Trial Outcomes & Findings for The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis (NCT NCT00503698)
NCT ID: NCT00503698
Last Updated: 2017-03-07
Results Overview
Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
712 participants
Primary outcome timeframe
week 0, trial termination
Results posted on
2017-03-07
Participant Flow
A total of 202 sites in 17 countries: United States, Canada, United Kingdom, Sweden, Denmark, France, Germany, Poland, Hungary, Spain, Portugal, Turkey, Israel, Argentina, Brazil, Russia, South Africa. Italy planned to participate but never randomised any subjects.
Subjects who were malnourished (based on serum albumin value below 40 g/L, assessed centrally) and had received adequate haemodialysis treatment for more than three months at time of trial entry, were eligible.
Participant milestones
| Measure |
Somatropin
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Overall Study
STARTED
|
357
|
355
|
|
Overall Study
Exposed to Trial Drug
|
346
|
349
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
357
|
355
|
Reasons for withdrawal
| Measure |
Somatropin
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
6
|
|
Overall Study
Adverse Event
|
52
|
41
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
4
|
|
Overall Study
Trial terminated
|
216
|
253
|
|
Overall Study
End hemodialysis due to renal transplant
|
10
|
4
|
|
Overall Study
Pregnancy/intention to become pregnant
|
1
|
0
|
|
Overall Study
Any condition in exclusion criteria
|
4
|
6
|
|
Overall Study
Switch to peritoneal or home dialysis
|
2
|
2
|
|
Overall Study
Move to nonparticipating dialysis center
|
2
|
1
|
|
Overall Study
Critically ill
|
2
|
0
|
|
Overall Study
Unclassified
|
48
|
32
|
|
Overall Study
Not exposed to trial drug
|
11
|
6
|
Baseline Characteristics
The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis
Baseline characteristics by cohort
| Measure |
Somatropin
n=346 Participants
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 Participants
Placebo once daily, week 0 to end of trial
|
Total
n=695 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
175 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
286 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
565 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
114 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
205 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Diabetes
Type 1 diabetes mellitus
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Diabetes
Type 2 diabetes mellitus
|
161 participants
n=5 Participants
|
150 participants
n=7 Participants
|
311 participants
n=5 Participants
|
|
Diabetes
Not Diabetic
|
173 participants
n=5 Participants
|
183 participants
n=7 Participants
|
356 participants
n=5 Participants
|
|
BMI
|
28.9 kg/m2
STANDARD_DEVIATION 8.6 • n=5 Participants
|
28.4 kg/m2
STANDARD_DEVIATION 8.0 • n=7 Participants
|
28.7 kg/m2
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Duration of Diabetes
|
17.5 years
n=5 Participants
|
20.3 years
n=7 Participants
|
18.4 years
n=5 Participants
|
|
Duration of Dialysis
|
2.9 years
n=5 Participants
|
2.9 years
n=7 Participants
|
2.9 years
n=5 Participants
|
|
Height
|
167.1 cm
STANDARD_DEVIATION 11.2 • n=5 Participants
|
168.1 cm
STANDARD_DEVIATION 10.4 • n=7 Participants
|
167.6 cm
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Weight
|
80.6 kg
STANDARD_DEVIATION 24.3 • n=5 Participants
|
80.6 kg
STANDARD_DEVIATION 25.0 • n=7 Participants
|
80.6 kg
STANDARD_DEVIATION 24.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 0, trial terminationPopulation: FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).
Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.
Outcome measures
| Measure |
Somatropin
n=346 Participants
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 Participants
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Mortality - Time to All-cause Death
Baseline (week 0)
|
0 percentage of participants
NA
|
0 percentage of participants
NA
|
|
Mortality - Time to All-cause Death
Week 26
|
8 percentage of participants
|
8 percentage of participants
|
|
Mortality - Time to All-cause Death
Week 44
|
13 percentage of participants
|
17 percentage of participants
|
|
Mortality - Time to All-cause Death
Week 52
|
29 percentage of participants
|
23 percentage of participants
|
SECONDARY outcome
Timeframe: week 0, trial terminationPopulation: FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 (end of trial per protocol).
Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.
Outcome measures
| Measure |
Somatropin
n=346 Participants
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 Participants
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)
Baseline (week 0)
|
0 percentage of participants
0
|
0 percentage of participants
0
|
|
Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)
Week 26
|
12 percentage of participants
|
17 percentage of participants
|
|
Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)
Week 40
|
18 percentage of participants
|
23 percentage of participants
|
|
Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)
Week 52
|
31 percentage of participants
|
24 percentage of participants
|
SECONDARY outcome
Timeframe: week 0, trial terminationPopulation: FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Due to the early termination of this trial, observations from end of trial visit are substituted for week 104 visit (end of trial as per protocol).
The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.
Outcome measures
| Measure |
Somatropin
n=346 Participants
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 Participants
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures
|
0.5 hospitalisations
Standard Deviation 0.9
|
0.5 hospitalisations
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: week 0, trial terminationPopulation: No analysis was done since the trial was prematurely terminated before week 104 of the trial. Trial was terminated January 16th, 2009.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, trial terminationPopulation: FAS (full analysis set) is all subjects exposed to at least one dose of trial drug. Observations from end of trial visit is substitute for week 104. Not all subjects provided 'quality of life' data.
Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Somatropin
n=346 Participants
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 Participants
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Health Related Quality of Life Assessments
RSCL (overall mean), N= 316, 312
|
2.9 scores on a scale
Standard Deviation 0.9
|
3.0 scores on a scale
Standard Deviation 0.9
|
|
Health Related Quality of Life Assessments
ESAS (overall mean), N= 309, 313
|
3.0 scores on a scale
Standard Deviation 1.9
|
3.0 scores on a scale
Standard Deviation 2.0
|
|
Health Related Quality of Life Assessments
EQ-5D (UK overall score), N= 305, 299
|
0.596 scores on a scale
Standard Deviation 0.310
|
0.597 scores on a scale
Standard Deviation 0.321
|
|
Health Related Quality of Life Assessments
SF-36 (overall physical health), N= 318, 315
|
48 scores on a scale
Standard Deviation 22
|
49 scores on a scale
Standard Deviation 22
|
|
Health Related Quality of Life Assessments
SF-36 (overall mental health), N= 318, 315
|
61 scores on a scale
Standard Deviation 21
|
62 scores on a scale
Standard Deviation 21
|
Adverse Events
Somatropin
Serious events: 122 serious events
Other events: 225 other events
Deaths: 0 deaths
Placebo
Serious events: 136 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Somatropin
n=346 participants at risk
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 participants at risk
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
4/346 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.29%
1/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
7/346 • Number of events 9 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
3.4%
12/349 • Number of events 15 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
4/346 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.6%
9/349 • Number of events 10 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
7/346 • Number of events 7 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.4%
5/349 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.3%
8/349 • Number of events 9 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
5/346 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.4%
5/346 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Angina pectoris
|
0.87%
3/346 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.1%
4/349 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.7%
6/349 • Number of events 6 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac failure
|
0.87%
3/346 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Arrhythmia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.29%
1/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Angina unstable
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Atrial thrombosis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Nodal rhythm
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Endocrine disorders
Cushing's syndrome
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Endocrine disorders
Goitre
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Endocrine disorders
Thyroid mass
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
5/346 • Number of events 6 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.6%
9/349 • Number of events 9 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Colitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Faecaloma
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastroduodenitis haemorrhagic
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Peritonitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Death
|
1.2%
4/346 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Non-cardiac chest pain
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Multi-organ failure
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Pyrexia
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Sudden death
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Asthenia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Chest discomfort
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Chest pain
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Fatigue
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Impaired healing
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Oedema
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Immune system disorders
Kidney transplant rejection
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Pneumonia
|
2.9%
10/346 • Number of events 11 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.3%
8/349 • Number of events 9 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Sepsis
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.0%
7/349 • Number of events 8 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Cellulitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.4%
5/349 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Gangrene
|
0.87%
3/346 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.1%
4/349 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
4/346 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Bacteraemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Osteomyelitis
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Septic shock
|
0.87%
3/346 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Urosepsis
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Catheter sepsis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Localised infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Urinary tract infection
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Abscess limb
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Arteriovenous graft site abscess
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Catheter bacteraemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Catheter related infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Central line infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Endocarditis bacterial
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Graft infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Herpes zoster
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Herpes zoster oticus
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Infection
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Influenza
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Necrotising fasciitis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Orchitis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Pathogen resistance
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Wound infection
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Underdose
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Wound decomposition
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Investigations
Cardiac murmur
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Investigations
Hepatic enzyme increased
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.7%
6/346 • Number of events 7 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.4%
5/349 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.0%
7/349 • Number of events 7 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.87%
3/346 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.58%
2/346 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.29%
1/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the duodenum
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Convulsion
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Chorea
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Embolic stroke
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Paraesthesia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Parkinson's disease
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Presyncope
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Psychiatric disorders
Mental status changes
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Psychiatric disorders
Alcohol abuse
|
0.29%
1/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Psychiatric disorders
Confusional state
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Renal and urinary disorders
Azotaemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Renal and urinary disorders
Haematuria
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
5/346 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.0%
7/349 • Number of events 9 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
2.0%
7/349 • Number of events 7 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.4%
5/349 • Number of events 5 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
1.1%
4/349 • Number of events 4 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.86%
3/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Hypotension
|
0.58%
2/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 3 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/346 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Haematoma
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.57%
2/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 2 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Arterial occlusive disease
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Exsanguination
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Hypovolaemic shock
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Lymphocele
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Shock
|
0.00%
0/346 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.29%
1/349 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Thrombosis
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Vascular rupture
|
0.29%
1/346 • Number of events 1 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
0.00%
0/349 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
Other adverse events
| Measure |
Somatropin
n=346 participants at risk
Somatropin 20 mcg/kg once daily, week 0 to end of trial
|
Placebo
n=349 participants at risk
Placebo once daily, week 0 to end of trial
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.4%
29/346 • Number of events 41 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
10.3%
36/349 • Number of events 39 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
23/346 • Number of events 28 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
10.3%
36/349 • Number of events 38 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
17/346 • Number of events 23 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
8.3%
29/349 • Number of events 31 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
General disorders
Asthenia
|
2.6%
9/346 • Number of events 11 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
5.4%
19/349 • Number of events 19 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
18/346 • Number of events 18 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
3.2%
11/349 • Number of events 11 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
25/346 • Number of events 30 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
5.4%
19/349 • Number of events 22 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
21/346 • Number of events 23 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
6.3%
22/349 • Number of events 25 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Nervous system disorders
Headache
|
6.6%
23/346 • Number of events 36 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
6.3%
22/349 • Number of events 25 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.4%
22/346 • Number of events 24 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
6.3%
22/349 • Number of events 28 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
14/346 • Number of events 14 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
7.2%
25/349 • Number of events 28 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
|
Vascular disorders
Hypotension
|
6.9%
24/346 • Number of events 33 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
6.6%
23/349 • Number of events 26 • The adverse events were collected from July 2007 to January 2009.
The safety analysis set contains all randomised subjects exposed to at least one dose of trial medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER