Trial Outcomes & Findings for Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients (NCT NCT00701714)
NCT ID: NCT00701714
Last Updated: 2018-02-05
Results Overview
Mean absolute change in hemoglobin (baseline to end of study week 13)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
337 participants
Primary outcome timeframe
13 weeks
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
HX575, EPO HEXAL
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
ERYPO
ERYPO: Solution for injection (s.c.)
|
|---|---|---|
|
Treatment Period (up to 1 Year)
STARTED
|
174
|
163
|
|
Treatment Period (up to 1 Year)
COMPLETED
|
37
|
29
|
|
Treatment Period (up to 1 Year)
NOT COMPLETED
|
137
|
134
|
|
Safety Follow-up Period (6 Months)
STARTED
|
151
|
119
|
|
Safety Follow-up Period (6 Months)
COMPLETED
|
144
|
112
|
|
Safety Follow-up Period (6 Months)
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
Baseline characteristics by cohort
| Measure |
Treatmen HX575 EPO HEXAL
n=174 Participants
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
Treatment ERYPO
n=163 Participants
ERYPO: Solution for injection (s.c.)
|
Total
n=337 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 14.4 • n=93 Participants
|
64.9 years
STANDARD_DEVIATION 15 • n=4 Participants
|
64.5 years
STANDARD_DEVIATION 14.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=93 Participants
|
155 Participants
n=4 Participants
|
322 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
22 participants
n=93 Participants
|
19 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Region of Enrollment
Russian Federation
|
29 participants
n=93 Participants
|
24 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Region of Enrollment
Romania
|
47 participants
n=93 Participants
|
52 participants
n=4 Participants
|
99 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
13 participants
n=93 Participants
|
14 participants
n=4 Participants
|
27 participants
n=27 Participants
|
|
Region of Enrollment
Slovakia
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Bulgaria
|
4 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
Region of Enrollment
France
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
45 participants
n=93 Participants
|
39 participants
n=4 Participants
|
84 participants
n=27 Participants
|
|
Region of Enrollment
India
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: Full analysis set required: "all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available". 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.
Mean absolute change in hemoglobin (baseline to end of study week 13)
Outcome measures
| Measure |
HX575, EPO HEXAL
n=171 Participants
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
ERYPO
n=157 Participants
ERYPO: Solution for injection (s.c.)
|
|---|---|---|
|
Change in Hemoglobin Level
|
2.2 g/dL
Standard Deviation 1.0
|
2.1 g/dL
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: weeks 11-13Population: Full analysis set required: "all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available". 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.
Mean weekly epoetin dose \[IU/kg\] in study weeks 11-13
Outcome measures
| Measure |
HX575, EPO HEXAL
n=171 Participants
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
ERYPO
n=157 Participants
ERYPO: Solution for injection (s.c.)
|
|---|---|---|
|
Weekly Epoetin Dose
|
55.1 IU/kg
Standard Deviation 41.9
|
57.9 IU/kg
Standard Deviation 46.6
|
SECONDARY outcome
Timeframe: 13 weeksNumber of participants with antibody formation against Epoetin during treatment period (safety set)
Outcome measures
| Measure |
HX575, EPO HEXAL
n=174 Participants
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
ERYPO
n=163 Participants
ERYPO: Solution for injection (s.c.)
|
|---|---|---|
|
Immunogenicity
|
5 participants
|
2 participants
|
Adverse Events
Treatment HX575, EPO HEXAL
Serious events: 50 serious events
Other events: 137 other events
Deaths: 6 deaths
Treatment ERYPO
Serious events: 70 serious events
Other events: 132 other events
Deaths: 14 deaths
Safety Follow-up HX575, EPO HEXAL
Serious events: 22 serious events
Other events: 87 other events
Deaths: 2 deaths
Safety Follow-up ERYPO
Serious events: 24 serious events
Other events: 58 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment HX575, EPO HEXAL
n=174 participants at risk
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
Treatment ERYPO
n=163 participants at risk
ERYPO: Solution for injection (s.c.)
|
Safety Follow-up HX575, EPO HEXAL
n=151 participants at risk
Patients received HX575, EPO HEXAL during Treatment Period
|
Safety Follow-up ERYPO
n=119 participants at risk
Patients received ERYPO during Treatment Period
|
|---|---|---|---|---|
|
Renal and urinary disorders
Renal failure chronic
|
6.9%
12/174 • Number of events 13 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
13.5%
22/163 • Number of events 22 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
7.3%
11/151 • Number of events 11 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
8.4%
10/119 • Number of events 10 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal failure
|
4.0%
7/174 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.7%
6/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
4.3%
7/163 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Azotaemia
|
1.7%
3/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.8%
3/163 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Anuria
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Cardiac failure
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.8%
3/163 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Myocardial infarction
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Acute coronary syndrome
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Acute myocardial infarction
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Cardiogenic shock
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Tachyarrhythmia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Pneumonia
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Bronchopneumonia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Lung infection
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Bacterial infection
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Bronchitis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Cellulitis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Febrile infection
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Gastroenteritis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Hepatitis C
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Pharyngitis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Pneumonia bacterial
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Respiratory tract infection viral
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Tracheobronchitis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Urinary tract infection
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Ascites
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Gastritis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Duodenitis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Dyspepsia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Enteritis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Pancreatitis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.8%
3/163 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.7%
3/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.57%
1/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Oedema
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Oedema peripheral
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Chest pain
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
General physical health deterioration
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Generalised oedema
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Inflammation
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Hypertrophy
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Necrosis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Pyrexia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Sudden death
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.8%
3/163 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Syncope
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Transient ischaemic attack
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Coma
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Hypertension
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Hypertensive crisis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Circulatory collapse
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Deep vein thrombosis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Gangrene
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Steal syndrome
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Concussion
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.57%
1/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage II
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Anti-erythropoietin antibody positive
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Blood creatine increased
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Blood creatinine increased
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Blood potassium increased
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Eye disorders
Diabetic retinopathy
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Immune system disorders
Hypersensitivity
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Catheter sepsis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Sepsis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Hypotension
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Shock
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Headache
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/174 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
Other adverse events
| Measure |
Treatment HX575, EPO HEXAL
n=174 participants at risk
HX575 recombinant human erythropoietin alfa: Solution for injection (s.c.)
|
Treatment ERYPO
n=163 participants at risk
ERYPO: Solution for injection (s.c.)
|
Safety Follow-up HX575, EPO HEXAL
n=151 participants at risk
Patients received HX575, EPO HEXAL during Treatment Period
|
Safety Follow-up ERYPO
n=119 participants at risk
Patients received ERYPO during Treatment Period
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.8%
17/174 • Number of events 23 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
8.6%
14/163 • Number of events 17 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.3%
5/151 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Urinary tract infection
|
9.2%
16/174 • Number of events 21 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
7.4%
12/163 • Number of events 14 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.3%
5/151 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
5.0%
6/119 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Oedema peripheral
|
12.1%
21/174 • Number of events 28 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
10.4%
17/163 • Number of events 22 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.6%
4/151 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Fatigue
|
5.7%
10/174 • Number of events 13 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.0%
3/151 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Bronchitis
|
4.6%
8/174 • Number of events 10 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
5.5%
9/163 • Number of events 10 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.0%
3/151 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Hypertension
|
21.8%
38/174 • Number of events 73 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
25.2%
41/163 • Number of events 88 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
6.6%
10/151 • Number of events 14 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
8.4%
10/119 • Number of events 11 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal failure chronic
|
7.5%
13/174 • Number of events 16 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
14.7%
24/163 • Number of events 24 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
8.6%
13/151 • Number of events 13 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
9.2%
11/119 • Number of events 13 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal impairment
|
1.7%
3/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
5.5%
9/163 • Number of events 9 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
3/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
6.7%
11/163 • Number of events 13 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Pneumonia
|
2.3%
4/174 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
3/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.1%
5/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Vascular disorders
Hypotension
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.7%
6/163 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Renal and urinary disorders
Renal failure
|
4.0%
7/174 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.7%
6/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.0%
3/151 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Oedema
|
1.7%
3/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.1%
5/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Pyrexia
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.7%
6/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
General disorders
Asthenia
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
7/174 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.7%
6/163 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.6%
4/151 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
3/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
4.9%
8/163 • Number of events 9 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Nausea
|
3.4%
6/174 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
4/174 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.1%
5/163 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
3/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.1%
5/163 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Gastrointestinal disorders
Constipation
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Cardiac failure
|
2.9%
5/174 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.1%
5/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
4/174 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.8%
3/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
3/174 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.3%
5/151 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Dizziness
|
4.0%
7/174 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Nervous system disorders
Headache
|
4.0%
7/174 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.7%
6/163 • Number of events 6 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 3 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
2/174 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/151 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.3%
2/151 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Blood pressure increased
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.5%
4/163 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.84%
1/119 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Anti-erythropoietin antibody positive
|
2.9%
5/174 • Number of events 7 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.3%
5/151 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.3%
4/174 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/163 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
2.6%
4/151 • Number of events 4 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
5/174 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.2%
2/163 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.66%
1/151 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.00%
0/119 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.57%
1/174 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
0.61%
1/163 • Number of events 1 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
3.3%
5/151 • Number of events 5 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
1.7%
2/119 • Number of events 2 • Treatment period: up to 1 year; Safety follow up period: 6 months
Safety Population (SAF) was composed of all patients who received at least one dose of the study medication during treatment period
|
Additional Information
Biopharmaceutical Clinical Development, Strategic Planning
Sandoz
Phone: 0049 80244760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
- Publication restrictions are in place
Restriction type: OTHER