A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Sponsor
Nordic Bioscience A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00525798
Collaborator
Novartis (Industry)
4,665
16
2
56
291.6
5.2
Study Details
Study Description
Brief Summary
The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4665 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Study Start Date
:
Mar 1, 2007
Actual Primary Completion Date
:
Aug 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 SMC021 - Oral Calcitonin |
Drug: SMC021 Oral calcitonin
0.8mg SMC021 - oral calcitonin, once daily
|
| Placebo Comparator: SMC021- Placebo SMC021 - placebo |
Drug: SMC021 Placebo
SMC021 - Placebo, once daily
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With New Vertebral Fractures [From baseline to month 36]
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.
Secondary Outcome Measures
- Number of Patients With Non-vertebral Fractures [From baseline to month 36]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Years
to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.
Exclusion Criteria:
-
BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
-
More than 2 prevalent vertebral fractures (Genant et al, 15).
-
If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
-
Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
-
BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | United Osteporosis Centers | Gainesville | Georgia | United States | 30501 |
| 2 | Michigan Bone & Mineral Clinic PC, | Detroit | Michigan | United States | 48236 |
| 3 | Oregon Osteoporosis Center | Portland | Oregon | United States | 97213 |
| 4 | CCBR Brazil | Rio de Janeiro | Brazil | 22271-100 | |
| 5 | CCBR China | Beijing | China | 102206 | |
| 6 | CCBR Czech | Pardubice | Czech Republic | 53002 | |
| 7 | CCBR Aalborg | Aalborg | Denmark | 9000 | |
| 8 | CCBR Ballerup | Ballerup | Denmark | 2750 | |
| 9 | CCBR Vejle | Vejle | Denmark | 7100 | |
| 10 | CCBR Estonia | Tallinn | Estonia | 10128 | |
| 11 | Hopital Edouard Herriot | Lyon | France | 69437 | |
| 12 | CCBR Hong Kong | Hong Kong | Hong Kong | ||
| 13 | Department of Internal Medicine, University of Florence | Florence | Italy | ||
| 14 | CCBR Lithuania | Vilnius | Lithuania | 10323 | |
| 15 | CCBR Poland | Warsaw | Poland | 04703 | |
| 16 | CCBR Romania | Bucharest | Romania | 030463 |
Sponsors and Collaborators
- Nordic Bioscience A/S
- Novartis
Investigators
- Study Chair: Bente J Riis, M.D., Nordic Bioscience A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00525798
Other Study ID Numbers:
- SMC021A2303
First Posted:
Sep 6, 2007
Last Update Posted:
Oct 29, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Nordic Bioscience A/S
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SMC021 | Placebo |
|---|---|---|
| Arm/Group Description | 1 tablet of 0,80 mg SMC021 daily | 1 tablet of placebo daily |
| Period Title: Overall Study | ||
| STARTED | 2334 | 2331 |
| COMPLETED | 1578 | 1732 |
| NOT COMPLETED | 756 | 599 |
Baseline Characteristics
| Arm/Group Title | SMC021 | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 1 tablet of 0,80 mg SMC021 daily | 1 tablet of placebo daily | Total of all reporting groups |
| Overall Participants | 2334 | 2331 | 4665 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
912
39.1%
|
860
36.9%
|
1772
38%
|
| >=65 years |
1422
60.9%
|
1471
63.1%
|
2893
62%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.5
(6.12)
|
67.0
(6.16)
|
66.8
(6.14)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2334
100%
|
2331
100%
|
4665
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
31
1.3%
|
30
1.3%
|
61
1.3%
|
| France |
2
0.1%
|
2
0.1%
|
4
0.1%
|
| Hong Kong |
74
3.2%
|
73
3.1%
|
147
3.2%
|
| Czech Republic |
230
9.9%
|
232
10%
|
462
9.9%
|
| Estonia |
167
7.2%
|
166
7.1%
|
333
7.1%
|
| Brazil |
492
21.1%
|
492
21.1%
|
984
21.1%
|
| Poland |
176
7.5%
|
176
7.6%
|
352
7.5%
|
| Lithuania |
149
6.4%
|
150
6.4%
|
299
6.4%
|
| Romania |
172
7.4%
|
171
7.3%
|
343
7.4%
|
| Denmark |
599
25.7%
|
598
25.7%
|
1197
25.7%
|
| Italy |
18
0.8%
|
17
0.7%
|
35
0.8%
|
| China |
224
9.6%
|
224
9.6%
|
448
9.6%
|
Outcome Measures
| Title | Number of Patients With New Vertebral Fractures |
|---|---|
| Description | 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. |
| Time Frame | From baseline to month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | SMC021 | Placebo |
|---|---|---|
| Arm/Group Description | 1 tablet of 0,80 mg SMC021 daily | 1 tablet of placebo daily |
| Measure Participants | 2064 | 2125 |
| Number [Participants] |
94
4%
|
99
4.2%
|
| Title | Number of Patients With Non-vertebral Fractures |
|---|---|
| Description | 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. |
| Time Frame | From baseline to month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| all randomized patients |
| Arm/Group Title | SMC021 | Placebo |
|---|---|---|
| Arm/Group Description | 1 tablet of 0,80 mg SMC021 daily | 1 tablet of placebo daily |
| Measure Participants | 2334 | 2331 |
| Number [Participants] |
75
3.2%
|
82
3.5%
|
Adverse Events
| Time Frame | From baseline to 36 month | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SMC021 | Placebo | ||
| Arm/Group Description | 1 tablet of 0,80 mg SMC021 daily | 1 tablet of placebo daily | ||
All Cause Mortality |
||||
| SMC021 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SMC021 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 340/2334 (14.6%) | 378/2331 (16.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Iron deficiency anaemia | 0/2334 (0%) | 1/2331 (0%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 10/2334 (0.4%) | 8/2331 (0.3%) | ||
| Acute myocardial infarction | 6/2334 (0.3%) | 3/2331 (0.1%) | ||
| Coronary artery disease | 5/2334 (0.2%) | 5/2331 (0.2%) | ||
| Angina pectoris | 5/2334 (0.2%) | 4/2331 (0.2%) | ||
| Myocardial ischaemia | 4/2334 (0.2%) | 3/2331 (0.1%) | ||
| Angina unstable | 3/2334 (0.1%) | 6/2331 (0.3%) | ||
| Myocardial infarction | 3/2334 (0.1%) | 4/2331 (0.2%) | ||
| Arrhytmia | 3/2334 (0.1%) | 1/2331 (0%) | ||
| Cardiac failure | 3/2334 (0.1%) | 1/2331 (0%) | ||
| Cardiac failure congestive | 3/2334 (0.1%) | 0/2331 (0%) | ||
| Atrial flutter | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Arteriosclerosis coronary artery | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Aortic valve stenosis | 1/2334 (0%) | 1/2331 (0%) | ||
| Sick sinus syndrome | 1/2334 (0%) | 1/2331 (0%) | ||
| Bradycardia | 1/2334 (0%) | 0/2331 (0%) | ||
| Cardiovascular insufficiency | 1/2334 (0%) | 0/2331 (0%) | ||
| Pericarditis | 1/2334 (0%) | 0/2331 (0%) | ||
| Tachycardia | 1/2334 (0%) | 0/2331 (0%) | ||
| Ventricular extrasystoles | 1/2334 (0%) | 0/2331 (0%) | ||
| Acute coronary syndrome | 0/2334 (0%) | 1/2331 (0%) | ||
| Aortic valve disease | 0/2334 (0%) | 1/2331 (0%) | ||
| Bundle branch block left | 0/2334 (0%) | 1/2331 (0%) | ||
| Cardiomyopathy | 0/2334 (0%) | 1/2331 (0%) | ||
| Coronary artery dilatation | 0/2334 (0%) | 1/2331 (0%) | ||
| Coronary artery stenosis | 0/2334 (0%) | 1/2331 (0%) | ||
| Coronary artery thrombosis | 0/2334 (0%) | 1/2331 (0%) | ||
| Hypertrophic cardiomyopathy | 0/2334 (0%) | 1/2331 (0%) | ||
| Mitral valve incompetence | 0/2334 (0%) | 1/2331 (0%) | ||
| Supraventricular tachycardia | 0/2334 (0%) | 1/2331 (0%) | ||
| Ventricular dysfunction | 0/2334 (0%) | 1/2331 (0%) | ||
| Ventricular failure | 0/2334 (0%) | 1/2331 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Hereditary haemorrhagic telangiectasia | 1/2334 (0%) | 0/2331 (0%) | ||
| Abdominal wall anomaly | 0/2334 (0%) | 1/2331 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 1/2334 (0%) | 3/2331 (0.1%) | ||
| Deafness | 1/2334 (0%) | 0/2331 (0%) | ||
| Meniere´s disease | 1/2334 (0%) | 0/2331 (0%) | ||
| Otosclerosis | 1/2334 (0%) | 0/2331 (0%) | ||
| Deafness unilateral | 0/2334 (0%) | 1/2331 (0%) | ||
| Vertigo positional | 0/2334 (0%) | 1/2331 (0%) | ||
| Vestibular ataxia | 0/2334 (0%) | 1/2331 (0%) | ||
| Endocrine disorders | ||||
| Goitre | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Hypothyroidism | 1/2334 (0%) | 0/2331 (0%) | ||
| Thyroid disorder | 1/2334 (0%) | 0/2331 (0%) | ||
| Hypothyroidic goitre | 0/2334 (0%) | 1/2331 (0%) | ||
| Eye disorders | ||||
| Cataract | 6/2334 (0.3%) | 3/2331 (0.1%) | ||
| Glaucoma | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Retinal detachment | 1/2334 (0%) | 1/2331 (0%) | ||
| Macular degeneration | 1/2334 (0%) | 0/2331 (0%) | ||
| Maculopathy | 1/2334 (0%) | 0/2331 (0%) | ||
| Scleritis | 1/2334 (0%) | 0/2331 (0%) | ||
| Eye disorder | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Angle closure glaucoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Optic atrophy | 0/2334 (0%) | 1/2331 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/2334 (0.1%) | 2/2331 (0.1%) | ||
| Inguinal hernia | 3/2334 (0.1%) | 0/2331 (0%) | ||
| Abdominal hernia | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Dyspepsia | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Ileus | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Haemorrhoids | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Intestinal obstruction | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Colonic polyp | 1/2334 (0%) | 4/2331 (0.2%) | ||
| Gastrointestinal haemorrhage | 1/2334 (0%) | 2/2331 (0.1%) | ||
| Colitis | 1/2334 (0%) | 1/2331 (0%) | ||
| Diarrhoea | 1/2334 (0%) | 1/2331 (0%) | ||
| Duodenal ulcer | 1/2334 (0%) | 1/2331 (0%) | ||
| Femoral hernia | 1/2334 (0%) | 1/2331 (0%) | ||
| Pancreatitis acute | 1/2334 (0%) | 1/2331 (0%) | ||
| Coeliac disease | 1/2334 (0%) | 0/2331 (0%) | ||
| Colitis ulcerative | 1/2334 (0%) | 0/2331 (0%) | ||
| Enterocele | 1/2334 (0%) | 0/2331 (0%) | ||
| Food poisoning | 1/2334 (0%) | 0/2331 (0%) | ||
| Gastric ulcer | 1/2334 (0%) | 0/2331 (0%) | ||
| Gastrointestinal disorder | 1/2334 (0%) | 0/2331 (0%) | ||
| Gastrointestinal inflammation | 1/2334 (0%) | 0/2331 (0%) | ||
| Hiatus hernia | 1/2334 (0%) | 0/2331 (0%) | ||
| Lumbar hernia | 1/2334 (0%) | 0/2331 (0%) | ||
| Mechanical ileus | 1/2334 (0%) | 0/2331 (0%) | ||
| Melaena | 1/2334 (0%) | 0/2331 (0%) | ||
| Small intestinal obstruction | 1/2334 (0%) | 0/2331 (0%) | ||
| Abdominal pain upper | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Constipation | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Gastric ulcer haemorrhage | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Abdominal discomfort | 0/2334 (0%) | 1/2331 (0%) | ||
| Abdominal pain lower | 0/2334 (0%) | 1/2331 (0%) | ||
| Gastrooesophageal reflux disease | 0/2334 (0%) | 1/2331 (0%) | ||
| Intussusception | 0/2334 (0%) | 1/2331 (0%) | ||
| Oesophagitis | 0/2334 (0%) | 1/2331 (0%) | ||
| Rectal polyp | 0/2334 (0%) | 1/2331 (0%) | ||
| Umbilical hernia, obstructive | 0/2334 (0%) | 1/2331 (0%) | ||
| General disorders | ||||
| Chest pain | 3/2334 (0.1%) | 8/2331 (0.3%) | ||
| Death | 3/2334 (0.1%) | 2/2331 (0.1%) | ||
| Pyrexia | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Adverse drug reaction | 1/2334 (0%) | 0/2331 (0%) | ||
| Device occlusion | 1/2334 (0%) | 0/2331 (0%) | ||
| Oedema peripheral | 1/2334 (0%) | 0/2331 (0%) | ||
| Thrombosis in device | 1/2334 (0%) | 0/2331 (0%) | ||
| Chest discomfort | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Accidental death | 0/2334 (0%) | 1/2331 (0%) | ||
| Sudden cardiac death | 0/2334 (0%) | 1/2331 (0%) | ||
| Ulcer | 0/2334 (0%) | 1/2331 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 19/2334 (0.8%) | 9/2331 (0.4%) | ||
| Cholecystitis acute | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Cholecystitis chronic | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Gallbladder polyp | 1/2334 (0%) | 0/2331 (0%) | ||
| Bile duct stone | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Biliary colic | 0/2334 (0%) | 1/2331 (0%) | ||
| Cholecystitis | 0/2334 (0%) | 1/2331 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 0/2334 (0%) | 1/2331 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 12/2334 (0.5%) | 11/2331 (0.5%) | ||
| Diverticulitis | 3/2334 (0.1%) | 3/2331 (0.1%) | ||
| Appendicitis | 3/2334 (0.1%) | 1/2331 (0%) | ||
| Urinary tract infection | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Bronchitis | 1/2334 (0%) | 3/2331 (0.1%) | ||
| Gastroenteritis | 1/2334 (0%) | 2/2331 (0.1%) | ||
| Pyelonephritis | 1/2334 (0%) | 2/2331 (0.1%) | ||
| Septic shock | 1/2334 (0%) | 1/2331 (0%) | ||
| Urosepsis | 1/2334 (0%) | 1/2331 (0%) | ||
| Bacterial infection | 1/2334 (0%) | 0/2331 (0%) | ||
| Cystitis | 1/2334 (0%) | 0/2331 (0%) | ||
| Encephalitis viral | 1/2334 (0%) | 0/2331 (0%) | ||
| Gallbladder empyema | 1/2334 (0%) | 0/2331 (0%) | ||
| Gangrene | 1/2334 (0%) | 0/2331 (0%) | ||
| Gastroenteritis salmonella | 1/2334 (0%) | 0/2331 (0%) | ||
| Hepatitis C | 1/2334 (0%) | 0/2331 (0%) | ||
| Parainfluenzae virus infection | 1/2334 (0%) | 0/2331 (0%) | ||
| Perineal infection | 1/2334 (0%) | 0/2331 (0%) | ||
| Pyelonephritis acute | 1/2334 (0%) | 0/2331 (0%) | ||
| Tuberculosis | 1/2334 (0%) | 0/2331 (0%) | ||
| Erysipelas | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Herpes zoster | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Bronchopneumonia | 0/2334 (0%) | 1/2331 (0%) | ||
| Infection | 0/2334 (0%) | 1/2331 (0%) | ||
| Neurological infection | 0/2334 (0%) | 1/2331 (0%) | ||
| Paronychia | 0/2334 (0%) | 1/2331 (0%) | ||
| Pelvic inflammatory disease | 0/2334 (0%) | 1/2331 (0%) | ||
| Pyometra | 0/2334 (0%) | 1/2331 (0%) | ||
| Salmonellosis | 0/2334 (0%) | 1/2331 (0%) | ||
| Sepsis | 0/2334 (0%) | 1/2331 (0%) | ||
| Vaginal infection | 0/2334 (0%) | 1/2331 (0%) | ||
| Viral pericarditis | 0/2334 (0%) | 1/2331 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Wrist fracture | 8/2334 (0.3%) | 8/2331 (0.3%) | ||
| Femoral neck fracture | 5/2334 (0.2%) | 3/2331 (0.1%) | ||
| Humurus fracture | 4/2334 (0.2%) | 4/2331 (0.2%) | ||
| Femur fracture | 3/2334 (0.1%) | 9/2331 (0.4%) | ||
| Concussion | 3/2334 (0.1%) | 0/2331 (0%) | ||
| Tibia fracture | 2/2334 (0.1%) | 3/2331 (0.1%) | ||
| Ankle fracture | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Radius fracture | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Hip fracture | 1/2334 (0%) | 4/2331 (0.2%) | ||
| Contusion | 1/2334 (0%) | 1/2331 (0%) | ||
| Joint dislocation | 1/2334 (0%) | 1/2331 (0%) | ||
| Multiple fractures | 1/2334 (0%) | 1/2331 (0%) | ||
| Spinal fracture | 1/2334 (0%) | 1/2331 (0%) | ||
| Thoracic vertebral fracture | 1/2334 (0%) | 1/2331 (0%) | ||
| Traumatic brain injury | 1/2334 (0%) | 1/2331 (0%) | ||
| Alcohol poisoning | 1/2334 (0%) | 0/2331 (0%) | ||
| Avulsion fracture | 1/2334 (0%) | 0/2331 (0%) | ||
| Burns secound degree | 1/2334 (0%) | 0/2331 (0%) | ||
| Burns third degree | 1/2334 (0%) | 0/2331 (0%) | ||
| Face injury | 1/2334 (0%) | 0/2331 (0%) | ||
| Forearm fracture | 1/2334 (0%) | 0/2331 (0%) | ||
| Jaw fracture | 1/2334 (0%) | 0/2331 (0%) | ||
| Limb traumatic amputation | 1/2334 (0%) | 0/2331 (0%) | ||
| Muscle injury | 1/2334 (0%) | 0/2331 (0%) | ||
| Perineal laceration | 1/2334 (0%) | 0/2331 (0%) | ||
| Road traffic accident | 1/2334 (0%) | 0/2331 (0%) | ||
| Toxicity to various agents | 1/2334 (0%) | 0/2331 (0%) | ||
| Ulna fracture | 1/2334 (0%) | 0/2331 (0%) | ||
| Pelvic fracture | 0/2334 (0%) | 3/2331 (0.1%) | ||
| Upper limb fracture | 0/2334 (0%) | 3/2331 (0.1%) | ||
| Lumbar vertebral fracture | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Meniscus lesion | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Rib fracture | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Wound | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Fibula fracture | 0/2334 (0%) | 1/2331 (0%) | ||
| Foot fracture | 0/2334 (0%) | 1/2331 (0%) | ||
| Limb injury | 0/2334 (0%) | 1/2331 (0%) | ||
| Lower limb fracture | 0/2334 (0%) | 1/2331 (0%) | ||
| Patella fracture | 0/2334 (0%) | 1/2331 (0%) | ||
| Post procedural haematoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Post procedural haemorrhage | 0/2334 (0%) | 1/2331 (0%) | ||
| Postoperative hernia | 0/2334 (0%) | 1/2331 (0%) | ||
| Postpericardiotomy syndrome | 0/2334 (0%) | 1/2331 (0%) | ||
| Tendon injury | 0/2334 (0%) | 1/2331 (0%) | ||
| Tendon rupture | 0/2334 (0%) | 1/2331 (0%) | ||
| Investigations | ||||
| Electrocardiogram QT prolonged | 2/2334 (0.1%) | 1/2331 (0%) | ||
| International normalised ratio increased | 1/2334 (0%) | 0/2331 (0%) | ||
| Arteriogram coronary | 0/2334 (0%) | 1/2331 (0%) | ||
| Arthroscopy | 0/2334 (0%) | 1/2331 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetes mellitus | 1/2334 (0%) | 3/2331 (0.1%) | ||
| Dehydration | 1/2334 (0%) | 1/2331 (0%) | ||
| Type 2 diabetes mellitus | 0/2334 (0%) | 1/2331 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Osteoarthritis | 19/2334 (0.8%) | 17/2331 (0.7%) | ||
| Arthralgia | 3/2334 (0.1%) | 4/2331 (0.2%) | ||
| Spinal column stenosis | 3/2334 (0.1%) | 1/2331 (0%) | ||
| Foot deformity | 2/2334 (0.1%) | 5/2331 (0.2%) | ||
| Back pain | 2/2334 (0.1%) | 4/2331 (0.2%) | ||
| Osteonecrosis | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Pseudarthrosis | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Rheumatoid arthritis | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Intervertebral disc protrusion | 1/2334 (0%) | 6/2331 (0.3%) | ||
| Arthritis | 1/2334 (0%) | 1/2331 (0%) | ||
| Fibromyalgia | 1/2334 (0%) | 0/2331 (0%) | ||
| Fistula | 1/2334 (0%) | 0/2331 (0%) | ||
| Haemarthrosis | 1/2334 (0%) | 0/2331 (0%) | ||
| Intervertebral disc disorder | 1/2334 (0%) | 0/2331 (0%) | ||
| Synovial cyst | 1/2334 (0%) | 0/2331 (0%) | ||
| Bone pain | 0/2334 (0%) | 1/2331 (0%) | ||
| Bursitis | 0/2334 (0%) | 1/2331 (0%) | ||
| Mobility decreased | 0/2334 (0%) | 1/2331 (0%) | ||
| Periarthritis | 0/2334 (0%) | 1/2331 (0%) | ||
| Rotator cuff syndrome | 0/2334 (0%) | 1/2331 (0%) | ||
| Spondylolisthesis | 0/2334 (0%) | 1/2331 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer | 14/2334 (0.6%) | 12/2331 (0.5%) | ||
| Rectal cancer | 3/2334 (0.1%) | 3/2331 (0.1%) | ||
| Lung neoplasm malignant | 2/2334 (0.1%) | 4/2331 (0.2%) | ||
| Malignant melanoma | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Chronic lymphocytic leukaemia | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Thyroid cancer | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Lymphoma | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Multiple myeloma | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Ovarian cancer | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Skin cancer | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Adult T-cell lymphoma/leukaemia | 1/2334 (0%) | 0/2331 (0%) | ||
| B-cell lymphoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Basal cell carcinoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Benign renal neoplasm | 1/2334 (0%) | 0/2331 (0%) | ||
| Bronchial carcinoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Cervix carcinoma stage 0 | 1/2334 (0%) | 0/2331 (0%) | ||
| Cervix neoplasm | 1/2334 (0%) | 0/2331 (0%) | ||
| EndometrÃal cancer | 1/2334 (0%) | 0/2331 (0%) | ||
| Lipoma of breast | 1/2334 (0%) | 0/2331 (0%) | ||
| Lung adenocarcinoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Lung cancer metastatic | 1/2334 (0%) | 0/2331 (0%) | ||
| Metastasis | 1/2334 (0%) | 0/2331 (0%) | ||
| Nasal cavity cancer | 1/2334 (0%) | 0/2331 (0%) | ||
| Ovarian germ cell teratoma benign | 1/2334 (0%) | 0/2331 (0%) | ||
| Renal cell carcinoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Renal oncocytoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Squamos cell carcinoma of skin | 1/2334 (0%) | 0/2331 (0%) | ||
| Uterine carcinoma in situ | 1/2334 (0%) | 0/2331 (0%) | ||
| Uterine leiomyoma | 1/2334 (0%) | 0/2331 (0%) | ||
| Bladder cancer | 0/2334 (0%) | 3/2331 (0.1%) | ||
| Vulval cancer | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Adenocarcinoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Adenoma benign | 0/2334 (0%) | 1/2331 (0%) | ||
| Adrenocortical carcinoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Benign ovarian tumour | 0/2334 (0%) | 1/2331 (0%) | ||
| Breast cancer metastatic | 0/2334 (0%) | 1/2331 (0%) | ||
| Carcinoid tumour of the stomach | 0/2334 (0%) | 1/2331 (0%) | ||
| Cervix carcinoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Cervix carcinoma stage III | 0/2334 (0%) | 1/2331 (0%) | ||
| Colon cancer | 0/2334 (0%) | 1/2331 (0%) | ||
| Gastrooesophageal cancer | 0/2334 (0%) | 1/2331 (0%) | ||
| Lung neoplasm | 0/2334 (0%) | 1/2331 (0%) | ||
| Meningioma | 0/2334 (0%) | 1/2331 (0%) | ||
| Mucoepidermoid carcinoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Ovarian cancer metastatic | 0/2334 (0%) | 1/2331 (0%) | ||
| Pancreatic carcinoma | 0/2334 (0%) | 1/2331 (0%) | ||
| Rectosigmoid cancer | 0/2334 (0%) | 1/2331 (0%) | ||
| Renal cancer | 0/2334 (0%) | 1/2331 (0%) | ||
| Spinal haemangioma | 0/2334 (0%) | 1/2331 (0%) | ||
| Thyroid neoplasm | 0/2334 (0%) | 1/2331 (0%) | ||
| Uterine cancer | 0/2334 (0%) | 1/2331 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 10/2334 (0.4%) | 8/2331 (0.3%) | ||
| Ischaemic stroke | 5/2334 (0.2%) | 5/2331 (0.2%) | ||
| Syncope | 3/2334 (0.1%) | 4/2331 (0.2%) | ||
| Transient ischaemic attack | 2/2334 (0.1%) | 9/2331 (0.4%) | ||
| Headache | 1/2334 (0%) | 3/2331 (0.1%) | ||
| Reversible ischaemic neurological deficit | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Dizziness | 1/2334 (0%) | 1/2331 (0%) | ||
| Loss of consciousness | 1/2334 (0%) | 1/2331 (0%) | ||
| Brain stem infarction | 1/2334 (0%) | 0/2331 (0%) | ||
| Brain stem thrombosis | 1/2334 (0%) | 0/2331 (0%) | ||
| Cervicobrachial syndrome | 1/2334 (0%) | 0/2331 (0%) | ||
| Diabetic neuropathy | 1/2334 (0%) | 0/2331 (0%) | ||
| Neuropathy peripheral | 1/2334 (0%) | 0/2331 (0%) | ||
| Paraesthesia | 1/2334 (0%) | 0/2331 (0%) | ||
| Subarachnoid haemorrhage | 1/2334 (0%) | 0/2331 (0%) | ||
| Trigeminal neuralgia | 1/2334 (0%) | 0/2331 (0%) | ||
| Cerebral infarction | 0/2334 (0%) | 4/2331 (0.2%) | ||
| Cerebral thrombosis | 0/2334 (0%) | 3/2331 (0.1%) | ||
| Amnesia | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Epilepsy | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Haemorrhagic stroke | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Hypertensive encephalopathy | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Carotid artery stenosis | 0/2334 (0%) | 1/2331 (0%) | ||
| Cerebral haemorrhage | 0/2334 (0%) | 1/2331 (0%) | ||
| Cerebrovascular disorder | 0/2334 (0%) | 1/2331 (0%) | ||
| Convulsion | 0/2334 (0%) | 1/2331 (0%) | ||
| Hypoaesthesia | 0/2334 (0%) | 1/2331 (0%) | ||
| IIIrd nerve paralysis | 0/2334 (0%) | 1/2331 (0%) | ||
| Lumbar radiculopathy | 0/2334 (0%) | 1/2331 (0%) | ||
| Paralysis | 0/2334 (0%) | 1/2331 (0%) | ||
| Parkinsonism | 0/2334 (0%) | 1/2331 (0%) | ||
| Sciatica | 0/2334 (0%) | 1/2331 (0%) | ||
| Spinal cord compression | 0/2334 (0%) | 1/2331 (0%) | ||
| VIIth nerve paralysis | 0/2334 (0%) | 1/2331 (0%) | ||
| Vascular dementia | 0/2334 (0%) | 1/2331 (0%) | ||
| Vertebral artery stenosis | 0/2334 (0%) | 1/2331 (0%) | ||
| Psychiatric disorders | ||||
| Depression | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Insomnia | 1/2334 (0%) | 0/2331 (0%) | ||
| Renal and urinary disorders | ||||
| Urinary incontinence | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Cystitis noninfective | 1/2334 (0%) | 1/2331 (0%) | ||
| Nephrolithiasis | 1/2334 (0%) | 1/2331 (0%) | ||
| Renal cyst | 1/2334 (0%) | 1/2331 (0%) | ||
| Bladder prolapse | 1/2334 (0%) | 0/2331 (0%) | ||
| Bladder disorder | 0/2334 (0%) | 1/2331 (0%) | ||
| Calculus ureteric | 0/2334 (0%) | 1/2331 (0%) | ||
| Haematuria | 0/2334 (0%) | 1/2331 (0%) | ||
| Renal colic | 0/2334 (0%) | 1/2331 (0%) | ||
| Renal failure | 0/2334 (0%) | 1/2331 (0%) | ||
| Urethral caruncle | 0/2334 (0%) | 1/2331 (0%) | ||
| Urethral polyp | 0/2334 (0%) | 1/2331 (0%) | ||
| Urinary bladder polyp | 0/2334 (0%) | 1/2331 (0%) | ||
| Urinary retention | 0/2334 (0%) | 1/2331 (0%) | ||
| Reproductive system and breast disorders | ||||
| Cystocele | 2/2334 (0.1%) | 4/2331 (0.2%) | ||
| Uterine polyp | 2/2334 (0.1%) | 3/2331 (0.1%) | ||
| Rectocele | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Vaginal haemorrhage | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Uterine prolapse | 1/2334 (0%) | 5/2331 (0.2%) | ||
| Vaginal prolapse | 1/2334 (0%) | 2/2331 (0.1%) | ||
| Endometrial disorder | 1/2334 (0%) | 0/2331 (0%) | ||
| Hydrometra | 1/2334 (0%) | 0/2331 (0%) | ||
| Breast enlargement | 0/2334 (0%) | 1/2331 (0%) | ||
| Genital disorder female | 0/2334 (0%) | 1/2331 (0%) | ||
| Ovarian cyst | 0/2334 (0%) | 1/2331 (0%) | ||
| Uterine haemorrhage | 0/2334 (0%) | 1/2331 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 4/2334 (0.2%) | 1/2331 (0%) | ||
| Dyspnoea | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Chronic obstructive pulmonary disease | 1/2334 (0%) | 2/2331 (0.1%) | ||
| Pulmonary embolism | 1/2334 (0%) | 1/2331 (0%) | ||
| Laryngeal oedema | 1/2334 (0%) | 0/2331 (0%) | ||
| Pleural effusion | 1/2334 (0%) | 0/2331 (0%) | ||
| Pleurisy | 1/2334 (0%) | 0/2331 (0%) | ||
| Pneumothorax | 0/2334 (0%) | 3/2331 (0.1%) | ||
| Acute respiratory failure | 0/2334 (0%) | 1/2331 (0%) | ||
| Bronchitis chronic | 0/2334 (0%) | 1/2331 (0%) | ||
| Haemoptysis | 0/2334 (0%) | 1/2331 (0%) | ||
| Laryngeal polyp | 0/2334 (0%) | 1/2331 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Eczema | 1/2334 (0%) | 0/2331 (0%) | ||
| Actinic keratosis | 0/2334 (0%) | 1/2331 (0%) | ||
| Social circumstances | ||||
| Breast prothesis user | 0/2334 (0%) | 1/2331 (0%) | ||
| Joint prothesis user | 0/2334 (0%) | 1/2331 (0%) | ||
| Surgical and medical procedures | ||||
| Knee arthroplasty | 3/2334 (0.1%) | 3/2331 (0.1%) | ||
| Hip arthroplasty | 3/2334 (0.1%) | 2/2331 (0.1%) | ||
| Varicose vein operation | 3/2334 (0.1%) | 0/2331 (0%) | ||
| Appendicectomy | 2/2334 (0.1%) | 2/2331 (0.1%) | ||
| Mastectomy | 1/2334 (0%) | 1/2331 (0%) | ||
| Wrist surgery | 1/2334 (0%) | 1/2331 (0%) | ||
| Bone operation | 1/2334 (0%) | 0/2331 (0%) | ||
| Oophorectomy bilateral | 1/2334 (0%) | 0/2331 (0%) | ||
| Vaginaplasty | 1/2334 (0%) | 0/2331 (0%) | ||
| Vascular graft | 1/2334 (0%) | 0/2331 (0%) | ||
| Cataract operation | 0/2334 (0%) | 7/2331 (0.3%) | ||
| Aortic bypass | 0/2334 (0%) | 1/2331 (0%) | ||
| Breast prothesis removal | 0/2334 (0%) | 1/2331 (0%) | ||
| Cardiac pacemaker battery replacement | 0/2334 (0%) | 1/2331 (0%) | ||
| Cardiac pacemaker insertion | 0/2334 (0%) | 1/2331 (0%) | ||
| Cardiac pacemaker replacement | 0/2334 (0%) | 1/2331 (0%) | ||
| Cholecystectomy | 0/2334 (0%) | 1/2331 (0%) | ||
| Fracture reduction | 0/2334 (0%) | 1/2331 (0%) | ||
| Gallbladder operation | 0/2334 (0%) | 1/2331 (0%) | ||
| Genitourinary operation | 0/2334 (0%) | 1/2331 (0%) | ||
| Haemorrhoid operation | 0/2334 (0%) | 1/2331 (0%) | ||
| Hospitalisation | 0/2334 (0%) | 1/2331 (0%) | ||
| Osteosynthesis | 0/2334 (0%) | 1/2331 (0%) | ||
| Percutaneous coronary intervention | 0/2334 (0%) | 1/2331 (0%) | ||
| Radical hysterectomy | 0/2334 (0%) | 1/2331 (0%) | ||
| Shoulder operation | 0/2334 (0%) | 1/2331 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 5/2334 (0.2%) | 4/2331 (0.2%) | ||
| Varicose vein | 3/2334 (0.1%) | 2/2331 (0.1%) | ||
| Arteriosclerosis | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Deep vein thrombosis | 2/2334 (0.1%) | 1/2331 (0%) | ||
| Femoral arterial stenosis | 2/2334 (0.1%) | 0/2331 (0%) | ||
| Aneurysm | 1/2334 (0%) | 0/2331 (0%) | ||
| Arterial occlusive disease | 1/2334 (0%) | 0/2331 (0%) | ||
| Circulatory collapse | 1/2334 (0%) | 0/2331 (0%) | ||
| Hypotension | 1/2334 (0%) | 0/2331 (0%) | ||
| Peripheral ischaemia | 1/2334 (0%) | 0/2331 (0%) | ||
| Temporal arteritis | 1/2334 (0%) | 0/2331 (0%) | ||
| Thrombophlebitis superficial | 1/2334 (0%) | 0/2331 (0%) | ||
| Hypertensive crisis | 0/2334 (0%) | 2/2331 (0.1%) | ||
| Aortic occlusion | 0/2334 (0%) | 1/2331 (0%) | ||
| Arteriosclerosis obliterans | 0/2334 (0%) | 1/2331 (0%) | ||
| Orthostatic hypotension | 0/2334 (0%) | 1/2331 (0%) | ||
| Vasculitis | 0/2334 (0%) | 1/2331 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| SMC021 | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2152/2334 (92.2%) | 2141/2331 (91.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 69/2334 (3%) | 77/2331 (3.3%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 60/2334 (2.6%) | 63/2331 (2.7%) | ||
| Eye disorders | ||||
| Cataract | 63/2334 (2.7%) | 84/2331 (3.6%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 357/2334 (15.3%) | 117/2331 (5%) | ||
| Dyspepsia | 228/2334 (9.8%) | 129/2331 (5.5%) | ||
| Constipation | 165/2334 (7.1%) | 172/2331 (7.4%) | ||
| Diarrhea | 157/2334 (6.7%) | 120/2331 (5.1%) | ||
| Abdominal pain upper | 153/2334 (6.6%) | 107/2331 (4.6%) | ||
| Abdominal discomfort | 114/2334 (4.9%) | 57/2331 (2.4%) | ||
| Gastritis | 64/2334 (2.7%) | 57/2331 (2.4%) | ||
| Abdominal distension | 54/2334 (2.3%) | 44/2331 (1.9%) | ||
| General disorders | ||||
| Vomiting | 72/2334 (3.1%) | 46/2331 (2%) | ||
| Edema peripheral | 44/2334 (1.9%) | 63/2331 (2.7%) | ||
| Chest pain | 37/2334 (1.6%) | 69/2331 (3%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 262/2334 (11.2%) | 269/2331 (11.5%) | ||
| Influenza | 133/2334 (5.7%) | 160/2331 (6.9%) | ||
| Bronchitis | 104/2334 (4.5%) | 127/2331 (5.4%) | ||
| Pneumonia | 102/2334 (4.4%) | 108/2331 (4.6%) | ||
| Cystitis | 100/2334 (4.3%) | 96/2331 (4.1%) | ||
| Urinary tract infection | 88/2334 (3.8%) | 95/2331 (4.1%) | ||
| Viral infection | 54/2334 (2.3%) | 70/2331 (3%) | ||
| Sinusitis | 46/2334 (2%) | 52/2331 (2.2%) | ||
| Upper respiratory tract infection | 35/2334 (1.5%) | 48/2331 (2.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 55/2334 (2.4%) | 54/2331 (2.3%) | ||
| Wrist fracture | 42/2334 (1.8%) | 47/2331 (2%) | ||
| Metabolism and nutrition disorders | ||||
| Hypercholesterolemia | 137/2334 (5.9%) | 149/2331 (6.4%) | ||
| Hypertriglyceridemia | 118/2334 (5.1%) | 120/2331 (5.1%) | ||
| Hypocalcemia | 53/2334 (2.3%) | 33/2331 (1.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 311/2334 (13.3%) | 339/2331 (14.5%) | ||
| Arthralgia | 284/2334 (12.2%) | 320/2331 (13.7%) | ||
| Pain in extremity | 136/2334 (5.8%) | 186/2331 (8%) | ||
| Osteoarthritis | 129/2334 (5.5%) | 142/2331 (6.1%) | ||
| Musculoskeletal pain | 66/2334 (2.8%) | 82/2331 (3.5%) | ||
| Muscle spasms | 47/2334 (2%) | 42/2331 (1.8%) | ||
| Nervous system disorders | ||||
| Dizziness | 120/2334 (5.1%) | 105/2331 (4.5%) | ||
| Headache | 72/2334 (3.1%) | 80/2331 (3.4%) | ||
| Psychiatric disorders | ||||
| Depression | 62/2334 (2.7%) | 58/2331 (2.5%) | ||
| Insomnia | 45/2334 (1.9%) | 60/2331 (2.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 79/2334 (3.4%) | 88/2331 (3.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 123/2334 (5.3%) | 14/2331 (0.6%) | ||
| Vascular disorders | ||||
| Hot flush | 263/2334 (11.3%) | 41/2331 (1.8%) | ||
| Hypertension | 238/2334 (10.2%) | 267/2331 (11.5%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Bente Juul Riis |
|---|---|
| Organization | Nordic Bioscience |
| Phone | +45 22901317 |
| bjr@nordicbioscience.com |
Responsible Party:
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00525798
Other Study ID Numbers:
- SMC021A2303
First Posted:
Sep 6, 2007
Last Update Posted:
Oct 29, 2012
Last Verified:
Oct 1, 2012