deviation 14.3
|
55.0 Percentage of Time
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 298 subjects in CSII cohort. 265 subjects have available measurements.
CSII Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=140 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=125 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
|
67.4 Percentage of Time
Standard Deviation 10.8
|
55.4 Percentage of Time
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 298 subjects in CSII cohort. 265 subjects have available measurements.
CSII Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=140 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=125 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
|
2.4 Percentage of Time
Standard Deviation 2.1
|
6.0 Percentage of Time
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 298 subjects in CSII cohort. 278 subjects have available measurements.
CSII Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=140 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=138 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
CSII Cohort: Change in A1C for All Subjects
|
-1.0 Percentage of HbA1c
Standard Deviation 1.2
|
-0.4 Percentage of HbA1c
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 248 subjects in MDI cohort. 88 subjects have available measurements in the baseline A1C \> 8% group.
MDI Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=50 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=38 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
|
1.9 Percentage of Time
Standard Deviation 1.6
|
5.5 Percentage of Time
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 248 subjects in MDI cohort. 130 subjects have available measurements in the baseline A1C ≤ 8% group.
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=65 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=65 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
|
0.0 Percentage of HbA1c
Standard Deviation 0.6
|
-0.1 Percentage of HbA1c
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 248 subjects in MDI cohort. 206 subjects have available measurements.
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=113 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=93 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Time in Hypoglycemic Range During Night for All Subjects
|
1.9 Percentage of Time
Standard Deviation 2.6
|
9.2 Percentage of Time
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 248 subjects in MDI cohort. 206 subjects have available measurements.
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=113 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=93 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
|
75.9 Percentage of Time
Standard Deviation 13.6
|
60.0 Percentage of Time
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 248 subjects in MDI cohort. 208 subjects have available measurements.
MDI Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=115 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=93 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
|
70.6 Percentage of Time
Standard Deviation 11.3
|
57.0 Percentage of Time
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 248 subjects in MDI cohort. 208 subjects have available measurements.
MDI Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=115 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=93 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
|
2.4 Percentage of Time
Standard Deviation 2.3
|
6.7 Percentage of Time
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 248 subjects in MDI cohort. 224 subjects have available measurements.
MDI Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=115 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=109 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
MDI Cohort: Change in A1C for All Subjects
|
-0.6 Percentage of HbA1c
Standard Deviation 1.1
|
-0.3 Percentage of HbA1c
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 324 subjects in SAP cohort. 106 subjects have available measurements in the A1C \> 8% group.
SAP Cohort: Time with sensor glucose (SG) below 70 mg/dL (3.9mmol/L) during the six-month study period, for subjects with baseline A1c \> 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=53 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=53 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Baseline A1C > 8%: Time in Hypoglycemic Range
|
2.5 Percentage of Time
Standard Deviation 1.9
|
2.8 Percentage of Time
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 324 subjects in SAP cohort. 184 subjects have available measurements in the baseline A1c ≤ 8% group.
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit, for subjects with baseline A1c ≤ 8%
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=92 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=92 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Baseline A1C ≤ 8%: Change in A1C (∆A1C)
|
0.0 Percentage of HbA1c
Standard Deviation 0.5
|
0.1 Percentage of HbA1c
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=142 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=141 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Time in Hypoglycemic Range During Night for All Subjects
|
2.5 Percentage of Time
Standard Deviation 3.4
|
3.2 Percentage of Time
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=142 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=141 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Night for All Subjects
|
73.2 Percentage of Time
Standard Deviation 15.4
|
61.0 Percentage of Time
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
SAP Cohort: Time in target range measures the time with SG in target range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=142 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=141 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) During Day and Night for All Subjects
|
65.7 Percentage of Time
Standard Deviation 12.4
|
59.4 Percentage of Time
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: 6 months study periodPopulation: Study period: 324 subjects in SAP cohort. 283 subjects have available measurements.
SAP Cohort: Time with SG below 70 mg/dL (3.9mmol/L) during Day and Night for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=142 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=141 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Time in Hypoglycemic Range During Day and Night for All Subjects
|
2.5 Percentage of Time
Standard Deviation 2.2
|
3.3 Percentage of Time
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and end of 6-month study periodPopulation: Study period: 324 subjects in SAP cohort. 292 subjects have available measurements.
SAP Cohort: Change in A1C from baseline to the end of the six-month treatment period, defined as A1C measured at the six-month treatment visit minus A1C measured at the randomization visit for all subjects
Outcome measures
| Measure |
CSII Cohort: Treatment Arm
n=146 Participants
In the run-in period, subjects were on CSII. In the study period, subjects started using the MiniMed system (i.e., using Auto Mode). In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
CSII Cohort: Control Arm
n=146 Participants
In the run-in period, subjects were on CSII. In the study period, subjects used the MiniMed pump without CGM. In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|
|
SAP Cohort: Change in A1C for All Subjects
|
-0.2 Percentage of HbA1c
Standard Deviation 0.7
|
-0.2 Percentage of HbA1c
Standard Deviation 0.8
|
Adverse Events
CSII Cohort: Treatment Arm Study Period
Serious events: 1 serious events
Other events: 80 other events
Deaths: 0 deaths
CSII Cohort: Control Arm Study Period
Serious events: 4 serious events
Other events: 86 other events
Deaths: 0 deaths
MDI Cohort: Treatment Arm Study Period
Serious events: 3 serious events
Other events: 72 other events
Deaths: 0 deaths
MDI Cohort: Control Arm Study Period
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
SAP Cohort: Treatment Arm Study Period
Serious events: 4 serious events
Other events: 94 other events
Deaths: 0 deaths
SAP Cohort: Control Arm Study Period
Serious events: 6 serious events
Other events: 101 other events
Deaths: 0 deaths
All Patients: Continuation Period
Serious events: 26 serious events
Other events: 395 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSII Cohort: Treatment Arm Study Period
n=150 participants at risk
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
|
CSII Cohort: Control Arm Study Period
n=148 participants at risk
In the study period, subjects used the MiniMed pump without CGM.
|
MDI Cohort: Treatment Arm Study Period
n=126 participants at risk
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
|
MDI Cohort: Control Arm Study Period
n=122 participants at risk
In the study period, subjects continued to use MDI.
|
SAP Cohort: Treatment Arm Study Period
n=164 participants at risk
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
|
SAP Cohort: Control Arm Study Period
n=160 participants at risk
In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode).
|
All Patients: Continuation Period
n=796 participants at risk
In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Appendicitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Cellulitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Depression
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Food allergy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Influenza
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Infusion site cellulitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer stage 0
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
Other adverse events
| Measure |
CSII Cohort: Treatment Arm Study Period
n=150 participants at risk
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
|
CSII Cohort: Control Arm Study Period
n=148 participants at risk
In the study period, subjects used the MiniMed pump without CGM.
|
MDI Cohort: Treatment Arm Study Period
n=126 participants at risk
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
|
MDI Cohort: Control Arm Study Period
n=122 participants at risk
In the study period, subjects continued to use MDI.
|
SAP Cohort: Treatment Arm Study Period
n=164 participants at risk
In the study period, subjects started using the MiniMed system (i.e., using Auto Mode).
|
SAP Cohort: Control Arm Study Period
n=160 participants at risk
In the study period, subjects continued to use SAP therapy using the MiniMed system (SAP without Low Management Suspend on Low, Low Management Suspend before low or Auto Mode).
|
All Patients: Continuation Period
n=796 participants at risk
In the continuation period, all subjects were using the Hybrid Closed Loop system.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Gastrointestinal disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Abscess limb
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Acute kidney injury
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Adverse drug reaction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Anxiety
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.75%
6/796 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Appendicitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
1.8%
3/164 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.88%
7/796 • Number of events 8 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Surgical and medical procedures
Artificial crown procedure
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Astigmatism
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Atypical pneumonia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.8%
3/164 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.63%
5/796 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Biopsy skin
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Blepharitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Blood calcium abnormal
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Blood ketone body increased
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Blood pressure increased
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Blood pressure increased
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Body tinea
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Bronchitis
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.3%
10/796 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
COVID-19
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.63%
5/796 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Calcinosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Candida infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Cardiac murmur
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Cataract
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Catheter site abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Cellulitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Chalazion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Chest pain
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Chronic spontaneous urticaria
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Concussion
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
3/150 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.7%
4/148 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
3.0%
5/164 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.88%
7/796 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Croup infectious
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Cystitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Degenerative bone disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Dental caries
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Depression
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
3/148 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.75%
6/796 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Product Issues
Device breakage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Diabetic retinopathy
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.0%
8/796 • Number of events 8 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Diplopia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Dizziness
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Dry eye
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Dyspepsia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Ear infection
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Ear lobe infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Epididymitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Eye allergy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Eye infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Eye irritation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Eye pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Eye ulcer
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Fatigue
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Folliculitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Food allergy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Food poisoning
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.67%
1/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Foreign body in reproductive tract
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Fungal infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
3.4%
5/148 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
3.7%
6/164 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
16/796 • Number of events 20 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Gastroenteritis norovirus
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
6.1%
10/164 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
4/160 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.1%
9/796 • Number of events 9 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Genital infection fungal
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Gluten sensitivity
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Haematoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Head injury
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Headache
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.88%
7/796 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Herpes zoster cutaneous disseminated
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Hordeolum
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Hunger
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.3%
11/150 • Number of events 13 • 6 months of Study Period, 6 months of Continuation Period
|
16.2%
24/148 • Number of events 40 • 6 months of Study Period, 6 months of Continuation Period
|
13.5%
17/126 • Number of events 22 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
12.2%
20/164 • Number of events 25 • 6 months of Study Period, 6 months of Continuation Period
|
15.0%
24/160 • Number of events 37 • 6 months of Study Period, 6 months of Continuation Period
|
8.8%
70/796 • Number of events 97 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Hypertension
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Hypoaesthesia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
2.7%
4/148 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
4/160 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.3%
10/796 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
|
Endocrine disorders
Hypothyroidism
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Impetigo
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Infected cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Infectious mononucleosis
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Influenza
|
3.3%
5/150 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
3/148 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
1.8%
3/164 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
4/160 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.3%
10/796 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Influenza like illness
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Infusion site abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site bruising
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Infusion site cellulitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site erythema
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site haematoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site inflammation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site rash
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Infusion site reaction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Injection site pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Injection site swelling
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Intersection syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Surgical and medical procedures
Intra-uterine contraceptive device insertion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Investigation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Syncope
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Laryngitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Lenticular opacities
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Localised infection
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Lyme disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Major depression
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Malaise
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Mallet finger
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site bruise
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site dryness
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site erosion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site erythema
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.88%
7/796 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site haematoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site haemorrhage
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.63%
5/796 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site hypersensitivity
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site inflammation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site irritation
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
3.2%
4/126 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site laceration
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site pruritus
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site rash
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.88%
7/796 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site reaction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
4/164 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.63%
5/796 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site swelling
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Medical device site vesicles
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Migraine
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
3/148 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Mite allergy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Molluscum contagiosum
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.8%
3/164 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.75%
6/796 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Myopia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Myringitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
9/150 • Number of events 11 • 6 months of Study Period, 6 months of Continuation Period
|
6.8%
10/148 • Number of events 13 • 6 months of Study Period, 6 months of Continuation Period
|
5.6%
7/126 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
8.2%
10/122 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
5.5%
9/164 • Number of events 11 • 6 months of Study Period, 6 months of Continuation Period
|
6.9%
11/160 • Number of events 13 • 6 months of Study Period, 6 months of Continuation Period
|
6.5%
52/796 • Number of events 56 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Non-proliferative retinopathy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Oedema peripheral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Omphalitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Oral herpes
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.75%
6/796 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Otitis externa
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Otitis media
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Pain
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.75%
6/796 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Palpitations
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Paronychia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Perianal cyst
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Peripheral swelling
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Pertussis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Pharyngitis
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.0%
8/796 • Number of events 9 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Photopsia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Pinguecula
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Pneumonia
|
2.0%
3/150 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Posterior capsule opacification
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Presyncope
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Psychological factor affecting medical condition
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Pyrexia
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
3.2%
4/126 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.8%
3/164 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
10/150 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
3.4%
5/148 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.75%
6/796 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
3/150 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
3/148 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Retinal disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Retinal tear
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Retinopathy proliferative
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Rhinitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Sciatica
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
3/126 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
3.3%
4/122 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Seizure
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Sever's disease
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Sinusitis
|
3.3%
5/150 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
3/148 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
2.4%
4/164 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
3/160 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
1.9%
15/796 • Number of events 15 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Skin infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.7%
4/150 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.63%
5/796 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Social anxiety disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Somnolence
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Spinal segmental dysfunction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Staphylococcal infection
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Psychiatric disorders
Stress
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Tension headache
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Endocrine disorders
Thyroid disorder
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Tinea infection
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Tooth abscess
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Tooth infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
2.5%
3/122 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.38%
3/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Tractional retinal detachment
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Musculoskeletal and connective tissue disorders
Ulnocarpal abutment syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Upper respiratory tract congestion
|
4.0%
6/150 • Number of events 7 • 6 months of Study Period, 6 months of Continuation Period
|
4.1%
6/148 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
3.2%
4/126 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
8.2%
10/122 • Number of events 10 • 6 months of Study Period, 6 months of Continuation Period
|
3.7%
6/164 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
6.2%
10/160 • Number of events 11 • 6 months of Study Period, 6 months of Continuation Period
|
4.4%
35/796 • Number of events 37 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.3%
2/150 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Urinary tract infection
|
2.7%
4/150 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
2.0%
16/796 • Number of events 19 • 6 months of Study Period, 6 months of Continuation Period
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
General disorders
Vaccination site pain
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Vascular disorders
Varicose vein
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Viral infection
|
2.0%
3/150 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
4.0%
5/126 • Number of events 6 • 6 months of Study Period, 6 months of Continuation Period
|
1.6%
2/122 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/164 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
11/796 • Number of events 13 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.63%
5/796 • Number of events 5 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Vision blurred
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Visual impairment
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Vitamin D decreased
|
0.67%
1/150 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/150 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
6.3%
8/126 • Number of events 9 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
1.8%
3/164 • Number of events 3 • 6 months of Study Period, 6 months of Continuation Period
|
1.2%
2/160 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
1.3%
10/796 • Number of events 11 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
1.4%
2/148 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
|
Investigations
Weight increased
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.62%
1/160 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.79%
1/126 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.50%
4/796 • Number of events 4 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.13%
1/796 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
|
Infections and infestations
Wound infection
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.61%
1/164 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.68%
1/148 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/122 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/796 • 6 months of Study Period, 6 months of Continuation Period
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/150 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/148 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/126 • 6 months of Study Period, 6 months of Continuation Period
|
0.82%
1/122 • Number of events 1 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/164 • 6 months of Study Period, 6 months of Continuation Period
|
0.00%
0/160 • 6 months of Study Period, 6 months of Continuation Period
|
0.25%
2/796 • Number of events 2 • 6 months of Study Period, 6 months of Continuation Period
|
Additional Information
Colleen Haberman, Sr. Clinical Research Manager
Medtronic Diabetes
Phone: 6127503275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees not to publish until 12 months from trial completion or until sponsor publishes multi-center results, whichever occurs first. In either case, sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period more than 60 days but less than or equal to 180 days from the date that the communication is submitted to sponsor for review. Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER