Trial Outcomes & Findings for A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D (NCT NCT00525798)
NCT ID: NCT00525798
Last Updated: 2012-10-29
Results Overview
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4665 participants
Primary outcome timeframe
From baseline to month 36
Results posted on
2012-10-29
Participant Flow
Patients were enrolled at 16 centers in 12 countries: 3 centers in the US and 3 centers in Denmark. 1 center in Brazil, Estonia, Czech Republic, Poland, Lithuania, Romania, Italy, France, Hong Kong, and China. First patient randomized: 26 Feb 2007 Last patient visit: 30 Jul 2011
Participant milestones
| Measure |
SMC021
1 tablet of 0,80 mg SMC021 daily
|
Placebo
1 tablet of placebo daily
|
|---|---|---|
|
Overall Study
STARTED
|
2334
|
2331
|
|
Overall Study
COMPLETED
|
1578
|
1732
|
|
Overall Study
NOT COMPLETED
|
756
|
599
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Baseline characteristics by cohort
| Measure |
SMC021
n=2334 Participants
1 tablet of 0,80 mg SMC021 daily
|
Placebo
n=2331 Participants
1 tablet of placebo daily
|
Total
n=4665 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
|
912 Participants
n=5 Participants
|
860 Participants
n=7 Participants
|
1772 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1422 Participants
n=5 Participants
|
1471 Participants
n=7 Participants
|
2893 Participants
n=5 Participants
|
|
Age Continuous
|
66.5 years
STANDARD_DEVIATION 6.12 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 6.16 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 6.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2334 Participants
n=5 Participants
|
2331 Participants
n=7 Participants
|
4665 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
74 participants
n=5 Participants
|
73 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
230 participants
n=5 Participants
|
232 participants
n=7 Participants
|
462 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
167 participants
n=5 Participants
|
166 participants
n=7 Participants
|
333 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
492 participants
n=5 Participants
|
492 participants
n=7 Participants
|
984 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
176 participants
n=5 Participants
|
176 participants
n=7 Participants
|
352 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
149 participants
n=5 Participants
|
150 participants
n=7 Participants
|
299 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
172 participants
n=5 Participants
|
171 participants
n=7 Participants
|
343 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
599 participants
n=5 Participants
|
598 participants
n=7 Participants
|
1197 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
China
|
224 participants
n=5 Participants
|
224 participants
n=7 Participants
|
448 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to month 36Population: all patients randomized who received at least one dose of study drug, with the addition of evaluable baseline spine X-ray and at least one follow-up for calculation of vertebral fractures.
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
Outcome measures
| Measure |
SMC021
n=2064 Participants
1 tablet of 0,80 mg SMC021 daily
|
Placebo
n=2125 Participants
1 tablet of placebo daily
|
|---|---|---|
|
Number of Patients With New Vertebral Fractures
|
94 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: From baseline to month 36Population: all randomized patients
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures. Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
Outcome measures
| Measure |
SMC021
n=2334 Participants
1 tablet of 0,80 mg SMC021 daily
|
Placebo
n=2331 Participants
1 tablet of placebo daily
|
|---|---|---|
|
Number of Patients With Non-vertebral Fractures
|
75 Participants
|
82 Participants
|
Adverse Events
SMC021
Serious events: 340 serious events
Other events: 2152 other events
Deaths: 0 deaths
Placebo
Serious events: 378 serious events
Other events: 2141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SMC021
n=2334 participants at risk
1 tablet of 0,80 mg SMC021 daily
|
Placebo
n=2331 participants at risk
1 tablet of placebo daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
10/2334 • From baseline to 36 month
|
0.34%
8/2331 • From baseline to 36 month
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
6/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
5/2334 • From baseline to 36 month
|
0.21%
5/2331 • From baseline to 36 month
|
|
Cardiac disorders
Angina pectoris
|
0.21%
5/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Cardiac disorders
Myocardial ischaemia
|
0.17%
4/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Cardiac disorders
Angina unstable
|
0.13%
3/2334 • From baseline to 36 month
|
0.26%
6/2331 • From baseline to 36 month
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
3/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Cardiac disorders
Arrhytmia
|
0.13%
3/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Cardiac failure
|
0.13%
3/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Cardiac failure congestive
|
0.13%
3/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Atrial flutter
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Aortic valve stenosis
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Sick sinus syndrome
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Bradycardia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Pericarditis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Tachycardia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Coronary artery dilatation
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Cardiac disorders
Ventricular failure
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Congenital, familial and genetic disorders
Hereditary haemorrhagic telangiectasia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Congenital, familial and genetic disorders
Abdominal wall anomaly
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Vertigo
|
0.04%
1/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Deafness
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Meniere´s disease
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Endocrine disorders
Goitre
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Endocrine disorders
Hypothyroidism
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Endocrine disorders
Thyroid disorder
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Endocrine disorders
Hypothyroidic goitre
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Eye disorders
Cataract
|
0.26%
6/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Eye disorders
Glaucoma
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Eye disorders
Retinal detachment
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Eye disorders
Macular degeneration
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Eye disorders
Maculopathy
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Eye disorders
Scleritis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Eye disorders
Eye disorder
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Eye disorders
Optic atrophy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
3/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.13%
3/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Dyspepsia
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Ileus
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Colonic polyp
|
0.04%
1/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.04%
1/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Colitis
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Diarrhoea
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Femoral hernia
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Coeliac disease
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Enterocele
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Food poisoning
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Melaena
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
General disorders
Chest pain
|
0.13%
3/2334 • From baseline to 36 month
|
0.34%
8/2331 • From baseline to 36 month
|
|
General disorders
Death
|
0.13%
3/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
General disorders
Pyrexia
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
General disorders
Adverse drug reaction
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
General disorders
Device occlusion
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
General disorders
Oedema peripheral
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
General disorders
Thrombosis in device
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
General disorders
Chest discomfort
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
General disorders
Accidental death
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
General disorders
Sudden cardiac death
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
General disorders
Ulcer
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.81%
19/2334 • From baseline to 36 month
|
0.39%
9/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Pneumonia
|
0.51%
12/2334 • From baseline to 36 month
|
0.47%
11/2331 • From baseline to 36 month
|
|
Infections and infestations
Diverticulitis
|
0.13%
3/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Infections and infestations
Appendicitis
|
0.13%
3/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Urinary tract infection
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Infections and infestations
Bronchitis
|
0.04%
1/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Infections and infestations
Gastroenteritis
|
0.04%
1/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Infections and infestations
Pyelonephritis
|
0.04%
1/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Infections and infestations
Septic shock
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Urosepsis
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Bacterial infection
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Cystitis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Encephalitis viral
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Gallbladder empyema
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Gangrene
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Hepatitis C
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Perineal infection
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Pyelonephritis acute
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Tuberculosis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Infections and infestations
Erysipelas
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Infection
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Neurological infection
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Paronychia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Pyometra
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Sepsis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.34%
8/2334 • From baseline to 36 month
|
0.34%
8/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
5/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Humurus fracture
|
0.17%
4/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
3/2334 • From baseline to 36 month
|
0.39%
9/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
3/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
2/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Burns secound degree
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Face injury
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Perineal laceration
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Investigations
Electrocardiogram QT prolonged
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Investigations
International normalised ratio increased
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Investigations
Arteriogram coronary
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Investigations
Arthroscopy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
1/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Metabolism and nutrition disorders
Dehydration
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.81%
19/2334 • From baseline to 36 month
|
0.73%
17/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
3/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.13%
3/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.09%
2/2334 • From baseline to 36 month
|
0.21%
5/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
2/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.04%
1/2334 • From baseline to 36 month
|
0.26%
6/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.60%
14/2334 • From baseline to 36 month
|
0.51%
12/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.13%
3/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
2/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adult T-cell lymphoma/leukaemia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix neoplasm
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometríal cancer
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma of breast
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamos cell carcinoma of skin
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine carcinoma in situ
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage III
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal haemangioma
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
10/2334 • From baseline to 36 month
|
0.34%
8/2331 • From baseline to 36 month
|
|
Nervous system disorders
Ischaemic stroke
|
0.21%
5/2334 • From baseline to 36 month
|
0.21%
5/2331 • From baseline to 36 month
|
|
Nervous system disorders
Syncope
|
0.13%
3/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
2/2334 • From baseline to 36 month
|
0.39%
9/2331 • From baseline to 36 month
|
|
Nervous system disorders
Headache
|
0.04%
1/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Dizziness
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Loss of consciousness
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Brain stem infarction
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Brain stem thrombosis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Diabetic neuropathy
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Neuropathy peripheral
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Paraesthesia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Nervous system disorders
Amnesia
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Convulsion
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Paralysis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Psychiatric disorders
Depression
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Psychiatric disorders
Insomnia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Urinary incontinence
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Renal cyst
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Bladder prolapse
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Urethral polyp
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Cystocele
|
0.09%
2/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.09%
2/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Rectocele
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.04%
1/2334 • From baseline to 36 month
|
0.21%
5/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.04%
1/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Hydrometra
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Genital disorder female
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
4/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.04%
1/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal polyp
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Social circumstances
Breast prothesis user
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Social circumstances
Joint prothesis user
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.13%
3/2334 • From baseline to 36 month
|
0.13%
3/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.13%
3/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Varicose vein operation
|
0.13%
3/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Appendicectomy
|
0.09%
2/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Mastectomy
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Wrist surgery
|
0.04%
1/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Bone operation
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Oophorectomy bilateral
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Vaginaplasty
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Vascular graft
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/2334 • From baseline to 36 month
|
0.30%
7/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Aortic bypass
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Breast prothesis removal
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Fracture reduction
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Gallbladder operation
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Genitourinary operation
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Osteosynthesis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Radical hysterectomy
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Vascular disorders
Hypertension
|
0.21%
5/2334 • From baseline to 36 month
|
0.17%
4/2331 • From baseline to 36 month
|
|
Vascular disorders
Varicose vein
|
0.13%
3/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Vascular disorders
Arteriosclerosis
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
2/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Vascular disorders
Femoral arterial stenosis
|
0.09%
2/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Aneurysm
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Arterial occlusive disease
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Circulatory collapse
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Hypotension
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Peripheral ischaemia
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Temporal arteritis
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.04%
1/2334 • From baseline to 36 month
|
0.00%
0/2331 • From baseline to 36 month
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/2334 • From baseline to 36 month
|
0.09%
2/2331 • From baseline to 36 month
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Vascular disorders
Vasculitis
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/2334 • From baseline to 36 month
|
0.04%
1/2331 • From baseline to 36 month
|
Other adverse events
| Measure |
SMC021
n=2334 participants at risk
1 tablet of 0,80 mg SMC021 daily
|
Placebo
n=2331 participants at risk
1 tablet of placebo daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.3%
357/2334 • From baseline to 36 month
|
5.0%
117/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.3%
311/2334 • From baseline to 36 month
|
14.5%
339/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
284/2334 • From baseline to 36 month
|
13.7%
320/2331 • From baseline to 36 month
|
|
Vascular disorders
Hot flush
|
11.3%
263/2334 • From baseline to 36 month
|
1.8%
41/2331 • From baseline to 36 month
|
|
Infections and infestations
Nasopharyngitis
|
11.2%
262/2334 • From baseline to 36 month
|
11.5%
269/2331 • From baseline to 36 month
|
|
Vascular disorders
Hypertension
|
10.2%
238/2334 • From baseline to 36 month
|
11.5%
267/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
228/2334 • From baseline to 36 month
|
5.5%
129/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Constipation
|
7.1%
165/2334 • From baseline to 36 month
|
7.4%
172/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
157/2334 • From baseline to 36 month
|
5.1%
120/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
153/2334 • From baseline to 36 month
|
4.6%
107/2331 • From baseline to 36 month
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
5.9%
137/2334 • From baseline to 36 month
|
6.4%
149/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.8%
136/2334 • From baseline to 36 month
|
8.0%
186/2331 • From baseline to 36 month
|
|
Infections and infestations
Influenza
|
5.7%
133/2334 • From baseline to 36 month
|
6.9%
160/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.5%
129/2334 • From baseline to 36 month
|
6.1%
142/2331 • From baseline to 36 month
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
123/2334 • From baseline to 36 month
|
0.60%
14/2331 • From baseline to 36 month
|
|
Nervous system disorders
Dizziness
|
5.1%
120/2334 • From baseline to 36 month
|
4.5%
105/2331 • From baseline to 36 month
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.1%
118/2334 • From baseline to 36 month
|
5.1%
120/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.9%
114/2334 • From baseline to 36 month
|
2.4%
57/2331 • From baseline to 36 month
|
|
Infections and infestations
Bronchitis
|
4.5%
104/2334 • From baseline to 36 month
|
5.4%
127/2331 • From baseline to 36 month
|
|
Infections and infestations
Pneumonia
|
4.4%
102/2334 • From baseline to 36 month
|
4.6%
108/2331 • From baseline to 36 month
|
|
Infections and infestations
Cystitis
|
4.3%
100/2334 • From baseline to 36 month
|
4.1%
96/2331 • From baseline to 36 month
|
|
Infections and infestations
Urinary tract infection
|
3.8%
88/2334 • From baseline to 36 month
|
4.1%
95/2331 • From baseline to 36 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
79/2334 • From baseline to 36 month
|
3.8%
88/2331 • From baseline to 36 month
|
|
Nervous system disorders
Headache
|
3.1%
72/2334 • From baseline to 36 month
|
3.4%
80/2331 • From baseline to 36 month
|
|
General disorders
Vomiting
|
3.1%
72/2334 • From baseline to 36 month
|
2.0%
46/2331 • From baseline to 36 month
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
69/2334 • From baseline to 36 month
|
3.3%
77/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.8%
66/2334 • From baseline to 36 month
|
3.5%
82/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
64/2334 • From baseline to 36 month
|
2.4%
57/2331 • From baseline to 36 month
|
|
Eye disorders
Cataract
|
2.7%
63/2334 • From baseline to 36 month
|
3.6%
84/2331 • From baseline to 36 month
|
|
Psychiatric disorders
Depression
|
2.7%
62/2334 • From baseline to 36 month
|
2.5%
58/2331 • From baseline to 36 month
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
60/2334 • From baseline to 36 month
|
2.7%
63/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
55/2334 • From baseline to 36 month
|
2.3%
54/2331 • From baseline to 36 month
|
|
Infections and infestations
Viral infection
|
2.3%
54/2334 • From baseline to 36 month
|
3.0%
70/2331 • From baseline to 36 month
|
|
Gastrointestinal disorders
Abdominal distension
|
2.3%
54/2334 • From baseline to 36 month
|
1.9%
44/2331 • From baseline to 36 month
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.3%
53/2334 • From baseline to 36 month
|
1.4%
33/2331 • From baseline to 36 month
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
47/2334 • From baseline to 36 month
|
1.8%
42/2331 • From baseline to 36 month
|
|
Infections and infestations
Sinusitis
|
2.0%
46/2334 • From baseline to 36 month
|
2.2%
52/2331 • From baseline to 36 month
|
|
Psychiatric disorders
Insomnia
|
1.9%
45/2334 • From baseline to 36 month
|
2.6%
60/2331 • From baseline to 36 month
|
|
General disorders
Edema peripheral
|
1.9%
44/2334 • From baseline to 36 month
|
2.7%
63/2331 • From baseline to 36 month
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.8%
42/2334 • From baseline to 36 month
|
2.0%
47/2331 • From baseline to 36 month
|
|
General disorders
Chest pain
|
1.6%
37/2334 • From baseline to 36 month
|
3.0%
69/2331 • From baseline to 36 month
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
35/2334 • From baseline to 36 month
|
2.1%
48/2331 • From baseline to 36 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60