Trial Outcomes & Findings for Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI) (NCT NCT02164864)
NCT ID: NCT02164864
Last Updated: 2018-07-31
Results Overview
Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2725 participants
Primary outcome timeframe
up to 30 months
Results posted on
2018-07-31
Participant Flow
Patients aged ≥80 years in the United States of America (USA) were assigned to 110 milligram (mg) Dual antithrombotic therapy with dabigatran etexilate (DE-DAT), 150 mg DE-DAT, or warfarin. All other patients including aged ≥80 years (for Japan ≥70 years) outside of the USA were assigned to 110 mg DE-DAT or warfarin
All patients (Pts) were screened for eligibility to participate in trial. Pts attended sites to ensure that they met all implemented inclusion/exclusion criteria. Pts were not to be randomised to trial drug if any of specific entry criteria was violated. In this study, 2725 Pts were entered \& randomised. 2678 Pts were treated.
Participant milestones
| Measure |
Dabigatran Etexilate 110mg
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
|---|---|---|---|
|
Overall Study
STARTED
|
981
|
763
|
981
|
|
Overall Study
COMPLETED
|
886
|
703
|
849
|
|
Overall Study
NOT COMPLETED
|
95
|
60
|
132
|
Reasons for withdrawal
| Measure |
Dabigatran Etexilate 110mg
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
|---|---|---|---|
|
Overall Study
Trial disease worsening
|
7
|
5
|
1
|
|
Overall Study
Other pre-existing disease worsening
|
6
|
4
|
9
|
|
Overall Study
Other Adverse Event (AE)
|
52
|
32
|
49
|
|
Overall Study
Protocol Violation
|
2
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
2
|
|
Overall Study
Consent withdrawn, not due to AE
|
21
|
8
|
56
|
|
Overall Study
Other than stated
|
3
|
4
|
14
|
Baseline Characteristics
FAS
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Total
n=2725 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.5 Years
STANDARD_DEVIATION 8.87 • n=5 Participants • FAS
|
68.6 Years
STANDARD_DEVIATION 7.65 • n=7 Participants • FAS
|
71.7 Years
STANDARD_DEVIATION 8.90 • n=5 Participants • FAS
|
70.8 Years
STANDARD_DEVIATION 8.66 • n=4 Participants • FAS
|
|
Age, Customized
<80: EU/ROW
|
725 Participants
n=5 Participants
|
699 Participants
n=7 Participants
|
718 Participants
n=5 Participants
|
2142 Participants
n=4 Participants
|
|
Age, Customized
<80: USA
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Age, Customized
≥80: EU/ROW
|
189 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
384 Participants
n=4 Participants
|
|
Age, Customized
≥80: USA
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
253 Participants
n=5 Participants • FAS
|
171 Participants
n=7 Participants • FAS
|
231 Participants
n=5 Participants • FAS
|
655 Participants
n=4 Participants • FAS
|
|
Sex: Female, Male
Male
|
728 Participants
n=5 Participants • FAS
|
592 Participants
n=7 Participants • FAS
|
750 Participants
n=5 Participants • FAS
|
2070 Participants
n=4 Participants • FAS
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=5 Participants • FAS
|
46 Participants
n=7 Participants • FAS
|
59 Participants
n=5 Participants • FAS
|
175 Participants
n=4 Participants • FAS
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
903 Participants
n=5 Participants • FAS
|
700 Participants
n=7 Participants • FAS
|
904 Participants
n=5 Participants • FAS
|
2507 Participants
n=4 Participants • FAS
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants • FAS
|
17 Participants
n=7 Participants • FAS
|
18 Participants
n=5 Participants • FAS
|
43 Participants
n=4 Participants • FAS
|
|
Race/Ethnicity, Customized
Asian
|
116 Participants
n=5 Participants • FAS
|
79 Participants
n=7 Participants • FAS
|
125 Participants
n=5 Participants • FAS
|
320 Participants
n=4 Participants • FAS
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants • FAS
|
7 Participants
n=7 Participants • FAS
|
3 Participants
n=5 Participants • FAS
|
15 Participants
n=4 Participants • FAS
|
|
Race/Ethnicity, Customized
White
|
851 Participants
n=5 Participants • FAS
|
658 Participants
n=7 Participants • FAS
|
835 Participants
n=5 Participants • FAS
|
2344 Participants
n=4 Participants • FAS
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants • FAS
|
8 Participants
n=7 Participants • FAS
|
7 Participants
n=5 Participants • FAS
|
20 Participants
n=4 Participants • FAS
|
|
Race/Ethnicity, Customized
Missing
|
4 Participants
n=5 Participants • FAS
|
11 Participants
n=7 Participants • FAS
|
11 Participants
n=5 Participants • FAS
|
26 Participants
n=4 Participants • FAS
|
PRIMARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to First Adjudicated ISTH MBE or CRNMBE
|
151 Participants
|
154 Participants
|
264 Participants
|
196 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Adjudicated Undetermined Cause of Death
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported. Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Adjudicated Non-CV
|
14 Participants
|
4 Participants
|
13 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported. CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Adjudicated CV
|
37 Participants
|
21 Participants
|
31 Participants
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Adjudicated All Cause Death
|
55 Participants
|
30 Participants
|
48 Participants
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to First Adjudicated MI
|
44 Participants
|
26 Participants
|
29 Participants
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to First Adjudicated Stroke
|
17 Participants
|
9 Participants
|
13 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported. SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to First Adjudicated SE
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to First Adjudicated ST
|
15 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Composite Endpoint of Death + MI + Stroke
|
107 Participants
|
60 Participants
|
80 Participants
|
57 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
n=1744 Participants
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Composite Endpoint of Death or First Thrombotic Event
|
108 Participants
|
60 Participants
|
83 Participants
|
60 Participants
|
168 Participants
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
|
76 Participants
|
51 Participants
|
69 Participants
|
52 Participants
|
—
|
SECONDARY outcome
Timeframe: up to 30 monthsPopulation: Full Analysis set (FAS) following the intention-to-treat principle.
Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.
Outcome measures
| Measure |
Dabigatran Etexilate 110mg
n=981 Participants
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=763 Participants
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=981 Participants
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
Warfarin (Excluding Elder Patients Outside USA)
n=764 Participants
Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.
|
All Dabigatran Etexilate
n=1744 Participants
Patients in combined Dabigatran Etexilate group (ie 110 mg DE + 150 mg DE).
|
|---|---|---|---|---|---|
|
Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
|
149 Participants
|
90 Participants
|
131 Participants
|
98 Participants
|
239 Participants
|
Adverse Events
Dabigatran Etexilate 110mg
Serious events: 415 serious events
Other events: 128 other events
Deaths: 38 deaths
Dabigatran Etexilate 150mg
Serious events: 300 serious events
Other events: 126 other events
Deaths: 24 deaths
Warfarin
Serious events: 396 serious events
Other events: 229 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Dabigatran Etexilate 110mg
n=972 participants at risk
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=758 participants at risk
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=948 participants at risk
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
6/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.92%
7/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.74%
7/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Acute coronary syndrome
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Acute left ventricular failure
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Acute myocardial infarction
|
2.1%
20/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.8%
14/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.6%
15/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Acute right ventricular failure
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Angina pectoris
|
2.1%
20/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
2.4%
18/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.9%
18/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Angina unstable
|
2.7%
26/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
2.0%
15/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.4%
13/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Aortic valve stenosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Arrhythmia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
44/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
4.7%
36/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
3.6%
34/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Atrial flutter
|
1.9%
18/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.1%
8/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.63%
6/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Atrial tachycardia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Atrial thrombosis
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Bradycardia
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.63%
6/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac arrest
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac failure
|
4.9%
48/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
4.0%
30/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
4.9%
46/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac failure acute
|
0.72%
7/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac failure chronic
|
0.72%
7/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
14/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.7%
13/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
2.0%
19/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Coronary artery disease
|
0.62%
6/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.79%
6/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.74%
7/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Coronary artery stenosis
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.6%
12/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Intracardiac thrombus
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Left ventricular failure
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Mitral valve incompetence
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
17/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.1%
8/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.84%
8/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Myocardial ischaemia
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Palpitations
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Pericardial effusion
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Pericarditis constrictive
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Sinus bradycardia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Sinus node dysfunction
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Tachyarrhythmia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Tachycardia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Ventricle rupture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Ventricular fibrillation
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Cardiac disorders
Ventricular tachycardia
|
0.72%
7/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Congenital, familial and genetic disorders
Generalised resistance to thyroid hormone
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Congenital, familial and genetic disorders
Venous angioma of brain
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Ear and labyrinth disorders
Deafness
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Ear and labyrinth disorders
Vertigo
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Endocrine disorders
Thyroid mass
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Blindness transient
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Cataract
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Glaucoma
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Retinal detachment
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Colitis
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Dysphagia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.93%
9/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.4%
13/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Haematemesis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Haematochezia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Melaena
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Nausea
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Stomach mass
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Adverse drug reaction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Asthenia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Cardiac death
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Chest discomfort
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Chest pain
|
1.4%
14/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
2.0%
15/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.6%
15/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Death
|
0.82%
8/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.79%
6/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Device related thrombosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Drug effect increased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Gait disturbance
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
General physical health deterioration
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Impaired healing
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Implant site haematoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Injection site haematoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Localised oedema
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Malaise
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Medical device site haematoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Non-cardiac chest pain
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Oedema
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Oedema peripheral
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Pyrexia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Sudden cardiac death
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Sudden death
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.74%
7/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Ulcer
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Vascular stent restenosis
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Vascular stent stenosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
General disorders
Vascular stent thrombosis
|
2.6%
25/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.3%
10/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.8%
17/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Cholecystitis
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Hepatic failure
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Anal abscess
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Appendicitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Bone abscess
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Bronchitis
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Candida infection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Cellulitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.79%
6/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Dengue fever
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Device related infection
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Empyema
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Endocarditis
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Epididymitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Erysipelas
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Escherichia sepsis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Gangrene
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Gastritis viral
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Infected cyst
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Infection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Influenza
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Liver abscess
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Lower respiratory tract infection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Lung infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Orchitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Osteomyelitis
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pneumonia
|
2.1%
20/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
2.0%
15/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
2.0%
19/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Renal abscess
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Respiratory tract infection
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Respiratory tract infection viral
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Scrotal abscess
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Sepsis
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Septic shock
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Skin bacterial infection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Soft tissue infection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Systemic infection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Urinary tract infection
|
0.62%
6/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Urosepsis
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Vestibular neuronitis
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Infections and infestations
Viral infection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Concussion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Head injury
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Iatrogenic injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Laceration
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Wound
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Blood creatinine increased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Blood pressure increased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Blood urine
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Blood urine present
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
C-reactive protein increased
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Haematocrit decreased
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
International normalised ratio increased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.95%
9/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Liver function test increased
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Occult blood positive
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Investigations
Troponin increased
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.72%
7/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Plica syndrome
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of penis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage I
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer recurrent
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.62%
6/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage 0
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular neoplasm
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary bladder adenoma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Altered state of consciousness
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Basal ganglia stroke
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Brain injury
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Brain oedema
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Brain stem infarction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Carotid artery occlusion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Carotid artery stenosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Cerebral infarction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.42%
4/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Dementia
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Diplegia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Dizziness
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Encephalomalacia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Epilepsy
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Headache
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Ischaemic stroke
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Lacunar infarction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Lateral medullary syndrome
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Mental impairment
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Migraine
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Sciatica
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Seizure
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Somnolence
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Syncope
|
0.93%
9/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.3%
10/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.74%
7/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Tension headache
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Nervous system disorders
Transient ischaemic attack
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Product Issues
Device malfunction
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Anxiety
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Delirium
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Hallucination, visual
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Mental status changes
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Paranoia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Psychiatric disorders
Transient psychosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
15/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.8%
14/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.63%
6/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Haematuria
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.74%
7/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Renal failure
|
0.62%
6/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Renal impairment
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Reproductive system and breast disorders
Prostatitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.79%
6/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.63%
6/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
11/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.3%
10/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.8%
17/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.95%
9/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.41%
4/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.82%
8/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.32%
3/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.72%
7/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
4/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aneurysm
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Angiodysplasia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortic dissection
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortic dissection rupture
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortic necrosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortic stenosis
|
0.31%
3/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Aortitis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Extremity necrosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Haematoma
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.74%
7/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Haemorrhage
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.63%
6/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Hypertension
|
0.62%
6/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.66%
5/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Hypertensive crisis
|
0.82%
8/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.40%
3/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
1.2%
11/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Hypertensive emergency
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Hypotension
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.63%
6/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Iliac artery occlusion
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Intermittent claudication
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Ischaemia
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.51%
5/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.13%
1/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.53%
5/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.21%
2/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Peripheral artery stenosis
|
0.10%
1/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Peripheral embolism
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.26%
2/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Shock
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Thrombosis
|
0.21%
2/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.00%
0/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
0.11%
1/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
Other adverse events
| Measure |
Dabigatran Etexilate 110mg
n=972 participants at risk
Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
|
Dabigatran Etexilate 150mg
n=758 participants at risk
Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
|
Warfarin
n=948 participants at risk
Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.4%
62/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
7.9%
60/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
6.4%
61/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
52/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
7.8%
59/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
15.4%
146/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
|
Vascular disorders
Haematoma
|
2.8%
27/972 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
3.2%
24/758 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
6.3%
60/948 • From the first intake of randomised trial drug until 6 days after the last intake of the randomised trial drug, ie., up to 31 Months.
Treated set (TS): The set of patients who received at least 1 dose of trial medication was analysed according to the treatment they had received. The start date of the observation period for this analysis set was the date of the first intake of trial medication. All on-treatement AE's for this study were reported based on the Treated set
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER