Trial Outcomes & Findings for An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA (NCT NCT02557295)
NCT ID: NCT02557295
Last Updated: 2024-11-26
Results Overview
* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion reactions associated with shortened infusion duration * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction
Recruitment status
TERMINATED
Target enrollment
248 participants
Primary outcome timeframe
Duration of study participation (up to 5 years)
Results posted on
2024-11-26
Participant Flow
Participant flow was summarized by all analysis groups as prespecified in Statistical Analysis Plan. According to study protocol inclusion criteria, without prior RA medication restrictions, patients who received Remsima, Remicade, Other anti-TNF and biologic naïve were enrolled and switching between were allowed
A total of 302 patients were screened, and 248 patients were enrolled.
Participant milestones
| Measure |
Remsima
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
111
|
8
|
15
|
3
|
0
|
0
|
81
|
7
|
23
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
111
|
8
|
15
|
3
|
0
|
0
|
81
|
7
|
23
|
Reasons for withdrawal
| Measure |
Remsima
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
4
|
0
|
0
|
0
|
15
|
1
|
3
|
|
Overall Study
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
24
|
1
|
3
|
0
|
0
|
0
|
12
|
1
|
0
|
|
Overall Study
Adverse Event
|
16
|
2
|
3
|
0
|
0
|
0
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
|
Overall Study
Study Close
|
54
|
3
|
5
|
3
|
0
|
0
|
37
|
3
|
19
|
|
Overall Study
except for study close
|
4
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
0
|
Baseline Characteristics
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA
Baseline characteristics by cohort
| Measure |
Remsima
n=111 Participants
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima I
n=8 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=15 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group
|
Remicade
n=3 Participants
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
n=81 Participants
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=7 Participants
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
n=23 Participants
Patients who received only non-biologic treatment will be included in this analysis group.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
n=5 Participants
|
57.5 years
n=7 Participants
|
56 years
n=5 Participants
|
53.0 years
n=4 Participants
|
—
|
—
|
53.0 years
n=8 Participants
|
44 years
n=24 Participants
|
54 years
n=42 Participants
|
54.6 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
—
|
—
|
65 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
198 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
—
|
16 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
98 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
—
|
—
|
74 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
226 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
—
|
7 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Duration of study participation (up to 5 years)Population: The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used. All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade I" and "Switch to Remicade II" groups.
* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion reactions associated with shortened infusion duration * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction
Outcome measures
| Measure |
Remsima
n=111 Participants
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima I
n=8 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=15 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
n=3 Participants
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
n=81 Participants
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=7 Participants
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
n=23 Participants
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Serious infections including sepsis (excluding opportunistic infections and tuberculosis)
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of tuberculosis
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Haematological reactions
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Systemic lupus erythematosus/lupus-like syndrom
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Hepatobiliary events
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Malignancies (excluding lymphoma)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Infusion reactions associated with shortened infusion duration
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
TEAE of Infusion related reaction/hypersensitivity/ anaphylactic reaction
|
15 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 ~ Week 198 (every 6 months ±6 weeks)Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.
Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96 Where: TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm) Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity: Remission: DAS28 \< 2.6 Low Disease Activity: 2.6 ≤ DAS28 \< 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 \< DAS28
Outcome measures
| Measure |
Remsima
n=80 Participants
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima I
n=3 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Day 0 DAS28 (ESR)
|
5.698 score on a scale
Standard Deviation 1.1035
|
4.212 score on a scale
Standard Deviation 1.6056
|
5.195 score on a scale
Standard Deviation 0.8118
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 30 DAS28 (ESR)
|
3.575 score on a scale
Standard Deviation 1.4181
|
3.833 score on a scale
Standard Deviation 1.5004
|
3.509 score on a scale
Standard Deviation 2.2685
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 54 DAS28 (ESR)
|
3.574 score on a scale
Standard Deviation 1.3803
|
3.877 score on a scale
Standard Deviation 1.3921
|
1.456 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 78 DAS28 (ESR)
|
3.028 score on a scale
Standard Deviation 1.2306
|
—
|
1.282 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 102 DAS28 (ESR)
|
2.780 score on a scale
Standard Deviation 0.7859
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 126 DAS28 (ESR)
|
2.573 score on a scale
Standard Deviation 0.6413
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 150 DAS28 (ESR)
|
2.300 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 174 DAS28 (ESR)
|
2.090 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 198 DAS28 (ESR)
|
3.100 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Day 0 DAS28 (CRP)
|
5.016 score on a scale
Standard Deviation 1.1541
|
3.172 score on a scale
Standard Deviation 2.0141
|
4.763 score on a scale
Standard Deviation 0.9537
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 30 DAS28 (CRP)
|
2.969 score on a scale
Standard Deviation 1.2336
|
2.775 score on a scale
Standard Deviation 1.3919
|
3.665 score on a scale
Standard Deviation 1.7950
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 54 DAS28 (CRP)
|
2.963 score on a scale
Standard Deviation 1.3779
|
2.854 score on a scale
Standard Deviation 1.3705
|
1.172 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 78 DAS28 (CRP)
|
2.583 score on a scale
Standard Deviation 1.0857
|
—
|
1.219 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 102 DAS28 (CRP)
|
1.979 score on a scale
Standard Deviation 0.7980
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 126 DAS28 (CRP)
|
2.200 score on a scale
Standard Deviation 0.7632
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 150 DAS28 (CRP)
|
2.050 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 174 DAS28 (CRP)
|
2.720 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Week 198 DAS28 (CRP)
|
2.680 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 ~ Week 198 (every 6 months ±6 weeks)Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.
The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability. There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3. Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.
Outcome measures
| Measure |
Remsima
n=80 Participants
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima I
n=3 Participants
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=3 Participants
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Day 0 HAQ
|
1.0377 score on a scale
Standard Deviation 0.64472
|
0.5417 score on a scale
Standard Deviation 0.83229
|
1.1875 score on a scale
Standard Deviation 1.14905
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 30 HAQ
|
0.6141 score on a scale
Standard Deviation 0.60167
|
0.5000 score on a scale
Standard Deviation 0.50000
|
0.7500 score on a scale
Standard Deviation 1.08972
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 54 HAQ
|
0.7173 score on a scale
Standard Deviation 0.69955
|
0.3333 score on a scale
Standard Deviation 0.47324
|
0.4583 score on a scale
Standard Deviation 0.59073
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 78 HAQ
|
0.6813 score on a scale
Standard Deviation 0.63670
|
—
|
0.0000 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 102 HAQ
|
0.6364 score on a scale
Standard Deviation 0.52278
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 126 HAQ
|
0.2917 score on a scale
Standard Deviation 0.40182
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 150 HAQ
|
0.1250 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 174 HAQ
|
0.0000 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Week 198 HAQ
|
0.6250 score on a scale
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Remsima
Serious events: 16 serious events
Other events: 56 other events
Deaths: 0 deaths
Switch to Remsima I
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Switch to Remsima II
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Remicade
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Switch to Remicade I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Switch to Remicade II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Anti-TNF
Serious events: 11 serious events
Other events: 39 other events
Deaths: 0 deaths
Switch to Other Anti-TNF
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Biologic Naïve
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remsima
n=111 participants at risk
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima I
n=8 participants at risk
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=15 participants at risk
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
n=3 participants at risk
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
n=81 participants at risk
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=7 participants at risk
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
n=23 participants at risk
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Eye disorders
Cataract
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
General disorders
Oedema
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
General disorders
Pain
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Arthritis bacterial
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Otitis Media
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Pneumonia
|
1.8%
2/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Pyelonephritis acute
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Fall
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.8%
2/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Nervous system disorders
Headache
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Skin and subcutaneous tissue disorders
Urticarial vasculitis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
Other adverse events
| Measure |
Remsima
n=111 participants at risk
Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
|
Switch to Remsima I
n=8 participants at risk
Patients who switched from Remicade to Remsima were included in this analysis group.
|
Switch to Remsima II
n=15 participants at risk
Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
|
Remicade
n=3 participants at risk
Patients who have received only Remicade or switched from non-biologic treatment to Remicade were included in this analysis group.
|
Switch to Remicade I
Patients who switched from Remsima to Remicade were included in this analysis group.
|
Switch to Remicade II
Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
|
Other Anti-TNF
n=81 participants at risk
Following patients were included in other anti-TNF group.
* Patients who have received only anti-TNF other than Remsima or Remicade
* Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade
* Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
|
Switch to Other Anti-TNF
n=7 participants at risk
Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group.
|
Biologic Naïve
n=23 participants at risk
Patients who received only non-biologic treatment will be included in this analysis group.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
3.7%
3/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.8%
2/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
2.5%
2/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Oesophageal discomfort
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Hepatic Cyst
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Immune system disorders
Hypersensitivity
|
11.7%
13/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
13.3%
2/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
2.5%
2/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Latent Tuberculosis
|
6.3%
7/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.2%
5/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
10/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
8.6%
7/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
14.3%
1/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Tinea Pedis
|
3.6%
4/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.0%
10/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
14.8%
12/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Investigations
Hepatic Enzyme Increased
|
1.8%
2/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
3.7%
3/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.9%
4/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Reproductive system and breast disorders
Lactation Disorder
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
4/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.2%
5/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
33.3%
1/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
3.7%
3/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
6/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.6%
4/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Vascular disorders
Hypertension
|
3.6%
4/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
2.5%
2/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Eye disorders
Cataract
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Eye disorders
Dry eye
|
1.8%
2/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
8.7%
2/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Eye disorders
Vision blurred
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Gastrointestinal disorders
Gastritis
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
General disorders
Chest pain
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
General disorders
Injection site pruritus
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
14.3%
1/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
General disorders
Oedema
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
General disorders
Swelling face
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
14.3%
1/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
12.5%
1/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
1.2%
1/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Localized Infection
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Investigations
Liver function test increased
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
2.5%
2/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
3/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
13.3%
2/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
6.7%
1/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Nervous system disorders
Paraesthesia
|
0.90%
1/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Reproductive system and breast disorders
Menopausal disorder
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
|
Respiratory, thoracic and mediastinal disorders
Dydspnoea exertional
|
0.00%
0/111 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/8 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/15 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/3 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
—
0/0 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/81 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
0.00%
0/7 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
4.3%
1/23 • Duration of study participation (up to 5 years)
The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place