Trial Outcomes & Findings for Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus (NCT NCT01193218)
NCT ID: NCT01193218
Last Updated: 2014-06-17
Results Overview
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
547 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2014-06-17
Participant Flow
Participant milestones
| Measure |
Placebo/Empa 10mg
It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
|
Placebo/Empa 25 mg
It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
|
Empa 5mg/10mg
It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
|
Empa 5 mg/25 mg
It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
|
Empa 10mg
Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
|
Empa 25mg
Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
|
Empa 50mg\10mg
It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
|
Empa 50 mg/25 mg
It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
|
|---|---|---|---|---|---|---|---|---|
|
0-12 Weeks
STARTED
|
109
|
0
|
110
|
0
|
109
|
109
|
110
|
0
|
|
0-12 Weeks
COMPLETED
|
100
|
0
|
107
|
0
|
108
|
106
|
107
|
0
|
|
0-12 Weeks
NOT COMPLETED
|
9
|
0
|
3
|
0
|
1
|
3
|
3
|
0
|
|
12-52 Weeks
STARTED
|
50
|
50
|
54
|
53
|
108
|
106
|
54
|
53
|
|
12-52 Weeks
COMPLETED
|
45
|
50
|
50
|
50
|
104
|
101
|
51
|
49
|
|
12-52 Weeks
NOT COMPLETED
|
5
|
0
|
4
|
3
|
4
|
5
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo/Empa 10mg
It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
|
Placebo/Empa 25 mg
It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
|
Empa 5mg/10mg
It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
|
Empa 5 mg/25 mg
It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
|
Empa 10mg
Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
|
Empa 25mg
Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
|
Empa 50mg\10mg
It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
|
Empa 50 mg/25 mg
It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
|
|---|---|---|---|---|---|---|---|---|
|
0-12 Weeks
Adverse Event
|
6
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
|
0-12 Weeks
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
0-12 Weeks
Withdrawal by Subject
|
3
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
|
12-52 Weeks
Adverse Event
|
1
|
0
|
1
|
2
|
3
|
3
|
1
|
2
|
|
12-52 Weeks
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
12-52 Weeks
Withdrawal by Subject
|
3
|
0
|
3
|
0
|
0
|
2
|
1
|
2
|
|
12-52 Weeks
Other reason than above
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo (12 Week)
n=109 Participants
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=110 Participants
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=109 Participants
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=109 Participants
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=110 Participants
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
56.6 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
57.5 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
137 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
410 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS)
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
Outcome measures
| Measure |
Placebo (12 Week)
n=109 Participants
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=110 Participants
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=109 Participants
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=109 Participants
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=110 Participants
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in HbA1c After 12 Weeks of Treatment.
|
0.30 percentage of HbA1c
Standard Error 0.09
|
-0.42 percentage of HbA1c
Standard Error 0.09
|
-0.40 percentage of HbA1c
Standard Error 0.09
|
-0.65 percentage of HbA1c
Standard Error 0.09
|
-0.61 percentage of HbA1c
Standard Error 0.09
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS)
Occurrence of treat to target efficacy response, that is an HbA1c of \<7.0% after 12 weeks of treatment
Outcome measures
| Measure |
Placebo (12 Week)
n=106 Participants
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=107 Participants
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=105 Participants
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=106 Participants
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=107 Participants
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
|---|---|---|---|---|---|
|
Occurrence of Treat to Target Efficacy Response
|
2.8 percentage of participants
Interval 0.6 to 8.0
|
26.2 percentage of participants
Interval 18.1 to 35.6
|
19.0 percentage of participants
Interval 12.0 to 27.9
|
32.1 percentage of participants
Interval 23.3 to 41.8
|
32.7 percentage of participants
Interval 24.0 to 42.5
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Full analysis set (FAS)
Change from baseline in FPG after 12 weeks of treatment
Outcome measures
| Measure |
Placebo (12 Week)
n=109 Participants
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=110 Participants
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=109 Participants
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=109 Participants
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=110 Participants
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
|---|---|---|---|---|---|
|
Change From Baseline in FPG
|
4.06 mg/dL
Standard Error 2.88
|
-22.65 mg/dL
Standard Error 2.97
|
-25.28 mg/dL
Standard Error 2.77
|
-33.70 mg/dL
Standard Error 2.92
|
-32.54 mg/dL
Standard Error 2.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 daysPopulation: Treated patients
Number of patients with confirmed hypoglycaemic adverse events
Outcome measures
| Measure |
Placebo (12 Week)
n=109 Participants
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=110 Participants
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=109 Participants
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=109 Participants
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=110 Participants
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
|---|---|---|---|---|---|
|
Confirmed Hypoglycaemic Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
Adverse Events
Placebo (12 Week)
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Empa 5mg (12 Week)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Empa 10mg (12 Week)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Empa 25mg (12 Week)
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Empa 50mg (12 Week)
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Empa 10mg (Randomized, 52 Week)
Serious events: 3 serious events
Other events: 39 other events
Deaths: 0 deaths
Empa 25mg (Randomized, 52 Week)
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Empa 10mg (With at Least One Dose, 52 Week)
Serious events: 8 serious events
Other events: 83 other events
Deaths: 0 deaths
Empa 25mg (With at Least One Dose, 52 Week)
Serious events: 15 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (12 Week)
n=109 participants at risk
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=110 participants at risk
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=109 participants at risk
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=109 participants at risk
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=110 participants at risk
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
Empa 10mg (Randomized, 52 Week)
n=109 participants at risk
Patients randomized to empagliflozin 10mg once daily for 52 weeks
|
Empa 25mg (Randomized, 52 Week)
n=109 participants at risk
Patients randomized to empagliflozin 25 mg once daily for 52 weeks
|
Empa 10mg (With at Least One Dose, 52 Week)
n=267 participants at risk
Patients with at least one dose of empagliflozin 10 mg once daily for 52-week treatment
|
Empa 25mg (With at Least One Dose, 52 Week)
n=265 participants at risk
Patients with at least one dose of empagliflozin 25 mg once daily for 52-week treatment
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Infections and infestations
Viral infection
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone marrow
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Eye disorders
Glaucoma
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Eye disorders
Macular hole
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.91%
1/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
General disorders
Device dislocation
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
General disorders
Pyrexia
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.37%
1/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.38%
1/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
Other adverse events
| Measure |
Placebo (12 Week)
n=109 participants at risk
Placebo once daily group in the 12-week first treatment period
|
Empa 5mg (12 Week)
n=110 participants at risk
Empagliflozin 5 mg once daily group in the 12-week first treatment period
|
Empa 10mg (12 Week)
n=109 participants at risk
Empagliflozin 10 mg once daily group in the 12-week first treatment period
|
Empa 25mg (12 Week)
n=109 participants at risk
Empagliflozin 25 mg once daily group in the 12-week first treatment period
|
Empa 50mg (12 Week)
n=110 participants at risk
Empagliflozin 50 mg once daily group in the 12-week first treatment period
|
Empa 10mg (Randomized, 52 Week)
n=109 participants at risk
Patients randomized to empagliflozin 10mg once daily for 52 weeks
|
Empa 25mg (Randomized, 52 Week)
n=109 participants at risk
Patients randomized to empagliflozin 25 mg once daily for 52 weeks
|
Empa 10mg (With at Least One Dose, 52 Week)
n=267 participants at risk
Patients with at least one dose of empagliflozin 10 mg once daily for 52-week treatment
|
Empa 25mg (With at Least One Dose, 52 Week)
n=265 participants at risk
Patients with at least one dose of empagliflozin 25 mg once daily for 52-week treatment
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.2%
10/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
7.3%
8/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
8.3%
9/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
10.1%
11/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
10.0%
11/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
27.5%
30/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
30.3%
33/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
23.2%
62/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
23.8%
63/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Infections and infestations
Pharyngitis
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.7%
4/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
2.8%
3/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
1.8%
2/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
5.5%
6/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
5.5%
6/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
4.1%
11/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.4%
9/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Gastrointestinal disorders
Constipation
|
2.8%
3/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
1.8%
2/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.7%
4/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
1.8%
2/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
5.5%
6/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
1.1%
3/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.8%
10/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.91%
1/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
6.4%
7/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.75%
2/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.4%
9/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.6%
4/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.00%
0/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.7%
4/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.7%
4/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
5.2%
14/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.8%
10/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.6%
4/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
6.4%
7/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
5.5%
6/110 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
0.92%
1/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
7.3%
8/109 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
1.5%
4/267 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
|
3.8%
10/265 • between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 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