Trial Outcomes & Findings for Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study) (NCT NCT00704847)
NCT ID: NCT00704847
Last Updated: 2019-04-24
Results Overview
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1030 participants
Primary outcome timeframe
Change from baseline to 24 months
Results posted on
2019-04-24
Participant Flow
Patients were enrolled at 18 centers in 10 countries: 6 centers in the US, 1 center in the UK, 1 center in Spain,1 center in the Czech Republic, 3 centers in Denmark, 1 center in Hong Kong, 2 centers in Poland, 1 center in Romania, 1 center in Belgium and 1 center in Canada. First patient randomized: 1 Aug 08 Last patient visit: 10 May 2011
Participant milestones
| Measure |
SMC021 Oral Calcitonin
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
521
|
509
|
|
Overall Study
COMPLETED
|
300
|
339
|
|
Overall Study
NOT COMPLETED
|
221
|
170
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)
Baseline characteristics by cohort
| Measure |
SMC021 Oral Calcitonin
n=521 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=509 Participants
1 SMC021 Placebo tablet twice daily
|
Total
n=1030 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
292 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
580 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
229 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
321 Participants
n=5 Participants
|
305 Participants
n=7 Participants
|
626 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
72 participants
n=5 Participants
|
72 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
67 participants
n=5 Participants
|
66 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
263 participants
n=5 Participants
|
264 participants
n=7 Participants
|
527 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 24 monthsPopulation: The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=520 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months
|
-0.32 mm
Standard Deviation 0.693
|
-0.40 mm
Standard Deviation 0.768
|
PRIMARY outcome
Timeframe: Change from baseline to 24 monthsPopulation: The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=520 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index
|
-80.6 Units on a scale
Standard Deviation 112.22
|
-87.9 Units on a scale
Standard Deviation 116.25
|
SECONDARY outcome
Timeframe: From baseline to 24 monthsPopulation: The number of participants analysed for these outcomes were a total of 150 subjects from the intent-to-treat (ITT) population evenly distributed across sites, all with completed baseline as well as all follow-up visits.
The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=69 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=81 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
Serum CTX-I (ng/mL)
|
50.6 percentage of change
Standard Deviation 83.74
|
40.6 percentage of change
Standard Deviation 45.52
|
|
Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
Serum Osteocalcin (ng/mL)
|
3.6 percentage of change
Standard Deviation 37.42
|
3.9 percentage of change
Standard Deviation 26.32
|
|
Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
24-h urine CTX-I/creatinine (µg/mmol)
|
9.8 percentage of change
Standard Deviation 85.95
|
7.2 percentage of change
Standard Deviation 44.36
|
|
Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
24-h urine CTX-II/creatinine (ng/mmol)
|
2.6 percentage of change
Standard Deviation 63.13
|
2.3 percentage of change
Standard Deviation 51.07
|
SECONDARY outcome
Timeframe: From baseline to month 12 and month 24Population: Subset of patients from the sites in Ballerup (Denmark), Czech Republic and Romania
Knee cartilage volume and thickness was assessed by MRI in patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=152 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=149 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Knee Disease Progression Assessed by MRI
Cartilage Volume Month 24
|
2.6 percentage of change
Standard Deviation 10.18
|
3.5 percentage of change
Standard Deviation 12.73
|
|
Knee Disease Progression Assessed by MRI
Cartilage Thickness Month 12
|
4.7 percentage of change
Standard Deviation 10.64
|
4.7 percentage of change
Standard Deviation 8.24
|
|
Knee Disease Progression Assessed by MRI
Cartilage Thickness Month 24
|
4.5 percentage of change
Standard Deviation 10.78
|
4.1 percentage of change
Standard Deviation 8.67
|
|
Knee Disease Progression Assessed by MRI
Cartilage Volume Month 12
|
3.4 percentage of change
Standard Deviation 9.11
|
3.0 percentage of change
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: From baseline to months 1, 6, 12 and 24Population: The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 1992): I. Completely able to perform usual activities of daily living (self-care, vocational and avocational) II. Able to perform usual self-care and vocational activities, but limited in avocational activities. III. Able to perform usual self-care activities, but limited in vocational and avocational activities. IV. Limited ability to perform usual self-care activities, vocational and avocational activities. Self-care activities included dressing, feeding, bathing, grooming, and toileting. Avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities were patient-desired and age- and sex-specific.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=520 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Questionnaire to Assess Function and Physical Activity
Month 12
|
-28.0 percentage of change
Standard Deviation 53.97
|
-28.4 percentage of change
Standard Deviation 59.79
|
|
Questionnaire to Assess Function and Physical Activity
Month 24
|
-30.3 percentage of change
Standard Deviation 77.51
|
-25.1 percentage of change
Standard Deviation 143.05
|
|
Questionnaire to Assess Function and Physical Activity
Month 1
|
-4.8 percentage of change
Standard Deviation 44.89
|
-1.9 percentage of change
Standard Deviation 131.20
|
|
Questionnaire to Assess Function and Physical Activity
Month 6
|
-22.6 percentage of change
Standard Deviation 49.03
|
-17.9 percentage of change
Standard Deviation 64.15
|
SECONDARY outcome
Timeframe: Baseline to month 24Population: The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
WOMAC's stiffness subscore was used to assess the stiffness in the signal knee. WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of joint stiffness for when performing each daily function listed in the questionnaire. 0 is no stiffness (best), 100 is extreme stiffness (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 200. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less stiffness). Patients were instructed not to take analgesics for 3 days prior to the WOMAC test.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=520 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Questionnaire to Assess Stiffness in the Signal Knee.
|
-26.1 percentage of change
Standard Deviation 90.88
|
-20.3 percentage of change
Standard Deviation 179.22
|
SECONDARY outcome
Timeframe: From baseline to month 24Population: The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Health-related quality of life was assessed by the EQ-5D questionnaire, which is a patient questionnaire for measure of health, developed by the EuroQol Group.The EQ-5D questionnaire was administered to patients in order to measure change in health-related quality of life (HRQoL) over 2 years. The subjects marks on a VAS scale from 0 to 100 the number that best describes their health today (0 is worst imaginable health state and 100 is best imaginable health state). The change from baseline in the EQ-5D VAS was calculated.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=515 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=504 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Questionnaire to Assess Health-related Quality of Life
|
13.70 percentage of change
Standard Deviation 38.763
|
11.82 percentage of change
Standard Deviation 40.645
|
SECONDARY outcome
Timeframe: Baseline, month 1, month 6, month 12, month 24Population: The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled "No Pain" and 100 equaled "Worst Pain Imaginable". Patients were instructed not to take analgesics for 3 days prior to the VAS.
Outcome measures
| Measure |
SMC021 Oral Calcitonin
n=520 Participants
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 Participants
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Questionnaire to Assess Pain
Month 1
|
-6.7 percentage of change
Standard Deviation 49.50
|
-9.1 percentage of change
Standard Deviation 45.26
|
|
Questionnaire to Assess Pain
Month 6
|
-26.9 percentage of change
Standard Deviation 51.73
|
-26.9 percentage of change
Standard Deviation 50.43
|
|
Questionnaire to Assess Pain
Month 12
|
-31.0 percentage of change
Standard Deviation 68.05
|
-34.6 percentage of change
Standard Deviation 61.30
|
|
Questionnaire to Assess Pain
Month 24
|
-35.1 percentage of change
Standard Deviation 91.63
|
-37.1 percentage of change
Standard Deviation 77.55
|
Adverse Events
SMC021 Oral Calcitonin
Serious events: 77 serious events
Other events: 474 other events
Deaths: 0 deaths
SMC021 Placebo
Serious events: 80 serious events
Other events: 459 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SMC021 Oral Calcitonin
n=520 participants at risk
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 participants at risk
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.59%
3/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.58%
3/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Cardiac arrest
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Endocrine disorders
Goitre
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Endocrine disorders
Hyperparathyrodism
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Crohn´s disease
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Chest pain
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Foreign body reaction
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Hepatobiliary disorders
Jaundice
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Diverticulitis
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Infection
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Orchitis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Pancreatic abscess
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Investigations
Prostatic specific antigen increased
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.59%
3/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
6/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.2%
6/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.77%
4/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.6%
8/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.58%
3/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.96%
5/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.98%
5/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.58%
3/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Morton´s neuroma
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.38%
2/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Amytrophic lateral sclerosis
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Sciatica
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Psychiatric disorders
Depression
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.39%
2/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic hernia
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Social circumstances
Joint prosthesis user
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Aortic surgery
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Cataract operation
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Joint stabilisation
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Circulatory collapse
|
0.19%
1/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
Other adverse events
| Measure |
SMC021 Oral Calcitonin
n=520 participants at risk
0.8 mg SMC021 Oral Calcitonin twice daily
|
SMC021 Placebo
n=508 participants at risk
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
86/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
21.9%
111/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Hot flush
|
16.9%
88/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.3%
22/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
52/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
10.6%
54/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
77/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.0%
15/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Influenza
|
8.8%
46/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
7.9%
40/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
34/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
7.7%
39/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
45/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
5.3%
27/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Hypertension
|
6.0%
31/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
7.7%
39/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.2%
48/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.1%
21/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Headache
|
5.0%
26/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
5.3%
27/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
27/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.5%
23/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Dizziness
|
6.2%
32/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.3%
17/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.6%
24/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.7%
24/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
26/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.9%
20/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
20/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.5%
23/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.7%
14/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.9%
25/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Pneumonia
|
3.8%
20/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.0%
15/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
19/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.0%
15/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Cystitis
|
2.5%
13/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.1%
21/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Viral infection
|
3.1%
16/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.5%
18/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
16/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.0%
15/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Oedema peripheral
|
3.3%
17/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.8%
14/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Bronchitis
|
3.7%
19/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.2%
11/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.9%
10/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.9%
20/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Influenza like illness
|
2.9%
15/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.8%
14/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Tooth infection
|
1.9%
10/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.1%
16/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
11/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.8%
14/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
14/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.0%
10/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
13/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.8%
9/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Sinusitis
|
1.3%
7/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.8%
14/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
12/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.6%
8/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
14/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.79%
4/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.3%
7/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.2%
11/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Sciatica
|
2.1%
11/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.4%
7/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Fatigue
|
2.3%
12/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.98%
5/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
15/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.20%
1/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.96%
5/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.0%
10/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.96%
5/520 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.0%
10/508 • From baseline to 30 days following the end of participation
The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
Additional Information
Bente Juel Riis, Medical Director
Nordic Bioscience A/S
Phone: +45 22901317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60