Trial Outcomes & Findings for Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (NCT NCT00486434)
NCT ID: NCT00486434
Last Updated: 2019-04-26
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
COMPLETED
Study phase
PHASE3
Target enrollment
1176 participants
Primary outcome timeframe
Change from baseline to 24 months
Results posted on
2019-04-26
Participant Flow
Participant milestones
| Measure |
Active Arm
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
588
|
588
|
|
Overall Study
COMPLETED
|
394
|
454
|
|
Overall Study
NOT COMPLETED
|
194
|
134
|
Reasons for withdrawal
| Measure |
Active Arm
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
34
|
39
|
|
Overall Study
Adverse Event
|
118
|
44
|
|
Overall Study
Protocol Violation
|
22
|
21
|
|
Overall Study
Lack of Efficacy
|
12
|
19
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Personal reasons
|
5
|
6
|
Baseline Characteristics
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Active Arm
n=588 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=588 Participants
1 SMC021 Placebo tablet twice daily
|
Total
n=1176 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
|
293 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
614 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
295 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
562 Participants
n=5 Participants
|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 6.84 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 6.41 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
418 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
804 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
370 participants
n=5 Participants
|
369 participants
n=7 Participants
|
739 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 7 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 |
Active Arm
n=585 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 Participants
1 SMC021 Placebo tablet twice daily
|
Total
Total number of subjects between the two groups
|
|---|---|---|---|
|
Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
|
-0.188 mm
Standard Deviation 0.5626
|
-0.198 mm
Standard Deviation 0.5069
|
—
|
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 7 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 function 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 |
Active Arm
n=585 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 Participants
1 SMC021 Placebo tablet twice daily
|
Total
Total number of subjects between the two groups
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
|
-124.0 Units on a scale
Interval -391.0 to 218.0
|
-109.0 Units on a scale
Interval -410.0 to 349.0
|
—
|
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 7 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 degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).
Outcome measures
| Measure |
Active Arm
n=585 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 Participants
1 SMC021 Placebo tablet twice daily
|
Total
Total number of subjects between the two groups
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
|
-390.0 Units on a scale
Interval -1307.0 to 783.0
|
-299.5 Units on a scale
Interval -1342.0 to 915.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Month 24Population: ITT Population. The number analyzed in some rows differs from the overall number analyzed due to missing values from patients who prematurely discontinued.
The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.
Outcome measures
| Measure |
Active Arm
n=585 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 Participants
1 SMC021 Placebo tablet twice daily
|
Total
Total number of subjects between the two groups
|
|---|---|---|---|
|
Changes in Biochemical Markers of Bone & Cartilage Metabolism.
Serum CTX-I (ng/mL)
|
41.358 percentage of change
Standard Deviation 68.1153
|
62.883 percentage of change
Standard Deviation 65.7225
|
—
|
|
Changes in Biochemical Markers of Bone & Cartilage Metabolism.
Serum Osteocalcin (ng/mL)
|
-9.134 percentage of change
Standard Deviation 22.1368
|
1.785 percentage of change
Standard Deviation 22.8324
|
—
|
|
Changes in Biochemical Markers of Bone & Cartilage Metabolism.
24-h urine CTX-I/creatinine (µg/mmol)
|
-8.959 percentage of change
Standard Deviation 50.0723
|
8.311 percentage of change
Standard Deviation 55.4934
|
—
|
|
Changes in Biochemical Markers of Bone & Cartilage Metabolism.
24-h urine CTX-II/creatinine (ng/mmol)
|
0.484 percentage of change
Standard Deviation 56.4879
|
11.266 percentage of change
Standard Deviation 49.6250
|
—
|
SECONDARY outcome
Timeframe: Baseline and Month 24Population: About 15% of the ITT population had hand OA at baseline and only these subjects were included in the X-ray assessments.The AUSCAN questionnaire was administered to all the patients at sites in Denmark, the Czech Republic, and Romania.
To assess disease progression of OA affected joints, X-rays of both hands were performed \& assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, \& joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses. The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.
Outcome measures
| Measure |
Active Arm
n=585 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 Participants
1 SMC021 Placebo tablet twice daily
|
Total
Total number of subjects between the two groups
|
|---|---|---|---|
|
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Total osteophytes
|
0.40 Scores on a scale
Standard Deviation 0.784
|
0.40 Scores on a scale
Standard Deviation 0.754
|
—
|
|
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Total JSN
|
0.45 Scores on a scale
Standard Deviation 1.063
|
0.62 Scores on a scale
Standard Deviation 0.990
|
—
|
|
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Total cyst/erosions
|
0.83 Scores on a scale
Standard Deviation 1.204
|
0.82 Scores on a scale
Standard Deviation 1.327
|
—
|
|
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Total osteophytes, JSN and cyst/erosions
|
1.68 Scores on a scale
Standard Deviation 2.682
|
1.84 Scores on a scale
Standard Deviation 2.714
|
—
|
|
Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
AUSCAN total score
|
-51.5 Scores on a scale
Standard Deviation 265.13
|
-38.1 Scores on a scale
Standard Deviation 272.07
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Month 24Population: ITT population. A patient with multiple occurrences of a TEAE under one treatment is counted only once in the AE category for that treatment.
Adverse events were by system organ class of all patients.
Outcome measures
| Measure |
Active Arm
n=585 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 Participants
1 SMC021 Placebo tablet twice daily
|
Total
n=1169 Participants
Total number of subjects between the two groups
|
|---|---|---|---|
|
Nature and # of AEs Monitored Continuously During Study
Vascular disorders
|
160 Number of AEs by system organ class
|
92 Number of AEs by system organ class
|
252 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Any primary system organ class
|
548 Number of AEs by system organ class
|
520 Number of AEs by system organ class
|
1068 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Blood and lymphatic system disorders
|
18 Number of AEs by system organ class
|
16 Number of AEs by system organ class
|
34 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Cardiac disorders
|
38 Number of AEs by system organ class
|
30 Number of AEs by system organ class
|
68 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Congenital, familial and genetic disorders
|
1 Number of AEs by system organ class
|
0 Number of AEs by system organ class
|
1 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Ear and labyrinth disorders
|
14 Number of AEs by system organ class
|
12 Number of AEs by system organ class
|
26 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Endocrine disorders
|
9 Number of AEs by system organ class
|
9 Number of AEs by system organ class
|
18 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Eye disorders
|
17 Number of AEs by system organ class
|
22 Number of AEs by system organ class
|
39 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Gastrointestinal disorders
|
268 Number of AEs by system organ class
|
150 Number of AEs by system organ class
|
418 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
General disorders and administration site condit.
|
60 Number of AEs by system organ class
|
53 Number of AEs by system organ class
|
113 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Hepatobiliary disorders
|
11 Number of AEs by system organ class
|
10 Number of AEs by system organ class
|
21 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Immune system disorders
|
8 Number of AEs by system organ class
|
4 Number of AEs by system organ class
|
12 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Infections and infestations
|
231 Number of AEs by system organ class
|
249 Number of AEs by system organ class
|
480 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Injury, poisoning and procedural complications
|
87 Number of AEs by system organ class
|
95 Number of AEs by system organ class
|
182 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Investigations
|
53 Number of AEs by system organ class
|
53 Number of AEs by system organ class
|
106 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Metabolism and nutrition disorders
|
76 Number of AEs by system organ class
|
64 Number of AEs by system organ class
|
140 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Musculoskeletal and connective tissue disorders
|
231 Number of AEs by system organ class
|
267 Number of AEs by system organ class
|
498 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Neoplasms benign, malignant and unspecified
|
27 Number of AEs by system organ class
|
16 Number of AEs by system organ class
|
43 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Nervous system disorders
|
96 Number of AEs by system organ class
|
87 Number of AEs by system organ class
|
183 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Psychiatric disorders
|
28 Number of AEs by system organ class
|
27 Number of AEs by system organ class
|
55 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Renal and urinary disorders
|
19 Number of AEs by system organ class
|
14 Number of AEs by system organ class
|
33 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Reproductive system and breast disorders
|
18 Number of AEs by system organ class
|
20 Number of AEs by system organ class
|
38 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Respiratory, thoracic and mediastinal disorders
|
48 Number of AEs by system organ class
|
49 Number of AEs by system organ class
|
97 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Skin and subcutaneous tissue disorders
|
69 Number of AEs by system organ class
|
36 Number of AEs by system organ class
|
105 Number of AEs by system organ class
|
|
Nature and # of AEs Monitored Continuously During Study
Surgical and medical procedures
|
27 Number of AEs by system organ class
|
30 Number of AEs by system organ class
|
57 Number of AEs by system organ class
|
SECONDARY outcome
Timeframe: From Baseline to Month 24Population: MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania.
Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for 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 |
Active Arm
n=268 Participants
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=261 Participants
1 SMC021 Placebo tablet twice daily
|
Total
Total number of subjects between the two groups
|
|---|---|---|---|
|
Disease Progression in the Knee Evaluated by MRI.
Total cartilage thickness m24
|
3.1777 percentage of change
Standard Deviation 6.22356
|
2.2467 percentage of change
Standard Deviation 7.09590
|
—
|
|
Disease Progression in the Knee Evaluated by MRI.
Total cartilage volume m12
|
2.90 percentage of change
Standard Deviation 10.104
|
0.26 percentage of change
Standard Deviation 9.283
|
—
|
|
Disease Progression in the Knee Evaluated by MRI.
Total cartilage volume m24
|
4.79 percentage of change
Standard Deviation 10.352
|
1.94 percentage of change
Standard Deviation 9.257
|
—
|
|
Disease Progression in the Knee Evaluated by MRI.
Total cartilage thickness m12
|
1.9921 percentage of change
Standard Deviation 7.05068
|
0.4343 percentage of change
Standard Deviation 6.90177
|
—
|
Adverse Events
Active Arm
Serious events: 100 serious events
Other events: 548 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 88 serious events
Other events: 520 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Arm
n=585 participants at risk
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 participants at risk
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
11/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.1%
12/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Bone graft
|
0.68%
4/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.2%
7/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.85%
5/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.51%
3/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.51%
3/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.51%
3/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Chest pain
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.51%
3/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Metabolism and nutrition disorders
Obesity
|
0.51%
3/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.51%
3/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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)
Benign breast neoplasm
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Chronic obstructive pulmonary disease
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Diverticulitis
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.34%
2/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Tachycardia
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.34%
2/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Anaemia
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Iron deficiency anaemia
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Coronary artery dilatation
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Endocrine disorders
Goitre
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Ascites
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Diverticulum
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Volvulus
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Accidental death
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Device malfunction
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Malaise
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Appendicitis
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Cystitis
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Erysipelas
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Lyme disease
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Mastoiditis
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Pyelonephritis acute
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Sinusitis
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Concussion
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Fall
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Foot fracture
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Foreign body
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Hand fracture
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Humerus fracture
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Jaw fracture
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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 injury
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Lower limb fracture
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Meniscus lesion
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Nerve injury
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Post lumbar puncture syndrome
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Spinal compression fracture
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Tendon rupture
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Bursitis
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Chondropathy
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Spondylolisthesis
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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)
Bile duct cancer
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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)
Cervix carcinoma
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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)
Ovarian cancer
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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)
Rectal cancer
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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)
Squamous cell carcinoma
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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 leimyoma
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Headache
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Migraine
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Sciatica
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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 incontinence
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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 prolapse
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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 retension
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Prostatomegaly
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Uterine haemorrhage
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Vaginal prolapse
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Interstitial lung disease
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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 oedema
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Respiratory failure
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Peau d´orange
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Rash
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Abscess drainage
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Cardial pacemaker insertion
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Gastric bypass
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Radical hysterectomy
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.17%
1/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Hypertension
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Intermittent claudication
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Circulatory collapse
|
0.17%
1/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.00%
0/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
Other adverse events
| Measure |
Active Arm
n=585 participants at risk
0.8mg SMC021 Oral Calcitonin tablet twice daily
|
Placebo Arm
n=584 participants at risk
1 SMC021 Placebo tablet twice daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
89/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
15.9%
93/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Hot flush
|
17.8%
104/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.1%
24/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
10.6%
62/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
10.1%
59/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
14.0%
82/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.1%
18/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Vascular disorders
Hypertension
|
7.9%
46/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
8.9%
52/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
43/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
9.4%
55/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Influenza
|
6.2%
36/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
8.9%
52/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
6.2%
36/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
8.9%
52/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.1%
59/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.5%
26/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
56/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.3%
25/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
6.5%
38/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
5.1%
30/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
5.1%
30/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
6.2%
36/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Headache
|
6.0%
35/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.8%
28/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Cystitis
|
6.0%
35/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.9%
17/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Pneumonia
|
4.8%
28/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.1%
24/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
3.6%
21/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
5.1%
30/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
5.0%
29/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.4%
20/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
4.4%
26/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.4%
20/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Nervous system disorders
Dizziness
|
3.1%
18/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
4.3%
25/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
3.1%
18/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.3%
19/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Bronchitis
|
2.6%
15/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.3%
19/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Sinusitis
|
2.9%
17/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.6%
15/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Viral infections
|
1.7%
10/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
3.6%
21/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
2.7%
16/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.4%
14/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
3.2%
19/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.7%
10/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
4.3%
25/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.51%
3/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
2.7%
16/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.1%
12/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
2.2%
13/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.9%
11/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Fatigue
|
1.7%
10/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.4%
14/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
10/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.4%
14/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
General disorders
Oedema peripheral
|
1.7%
10/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.4%
14/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
12/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.9%
11/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Muscle spasms
|
1.0%
6/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.7%
16/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
2.2%
13/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.5%
9/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Psychiatric disorders
Depression
|
2.4%
14/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.2%
7/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
13/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.2%
7/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
|
1.4%
8/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
2.1%
12/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 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
Rash
|
2.1%
12/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
1.0%
6/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
13/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.86%
5/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
13/585 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
0.68%
4/584 • From baseline until 30 days following the end of study.
The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60