Trial Outcomes & Findings for Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus (NCT NCT01368081)
NCT ID: NCT01368081
Last Updated: 2014-06-17
Results Overview
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1162 participants
Primary outcome timeframe
After the first drug intake until 7 days after the last treatment administration, up to 383 days
Results posted on
2014-06-17
Participant Flow
Participant milestones
| Measure |
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
|
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
|
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
136
|
137
|
63
|
68
|
65
|
137
|
136
|
69
|
70
|
68
|
71
|
70
|
70
|
|
Overall Study
COMPLETED
|
126
|
128
|
59
|
63
|
63
|
127
|
124
|
62
|
62
|
58
|
62
|
67
|
63
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
4
|
5
|
2
|
10
|
12
|
7
|
8
|
10
|
9
|
3
|
7
|
Reasons for withdrawal
| Measure |
Sulfonylurea: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha Glucosidase Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
Alpha Glucosidase Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
DPP-IV Inhibitor: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
|
DPP-IV Inhibitor: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP-IV) inhibitor
|
Glinide: Empa 10mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
3
|
2
|
2
|
5
|
6
|
2
|
3
|
5
|
6
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
1
|
0
|
3
|
4
|
2
|
5
|
4
|
3
|
2
|
0
|
|
Overall Study
Other reason not defined above
|
2
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
1
|
0
|
0
|
3
|
Baseline Characteristics
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Sulfonylurea: Empa 10mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
n=63 Participants
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
n=65 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha Glucosidase Inhibitor: Empa 10mg
n=69 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
Alpha Glucosidase Inhibitor: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
DPP-IV Inhibitor: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
DPP-IV Inhibitor: Empa 25mg
n=71 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
Glinide: Empa 10mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Total
n=1160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
60.4 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
59.7 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
63.5 years
STANDARD_DEVIATION 8.8 • n=24 Participants
|
61.9 years
STANDARD_DEVIATION 11.7 • n=42 Participants
|
63.3 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
59.1 years
STANDARD_DEVIATION 10.3 • n=42 Participants
|
59.2 years
STANDARD_DEVIATION 12.1 • n=42 Participants
|
57.7 years
STANDARD_DEVIATION 11.8 • n=36 Participants
|
60.3 years
STANDARD_DEVIATION 10.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
325 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
114 Participants
n=8 Participants
|
102 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
52 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
57 Participants
n=36 Participants
|
835 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: After the first drug intake until 7 days after the last treatment administration, up to 383 daysPopulation: Treated patients
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
Outcome measures
| Measure |
Sulfonylurea: Empa 10mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
n=63 Participants
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
n=65 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha Glucosidase Inhibitor: Empa 10mg
n=69 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
Alpha Glucosidase Inhibitor: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
DPP-IV Inhibitor: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
DPP-IV Inhibitor: Empa 25mg
n=71 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
Glinide: Empa 10mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With Drug Related Adverse Events
|
19 participants
|
25 participants
|
13 participants
|
13 participants
|
9 participants
|
20 participants
|
19 participants
|
7 participants
|
5 participants
|
9 participants
|
18 participants
|
9 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: Full analysis set
Change from baseline in HbA1c after 52 weeks of treatment
Outcome measures
| Measure |
Sulfonylurea: Empa 10mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
n=63 Participants
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
n=65 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha Glucosidase Inhibitor: Empa 10mg
n=69 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
Alpha Glucosidase Inhibitor: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
DPP-IV Inhibitor: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
DPP-IV Inhibitor: Empa 25mg
n=71 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
Glinide: Empa 10mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c
|
-0.93 percentage of HbA1c
Standard Error 0.05
|
-0.96 percentage of HbA1c
Standard Error 0.05
|
-0.97 percentage of HbA1c
Standard Error 0.08
|
-0.81 percentage of HbA1c
Standard Error 0.06
|
-0.98 percentage of HbA1c
Standard Error 0.06
|
-0.90 percentage of HbA1c
Standard Error 0.05
|
-0.96 percentage of HbA1c
Standard Error 0.05
|
-0.87 percentage of HbA1c
Standard Error 0.06
|
-0.77 percentage of HbA1c
Standard Error 0.06
|
-1.00 percentage of HbA1c
Standard Error 0.06
|
-0.83 percentage of HbA1c
Standard Error 0.06
|
-0.98 percentage of HbA1c
Standard Error 0.08
|
-0.98 percentage of HbA1c
Standard Error 0.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After the first drug intake until 7 days after the last treatment administration, up to 383 daysPopulation: Treated patients
Number of patients with confirmed hypoglycaemic adverse events
Outcome measures
| Measure |
Sulfonylurea: Empa 10mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
n=63 Participants
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
n=65 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
n=137 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
n=136 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha Glucosidase Inhibitor: Empa 10mg
n=69 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
Alpha Glucosidase Inhibitor: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
|
DPP-IV Inhibitor: Empa 10mg
n=68 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
DPP-IV Inhibitor: Empa 25mg
n=71 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-IV inhibitor
|
Glinide: Empa 10mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
n=70 Participants
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Hypoglycaemic Adverse Events
|
6 participants
|
9 participants
|
5 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
Adverse Events
Sulfonylurea: Empa 10mg
Serious events: 10 serious events
Other events: 73 other events
Deaths: 0 deaths
Sulfonylurea: Empa 25mg
Serious events: 7 serious events
Other events: 74 other events
Deaths: 0 deaths
Sulfonylurea: Metformin
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Biguanide: Empa 10mg
Serious events: 7 serious events
Other events: 32 other events
Deaths: 0 deaths
Biguanide: Empa 25mg
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Thiazolidinedione: Empa 10mg
Serious events: 12 serious events
Other events: 77 other events
Deaths: 0 deaths
Thiazolidinedione: Empa 25mg
Serious events: 12 serious events
Other events: 74 other events
Deaths: 0 deaths
Alpha-GI: Empa 10mg
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Alpha-GI: Empa 25mg
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
DPP-4 Inhibitor: Empa 10mg
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
DPP-4 Inhibitor: Empa 25mg
Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths
Glinide: Empa 10mg
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Glinide: Empa 25mg
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sulfonylurea: Empa 10mg
n=136 participants at risk
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
n=137 participants at risk
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
n=63 participants at risk
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
n=68 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
n=65 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
n=137 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
n=136 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha-GI: Empa 10mg
n=69 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
|
Alpha-GI: Empa 25mg
n=70 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
|
DPP-4 Inhibitor: Empa 10mg
n=68 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
|
DPP-4 Inhibitor: Empa 25mg
n=71 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
|
Glinide: Empa 10mg
n=70 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
n=70 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Eye disorders
Cataract
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Eye disorders
Glaucoma
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Eye disorders
Retinal detachment
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Angina pectoris
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Vascular disorders
Artery dissection
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Megacolon
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
General disorders
Chest pain
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Febrile infection
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Gangrene
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.6%
1/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.6%
1/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.6%
1/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
Other adverse events
| Measure |
Sulfonylurea: Empa 10mg
n=136 participants at risk
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Empa 25mg
n=137 participants at risk
One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
|
Sulfonylurea: Metformin
n=63 participants at risk
250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
|
Biguanide: Empa 10mg
n=68 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Biguanide: Empa 25mg
n=65 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
|
Thiazolidinedione: Empa 10mg
n=137 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Thiazolidinedione: Empa 25mg
n=136 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
|
Alpha-GI: Empa 10mg
n=69 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
|
Alpha-GI: Empa 25mg
n=70 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
|
DPP-4 Inhibitor: Empa 10mg
n=68 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
|
DPP-4 Inhibitor: Empa 25mg
n=71 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
|
Glinide: Empa 10mg
n=70 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
Glinide: Empa 25mg
n=70 participants at risk
tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
30.1%
41/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
27.7%
38/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
41.3%
26/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
17.6%
12/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
35.4%
23/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
32.1%
44/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
27.2%
37/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
37.7%
26/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
30.0%
21/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
33.8%
23/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
21.1%
15/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
22.9%
16/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
24.3%
17/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Influenza
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.9%
5/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
3/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.1%
2/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.73%
1/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.2%
3/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Pharyngitis
|
2.2%
3/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.1%
7/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.2%
2/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
6/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
6/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.0%
5/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.1%
5/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
4/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Gastroenteritis
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
4/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.2%
2/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.1%
2/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
4/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.7%
4/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Infections and infestations
Bronchitis
|
5.1%
7/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
3/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.6%
3/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.7%
5/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.2%
3/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
8.1%
11/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
8.8%
12/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
9.5%
6/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.6%
3/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
4/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.2%
3/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Nervous system disorders
Dizziness
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.2%
2/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
4/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
4/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
4/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
3/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.8%
2/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
8.6%
6/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.1%
7/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
6/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
6.3%
4/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.6%
3/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.2%
3/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Constipation
|
3.7%
5/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.6%
5/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.2%
2/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
4/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.6%
3/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
6.6%
9/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.74%
1/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
11.4%
8/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.4%
5/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
9.9%
7/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.9%
5/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
8.8%
6/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
6.2%
4/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.6%
5/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.7%
4/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
3/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.2%
2/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
4/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.7%
4/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
3/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.1%
7/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.6%
1/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.7%
5/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.8%
8/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
8/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.0%
5/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.7%
4/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
3/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
6/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
8.0%
11/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.2%
3/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
4/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
9.9%
7/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.1%
5/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
General disorders
Thirst
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
4/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
4/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.4%
6/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
7.9%
5/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
6.6%
9/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
8/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.9%
4/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.6%
4/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
4.3%
3/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
2/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.2%
3/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
6.3%
4/63 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
0.00%
0/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
1/65 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.5%
2/137 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
3.7%
5/136 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/69 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.7%
4/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
2.9%
2/68 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
5.6%
4/71 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
1.4%
1/70 • After the first drug intake until 7 days after the last treatment administration, up to 383 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER