Trial Outcomes & Findings for Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes (NCT NCT01159600)
NCT ID: NCT01159600
Last Updated: 2014-06-17
Results Overview
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1504 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2014-06-17
Participant Flow
Participant milestones
| Measure |
Met: Placebo
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
207
|
217
|
214
|
69
|
225
|
226
|
218
|
103
|
|
Overall Study
COMPLETED
|
186
|
209
|
196
|
58
|
201
|
208
|
199
|
85
|
|
Overall Study
NOT COMPLETED
|
21
|
8
|
18
|
11
|
24
|
18
|
19
|
18
|
Reasons for withdrawal
| Measure |
Met: Placebo
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not treated
|
0
|
0
|
1
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Adverse Event
|
7
|
2
|
5
|
1
|
8
|
6
|
7
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Non compliant with protocol
|
2
|
1
|
0
|
0
|
2
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
4
|
3
|
3
|
0
|
3
|
2
|
|
Overall Study
Patient refusal to continue,not due toAE
|
7
|
2
|
4
|
5
|
4
|
4
|
2
|
5
|
|
Overall Study
Other reason not defined above
|
3
|
0
|
4
|
2
|
5
|
7
|
3
|
3
|
Baseline Characteristics
Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Met: Placebo
n=207 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=217 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=213 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=69 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=225 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=225 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=216 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=101 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Total
n=1473 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
56.9 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
57.0 years
STANDARD_DEVIATION 9.2 • n=8 Participants
|
57.4 years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
53.4 years
STANDARD_DEVIATION 10.5 • n=24 Participants
|
55.9 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
112 Participants
n=8 Participants
|
102 Participants
n=8 Participants
|
47 Participants
n=24 Participants
|
678 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
113 Participants
n=8 Participants
|
114 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
795 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: Full analysis set. Treatment assignment as randomised. Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Outcome measures
| Measure |
Met: Placebo
n=207 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=217 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=213 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=69 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=225 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=225 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=216 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=101 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline
|
-0.13 percentage of HbA1c
Standard Error 0.05
|
-0.70 percentage of HbA1c
Standard Error 0.05
|
-0.77 percentage of HbA1c
Standard Error 0.05
|
-2.78 percentage of HbA1c
Standard Error 0.21
|
-0.17 percentage of HbA1c
Standard Error 0.05
|
-0.82 percentage of HbA1c
Standard Error 0.05
|
-0.77 percentage of HbA1c
Standard Error 0.05
|
-2.53 percentage of HbA1c
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Full analysis set. Treatment assignment as randomised. Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Body weight change from baseline after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Outcome measures
| Measure |
Met: Placebo
n=207 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=217 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=213 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=69 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=225 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=225 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=216 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=101 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Body Weight Change From Baseline
|
-0.45 kg
Standard Error 0.17
|
-2.08 kg
Standard Error 0.17
|
-2.46 kg
Standard Error 0.17
|
-1.33 kg
Standard Error 0.43
|
-0.39 kg
Standard Error 0.15
|
-2.16 kg
Standard Error 0.15
|
-2.39 kg
Standard Error 0.16
|
-1.29 kg
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Full analysis set. Treatment assignment as randomised. Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.
Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
Outcome measures
| Measure |
Met: Placebo
n=133 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=148 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=147 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=43 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=151 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=148 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=117 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=52 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Mean Daily Plasma Glucose (MDG) Change From Baseline
|
-1.99 mg/dL
Standard Error 1.99
|
-9.64 mg/dL
Standard Error 1.89
|
-14.36 mg/dL
Standard Error 1.89
|
-35.47 mg/dL
Standard Error 7.34
|
0.00 mg/dL
Standard Error 1.78
|
-10.01 mg/dL
Standard Error 1.80
|
-13.06 mg/dL
Standard Error 2.03
|
-29.34 mg/dL
Standard Error 6.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 daysPopulation: Treated set, which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm.
Number of patients with confirmed hypoglycaemic events, as reported as adverse events.
Outcome measures
| Measure |
Met: Placebo
n=206 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=217 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=214 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=69 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=225 Participants
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=224 Participants
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=217 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=101 Participants
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Confirmed Hypoglycaemic Adverse Events
|
0.5 percentage of participants
0.01
|
1.8 percentage of participants
0.01
|
1.4 percentage of participants
0.03
|
2.9 percentage of participants
0.02
|
8.4 percentage of participants
0.01
|
16.1 percentage of participants
0.01
|
11.5 percentage of participants
0.03
|
6.9 percentage of participants
0.02
|
Adverse Events
Met: Placebo
Serious events: 7 serious events
Other events: 56 other events
Deaths: 0 deaths
Met: Empa 10mg
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Met: Empa 25mg
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Met: Empa 25mg Open Label
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Met+SU: Placebo
Serious events: 14 serious events
Other events: 76 other events
Deaths: 0 deaths
Met+SU: Empa 10mg
Serious events: 11 serious events
Other events: 77 other events
Deaths: 0 deaths
Met+SU: Empa 25mg
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Met+SU: Empa 25mg Open Label
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Met: Placebo
n=206 participants at risk
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=217 participants at risk
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=214 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=69 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=225 participants at risk
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=224 participants at risk
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=217 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=101 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.47%
1/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Anal abscess
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Cellulitis
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Sepsis
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.47%
1/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.47%
1/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Immune system disorders
Hypersensitivity
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.47%
1/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
General disorders
Non-cardiac chest pain
|
0.49%
1/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
1.4%
1/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.47%
1/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.47%
1/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.99%
1/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Listeria sepsis
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Pneumonia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.99%
1/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Endocrine disorders
Goitre
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Psychiatric disorders
Stress
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.46%
1/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Dizziness
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Syringomyelia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.99%
1/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.99%
1/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.89%
2/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
General disorders
Chest pain
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Investigations
Blood creatinine increased
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.44%
1/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.99%
1/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.45%
1/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
Other adverse events
| Measure |
Met: Placebo
n=206 participants at risk
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 10mg
n=217 participants at risk
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg
n=214 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met: Empa 25mg Open Label
n=69 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
|
Met+SU: Placebo
n=225 participants at risk
A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 10mg
n=224 participants at risk
Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg
n=217 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
Met+SU: Empa 25mg Open Label
n=101 participants at risk
Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.8%
16/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.5%
12/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
7.0%
15/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
7.2%
5/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
4.9%
11/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
8.0%
18/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
6.0%
13/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.0%
5/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Urinary tract infection
|
3.9%
8/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
4.1%
9/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
4.2%
9/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
7.2%
5/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
6.7%
15/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
9.4%
21/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
6.9%
15/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
3.0%
3/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Infections and infestations
Upper respiratory tract infections
|
4.4%
9/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.92%
2/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
4.2%
9/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.8%
4/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.3%
12/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
3.1%
7/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.1%
11/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
3.0%
3/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
9.8%
22/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
15.6%
35/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
12.9%
28/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
8.9%
9/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.2%
23/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
2.3%
5/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.93%
2/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
2.9%
2/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
12.4%
28/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
2.7%
6/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
2.3%
5/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
7.9%
8/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
7/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
1.8%
4/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
1.4%
3/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.8%
4/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
|
Nervous system disorders
Dizziness
|
0.00%
0/206 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/214 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
0.00%
0/69 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
5.3%
12/225 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
2.2%
5/224 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
4.1%
9/217 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
2.0%
2/101 • From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days
Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken. Open label set which included all patients entered into the open-label arm
|
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