NET-PD LS-1 Creatine in Parkinson's Disease
Sponsor
University of Rochester (Other)
Overall Status
Terminated
CT.gov ID
NCT00449865
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
1,741
50
2
86
34.8
0.4
Study Details
Study Description
Brief Summary
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.
This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1741 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)
Study Start Date
:
Mar 1, 2007
Actual Primary Completion Date
:
Sep 1, 2013
Actual Study Completion Date
:
May 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Other: placebo
an inactive substance
|
| Active Comparator: creatine
|
Drug: creatine
Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.
The study is comparing creatine 5 grams twice daily with placebo.
|
Outcome Measures
Primary Outcome Measures
- The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years. [Change from baseline to 5 YEARS]
All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Willing and able to give informed consent and willing to commit to long-term follow-up
-
PD (asymmetric features including slowness (bradykinesia) plus resting tremor and/or rigidity) within 5 years of diagnosis
-
Treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not more than 2 years.
Exclusion Criteria:
-
Use of creatine 14 days prior to baseline or during the study
-
History of known hypersensitivity or intolerability to creatine
-
Any unstable or clinically significant condition that would impair the subject's ability to comply with long term study follow-up
-
Other know or suspected causes of parkinsonism (e.g. metabolic, drug induced, etc.), or any significant features suggestive of a diagnosis of atypical parkinsonism.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Of Alabama, Birmingham, 350 Sparks Center, 1720 7th Avenue South | Birmingham | Alabama | United States | 35233 |
| 2 | Barrow Neurological Clinics At, St Joseph's Hospital & Medical Center, 500 West Thomas Road Suite 720, | Phoenix | Arizona | United States | 85013 |
| 3 | Parkinson's & Movement Disorder Institute, 9940 Talbert Avenue, Suite 204, | Fountain Valley | California | United States | 92708 |
| 4 | University Of Southern California, Healthcare Consultation Building II, 1520 San Pablo Street Suite 3000 | Los Angeles | California | United States | 90033 |
| 5 | University Of California San Francisco, Parkinson's Disease Clinic And Research Cen, 505 Parnassus Avenue M-798 | San Francisco | California | United States | 94143-0114 |
| 6 | The Parkinson's Institute, 675 Almanor Avenue | Sunnyvale | California | United States | 94085 |
| 7 | University Of Colorado Health Sciences Ctr, 4200 East 9th Avenue Campus Box C238, Department Of Clinical Pharmacy | Denver | Colorado | United States | 80262 |
| 8 | Neurodegenerative Disorders, 60 Temple Street Suite 8b | New Haven | Connecticut | United States | 06510 |
| 9 | VA Medical Center, 1601 Southwest Archer Road, Neurology Service (151) | Gainesville | Florida | United States | 32608 |
| 10 | University Of Florida, Mcknight Brain Institute, 100 South Newell Drive Room L3-100 | Gainesville | Florida | United States | 32610 |
| 11 | University Of Florida Jacksonville, 580 West 8th Street, Tower 1 8th Floor, | Jacksonville | Florida | United States | 32209 |
| 12 | University Of Miami, 1501 North West 9th Avenue Second Floor, Department Of Neurology D4-5 | Miami | Florida | United States | 33136 |
| 13 | University Of South Florida, Movement Disorders Center, 5 Tampa General Circle Suite 410 | Tampa | Florida | United States | 33606 |
| 14 | Emory University, Wesley Woods Health Center, 1841 Clifton Road NE Room 328 | Atlanta | Georgia | United States | 30329 |
| 15 | Medical College Of Georgia, Movement Disorders Clinic, 1429 Harper Street HF 1121 | Augusta | Georgia | United States | 30912 |
| 16 | Pacific Health Research Institute, 405 North Kuakini Street, Suite 1011, | Honolulu | Hawaii | United States | 96817 |
| 17 | Northwestern University, 710 North Lake Shore Drive | Chicago | Illinois | United States | 60611 |
| 18 | Rush University Medical Center, Department Of Neurological Sciences, 1725 West Harrison Suite 755, | Chicago | Illinois | United States | 60612 |
| 19 | Evanston Northwestern Healthcare, Department Of Neurology, 2100 Pfingsten Road Suite B110 | Glenview | Illinois | United States | 60026 |
| 20 | Southern Illinois University School Of Medicine, PO Box 19645 | Springfield | Illinois | United States | 62794-9645 |
| 21 | Indiana University School Of Medicine, Outpatient Clinical Research Facility, 535 Barnhill Drive Room #150 | Indianapolis | Indiana | United States | 46202 |
| 22 | University Of Kansas Medical Center, 3599 Rainbow Blvd, Department Of Neurology Mail Stop # 2012 | Kansas City | Kansas | United States | 66160-7314 |
| 23 | University Of Kentucky Clinical Research, C201 Kentucky Clinic, 740 South Limestone Street | Lexington | Kentucky | United States | 40536-0284 |
| 24 | Ochsner Clinic Foundation, 1514 Jefferson Highway, Dept. Of Neurology 7th Floor | New Orleans | Louisiana | United States | 70121 |
| 25 | LSU Health Science Center Shreveport, 1501 Kings Highway, Room 3-436 | Shreveport | Louisiana | United States | 71130 |
| 26 | University Of Maryland School Of Medicine, Department Of Neurology, 22 South Greene Street N4W46 | Baltimore | Maryland | United States | 21201 |
| 27 | Johns Hopkins University, 601 North Caroline Street, Suite 5064 | Baltimore | Maryland | United States | 21287-0875 |
| 28 | Brigham & Women's Hospital, Neurology Department ASB2, 75 Francis Street | Boston | Massachusetts | United States | 02115 |
| 29 | Beth Israel Deaconess Medical Center, 330 Brookline Avenue Shapiro 809D | Boston | Massachusetts | United States | 02215 |
| 30 | University Of Michigan, 1500 E Medical Center Drive, B1 H202 Nuclear Medicine, | Ann Arbor | Michigan | United States | 48109-0028 |
| 31 | Michigan State University, Department Of Neurology A217 Clinical Center, 138 Service Road | East Lansing | Michigan | United States | 48824 |
| 32 | Struthers Parkinson's Center, 6701 Country Club Drive, | Golden Valley | Minnesota | United States | 55427 |
| 33 | Washington University School Of Medicine, 660 South Euclid Avenue, Campus 8111, | St Louis | Missouri | United States | 63110 |
| 34 | Dartmouth Hitchcock Medical Center, One Medical Center Drive, 2 Buck Road | Lebanon | New Hampshire | United States | 03756 |
| 35 | UMDNJ Robert Wood Johnson Medical School, Dept Of Neurology Suite 6100, 125 Paterson Street | New Brunswick | New Jersey | United States | 08901 |
| 36 | SUNY Downstate Medical Center, 450 Clarkson Avenue, Department Of Neurology Box 1213 | Brooklyn | New York | United States | 11203-2098 |
| 37 | Northshore-LIJ Health System, The Feinstein Institute FPR Medical Research, 350 Community Drive Room, | Manhasset | New York | United States | 11030 |
| 38 | Duke University Medical Center, Duke Health Center At Morreene Road, 932 Morreene Road Room 213, | Durham | North Carolina | United States | 27705 |
| 39 | OHSU Oregon Health &Science University, Department Of Neurology, 3181 South West Sam Jackson Park Road | Portland | Oregon | United States | 97239 |
| 40 | Thomas Jefferson University, 1015 Chestnut Street Suite 520 | Philadelphia | Pennsylvania | United States | 19107 |
| 41 | University of Pennsylvania; Pennsylvania Hospital, Penn Neurological Institute, 330 South Ninth Street | Philadelphia | Pennsylvania | United States | 19107 |
| 42 | Thomas Jefferson University/Lankenau Hospital, Lankenau Medical Building Suite 161 East, 100 Lancaster Avenue | Wynnewood | Pennsylvania | United States | 19096 |
| 43 | Medical University Of South Carolina, Charleston Memorial Hospital, 326 Calhoun Street Suite 308 | Charleston | South Carolina | United States | 29401 |
| 44 | Vanderbilt University Medical Center, 2311 Pierce Avenue, Room 2217, | Nashville | Tennessee | United States | 37212 |
| 45 | University Of Texas Southwestern Med Ctr. At Dallas, 5323 Harry Hines Boulevard H1-108 | Dallas | Texas | United States | 75390-9016 |
| 46 | Baylor College Of Medicine, 6550 Fannin Suite 1801 | Houston | Texas | United States | 77030 |
| 47 | University Of Vermont, Department Of Neurology , Given Building C-219, 89 Beaumont Avenue | Burlington | Vermont | United States | 05405 |
| 48 | University Of Virginia Neurology Fontaine, Department Of Neurology, 500 Ray C Hunt Drive | Charlottesville | Virginia | United States | 22903 |
| 49 | University Of Calgary Movement Disorders Program, Dept Of Clin Neurosciences Area 3 Neurology, 3350 Hospital DR NW Health Sciences Centre | Calgary | Alberta | Canada | T2N4NI |
| 50 | University Of Alberta, 10230-111 Avenue Room 0601, Movement Disorders Clinic Glenrose Rehab Hospital | Edmonton | Alberta | Canada | T5G 0B7 |
Sponsors and Collaborators
- University of Rochester
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Karl Kieburtz, MD, Coordination Center
- Principal Investigator: Barbara Tilley, PhD, Statistics Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Karl Kieburtz,
Principal Investigator,
University of Rochester
ClinicalTrials.gov Identifier:
NCT00449865
Other Study ID Numbers:
- U01NS43128 NET-PD
- CRC
First Posted:
Mar 21, 2007
Last Update Posted:
Apr 2, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Karl Kieburtz,
Principal Investigator,
University of Rochester
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Creatine |
|---|---|---|
| Arm/Group Description | placebo: an inactive substance | creatine monohydrate (10 gram /day) |
| Period Title: Overall Study | ||
| STARTED | 867 | 874 |
| Completed Year 1 | 802 | 822 |
| Completed Year 2 | 768 | 766 |
| Completed Year 3 | 719 | 715 |
| Completed Year 4 | 521 | 523 |
| COMPLETED | 345 | 340 |
| NOT COMPLETED | 522 | 534 |
Baseline Characteristics
| Arm/Group Title | Placebo | Creatine | Total |
|---|---|---|---|
| Arm/Group Description | placebo: an inactive substance | creatine 5 grams twice daily | Total of all reporting groups |
| Overall Participants | 867 | 874 | 1741 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
61.5
(9.6)
|
62.1
(9.7)
|
61.8
(9.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
313
36.1%
|
305
34.9%
|
618
35.5%
|
| Male |
554
63.9%
|
569
65.1%
|
1123
64.5%
|
| Time since diagnosis, y (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
1.6
(1.1)
|
1.5
(1.1)
|
1.5
(1.1)
|
| Total Unified Parkinson's Disease Rating Scale (UPDRS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
25.9
(11)
|
26.5
(11.7)
|
26.2
(11.4)
|
Outcome Measures
| Title | The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years. |
|---|---|
| Description | All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST). |
| Time Frame | Change from baseline to 5 YEARS |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis). |
| Arm/Group Title | Placebo | Creatine |
|---|---|---|
| Arm/Group Description | placebo: an inactive substance | creatine monohydrate (10 grams/day) |
| Measure Participants | 478 | 477 |
| Mean (95% Confidence Interval) [summed-ranks] |
2360
|
2414
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Creatine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.45 |
| Comments | ||
| Method | Global Statistical Test | |
| Comments | The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8). | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo | Creatine | ||
| Arm/Group Description | placebo: an inactive substance | creatine 5 grams twice daily | ||
All Cause Mortality |
||||
| Placebo | Creatine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo | Creatine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 347/867 (40%) | 315/874 (36%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/867 (0%) | 1/874 (0.1%) | ||
| Haemolytic anaemia | 1/867 (0.1%) | 0/874 (0%) | ||
| Cardiac disorders | ||||
| Angina pectoris | 1/867 (0.1%) | 2/874 (0.2%) | ||
| Angina unstable | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Aortic valve disease | 1/867 (0.1%) | 0/874 (0%) | ||
| Aortic valve incompetence | 1/867 (0.1%) | 0/874 (0%) | ||
| Atrial fibrillation | 4/867 (0.5%) | 9/874 (1%) | ||
| Bradycardia | 4/867 (0.5%) | 0/874 (0%) | ||
| Brugada syndrome | 0/867 (0%) | 1/874 (0.1%) | ||
| Cardiac arrest | 4/867 (0.5%) | 7/874 (0.8%) | ||
| Cardiac disorder | 1/867 (0.1%) | 0/874 (0%) | ||
| Cardiac failure | 1/867 (0.1%) | 0/874 (0%) | ||
| Cardiac failure congestive | 1/867 (0.1%) | 3/874 (0.3%) | ||
| Cardio-respiratory arrest | 1/867 (0.1%) | 3/874 (0.3%) | ||
| Cardiopulmonary failure | 1/867 (0.1%) | 0/874 (0%) | ||
| Coronary artery disease | 3/867 (0.3%) | 4/874 (0.5%) | ||
| Coronary artery occlusion | 1/867 (0.1%) | 0/874 (0%) | ||
| Coronary artery stenosis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Diastolic dysfunction | 1/867 (0.1%) | 0/874 (0%) | ||
| Hypertensive heart disease | 1/867 (0.1%) | 0/874 (0%) | ||
| Mitral valve stenosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Myocardial infarction | 8/867 (0.9%) | 12/874 (1.4%) | ||
| Myocardial ischaemia | 0/867 (0%) | 2/874 (0.2%) | ||
| Palpitations | 1/867 (0.1%) | 0/874 (0%) | ||
| Sick sinus syndrome | 0/867 (0%) | 1/874 (0.1%) | ||
| Ventricular fibrillation | 1/867 (0.1%) | 0/874 (0%) | ||
| Ventricular tachycardia | 0/867 (0%) | 1/874 (0.1%) | ||
| Congenital, familial and genetic disorders | ||||
| Congenital coronary artery malformation | 1/867 (0.1%) | 0/874 (0%) | ||
| Factor V deficiency | 0/867 (0%) | 1/874 (0.1%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 4/867 (0.5%) | 1/874 (0.1%) | ||
| Vertigo positional | 0/867 (0%) | 1/874 (0.1%) | ||
| Endocrine disorders | ||||
| Goitre | 2/867 (0.2%) | 0/874 (0%) | ||
| Hyperparathyroidism | 1/867 (0.1%) | 0/874 (0%) | ||
| Eye disorders | ||||
| Amaurosis fugax | 0/867 (0%) | 1/874 (0.1%) | ||
| Blindness transient | 0/867 (0%) | 1/874 (0.1%) | ||
| Macular oedema | 1/867 (0.1%) | 0/874 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal adhesions | 1/867 (0.1%) | 0/874 (0%) | ||
| Abdominal hernia | 0/867 (0%) | 2/874 (0.2%) | ||
| Abdominal pain | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Abdominal pain upper | 1/867 (0.1%) | 0/874 (0%) | ||
| Anal fissure | 0/867 (0%) | 1/874 (0.1%) | ||
| Ascites | 0/867 (0%) | 1/874 (0.1%) | ||
| Colitis | 0/867 (0%) | 1/874 (0.1%) | ||
| Colitis ischaemic | 0/867 (0%) | 3/874 (0.3%) | ||
| Constipation | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Diarrhoea | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Dyspepsia | 1/867 (0.1%) | 0/874 (0%) | ||
| Dysphagia | 1/867 (0.1%) | 0/874 (0%) | ||
| Faecaloma | 1/867 (0.1%) | 0/874 (0%) | ||
| Gastrointestinal haemorrhage | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Hiatus hernia | 0/867 (0%) | 1/874 (0.1%) | ||
| Ileus | 1/867 (0.1%) | 2/874 (0.2%) | ||
| Impaired gastric emptying | 0/867 (0%) | 1/874 (0.1%) | ||
| Inguinal hernia | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Intestinal obstruction | 3/867 (0.3%) | 6/874 (0.7%) | ||
| Nausea | 2/867 (0.2%) | 0/874 (0%) | ||
| Oesophageal achalasia | 0/867 (0%) | 2/874 (0.2%) | ||
| Oesophageal stenosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Oesophageal ulcer haemorrhage | 0/867 (0%) | 1/874 (0.1%) | ||
| Pharyngoesophageal diverticulum | 0/867 (0%) | 1/874 (0.1%) | ||
| Rectal haemorrhage | 0/867 (0%) | 1/874 (0.1%) | ||
| Small intestinal obstruction | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Upper gastrointestinal haemorrhage | 1/867 (0.1%) | 2/874 (0.2%) | ||
| Vomiting | 3/867 (0.3%) | 0/874 (0%) | ||
| General disorders | ||||
| Adverse drug reaction | 0/867 (0%) | 1/874 (0.1%) | ||
| Asthenia | 5/867 (0.6%) | 2/874 (0.2%) | ||
| Chest discomfort | 2/867 (0.2%) | 0/874 (0%) | ||
| Chest pain | 15/867 (1.7%) | 14/874 (1.6%) | ||
| Cyst | 0/867 (0%) | 2/874 (0.2%) | ||
| Death | 2/867 (0.2%) | 5/874 (0.6%) | ||
| Drug interaction | 1/867 (0.1%) | 0/874 (0%) | ||
| Facial pain | 0/867 (0%) | 1/874 (0.1%) | ||
| Fatigue | 0/867 (0%) | 1/874 (0.1%) | ||
| Gait disturbance | 1/867 (0.1%) | 0/874 (0%) | ||
| Medical device complication | 1/867 (0.1%) | 0/874 (0%) | ||
| Non-cardiac chest pain | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Pain | 9/867 (1%) | 4/874 (0.5%) | ||
| Ulcer | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Hepatobiliary disorders | ||||
| Bile duct stone | 0/867 (0%) | 1/874 (0.1%) | ||
| Cholangitis | 0/867 (0%) | 1/874 (0.1%) | ||
| Cholecystitis | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Cholelithiasis | 0/867 (0%) | 3/874 (0.3%) | ||
| Gallbladder disorder | 1/867 (0.1%) | 0/874 (0%) | ||
| Immune system disorders | ||||
| Drug hypersensitivity | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Infections and infestations | ||||
| Abscess | 0/867 (0%) | 1/874 (0.1%) | ||
| Appendicitis | 4/867 (0.5%) | 1/874 (0.1%) | ||
| Appendicitis perforated | 0/867 (0%) | 1/874 (0.1%) | ||
| Bacterial infection | 1/867 (0.1%) | 0/874 (0%) | ||
| Bronchitis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Cellulitis | 4/867 (0.5%) | 4/874 (0.5%) | ||
| Clostridial infection | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Clostridium difficile colitis | 0/867 (0%) | 1/874 (0.1%) | ||
| Coccidioidomycosis | 1/867 (0.1%) | 0/874 (0%) | ||
| Creutzfeldt-Jakob disease | 1/867 (0.1%) | 0/874 (0%) | ||
| Cystitis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Cytomegalovirus infection | 0/867 (0%) | 1/874 (0.1%) | ||
| Diverticulitis | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Gastroenteritis | 2/867 (0.2%) | 0/874 (0%) | ||
| Groin abscess | 0/867 (0%) | 1/874 (0.1%) | ||
| Herpes zoster | 1/867 (0.1%) | 0/874 (0%) | ||
| Hip infection | 1/867 (0.1%) | 0/874 (0%) | ||
| Infection | 1/867 (0.1%) | 4/874 (0.5%) | ||
| Influenza | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Intervertebral discitis | 1/867 (0.1%) | 0/874 (0%) | ||
| Kidney infection | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Labyrinthitis | 1/867 (0.1%) | 0/874 (0%) | ||
| Liver abscess | 1/867 (0.1%) | 0/874 (0%) | ||
| Lung infection | 0/867 (0%) | 1/874 (0.1%) | ||
| Meningitis bacterial | 1/867 (0.1%) | 0/874 (0%) | ||
| Meningitis viral | 1/867 (0.1%) | 0/874 (0%) | ||
| Oesophageal infection | 1/867 (0.1%) | 0/874 (0%) | ||
| Osteomyelitis | 1/867 (0.1%) | 0/874 (0%) | ||
| Peridiverticulitis | 0/867 (0%) | 1/874 (0.1%) | ||
| Pharyngitis | 1/867 (0.1%) | 0/874 (0%) | ||
| Pneumonia | 18/867 (2.1%) | 16/874 (1.8%) | ||
| Pyelonephritis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Sepsis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Septic shock | 1/867 (0.1%) | 0/874 (0%) | ||
| Sinusitis | 1/867 (0.1%) | 0/874 (0%) | ||
| Staphylococcal infection | 2/867 (0.2%) | 0/874 (0%) | ||
| Urinary tract infection | 9/867 (1%) | 5/874 (0.6%) | ||
| Urosepsis | 4/867 (0.5%) | 0/874 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Accidental overdose | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Arterial injury | 0/867 (0%) | 1/874 (0.1%) | ||
| Avulsion fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Cervical vertebral fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Clavicle fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Concussion | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Contusion | 2/867 (0.2%) | 0/874 (0%) | ||
| Fall | 11/867 (1.3%) | 7/874 (0.8%) | ||
| Femoral neck fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Femur fracture | 5/867 (0.6%) | 3/874 (0.3%) | ||
| Fibula fracture | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Forearm fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Foreign body | 1/867 (0.1%) | 0/874 (0%) | ||
| Fracture | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Hand fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Heat exhaustion | 0/867 (0%) | 1/874 (0.1%) | ||
| Hip fracture | 12/867 (1.4%) | 10/874 (1.1%) | ||
| Humerus fracture | 2/867 (0.2%) | 0/874 (0%) | ||
| Injury | 1/867 (0.1%) | 0/874 (0%) | ||
| Joint sprain | 0/867 (0%) | 1/874 (0.1%) | ||
| Laceration | 4/867 (0.5%) | 1/874 (0.1%) | ||
| Ligament rupture | 0/867 (0%) | 1/874 (0.1%) | ||
| Limb crushing injury | 1/867 (0.1%) | 0/874 (0%) | ||
| Limb injury | 1/867 (0.1%) | 0/874 (0%) | ||
| Lower limb fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Lumbar vertebral fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Meniscus lesion | 0/867 (0%) | 1/874 (0.1%) | ||
| Overdose | 0/867 (0%) | 1/874 (0.1%) | ||
| Pelvic fracture | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Periorbital haematoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Rib fracture | 4/867 (0.5%) | 2/874 (0.2%) | ||
| Road traffic accident | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Spinal compression fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Sternal fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Stress fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Subdural haematoma | 3/867 (0.3%) | 2/874 (0.2%) | ||
| Subdural haemorrhage | 1/867 (0.1%) | 0/874 (0%) | ||
| Tendon injury | 2/867 (0.2%) | 0/874 (0%) | ||
| Tendon rupture | 0/867 (0%) | 1/874 (0.1%) | ||
| Thoracic vertebral fracture | 0/867 (0%) | 1/874 (0.1%) | ||
| Tibia fracture | 1/867 (0.1%) | 3/874 (0.3%) | ||
| Ulna fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Upper limb fracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Investigations | ||||
| Blood sodium decreased | 0/867 (0%) | 1/874 (0.1%) | ||
| Catheterisation cardiac | 1/867 (0.1%) | 0/874 (0%) | ||
| Heart rate irregular | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Hepatic enzyme increased | 1/867 (0.1%) | 0/874 (0%) | ||
| Investigation | 0/867 (0%) | 1/874 (0.1%) | ||
| Medical observation | 0/867 (0%) | 1/874 (0.1%) | ||
| Prostatic specific antigen increased | 0/867 (0%) | 1/874 (0.1%) | ||
| Weight decreased | 2/867 (0.2%) | 0/874 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Diabetes mellitus | 1/867 (0.1%) | 0/874 (0%) | ||
| Failure to thrive | 0/867 (0%) | 1/874 (0.1%) | ||
| Hypercalcaemia | 0/867 (0%) | 1/874 (0.1%) | ||
| Hypokalaemia | 2/867 (0.2%) | 0/874 (0%) | ||
| Hyponatraemia | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 7/867 (0.8%) | 3/874 (0.3%) | ||
| Arthritis | 6/867 (0.7%) | 13/874 (1.5%) | ||
| Back pain | 1/867 (0.1%) | 3/874 (0.3%) | ||
| Cervical spinal stenosis | 1/867 (0.1%) | 0/874 (0%) | ||
| Exostosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Fall | 1/867 (0.1%) | 0/874 (0%) | ||
| Intervertebral disc degeneration | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Intervertebral disc protrusion | 9/867 (1%) | 0/874 (0%) | ||
| Joint instability | 1/867 (0.1%) | 0/874 (0%) | ||
| Lumbar spinal stenosis | 3/867 (0.3%) | 11/874 (1.3%) | ||
| Muscle contracture | 1/867 (0.1%) | 0/874 (0%) | ||
| Musculoskeletal pain | 1/867 (0.1%) | 2/874 (0.2%) | ||
| Musculoskeletal stiffness | 1/867 (0.1%) | 0/874 (0%) | ||
| Osteoarthritis | 16/867 (1.8%) | 15/874 (1.7%) | ||
| Rhabdomyolysis | 2/867 (0.2%) | 0/874 (0%) | ||
| Rotator cuff syndrome | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Scoliosis | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Spinal column stenosis | 11/867 (1.3%) | 4/874 (0.5%) | ||
| Spinal disorder | 1/867 (0.1%) | 0/874 (0%) | ||
| Spinal osteoarthritis | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Spondylolisthesis | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Tendonitis | 1/867 (0.1%) | 0/874 (0%) | ||
| Vertebral foraminal stenosis | 1/867 (0.1%) | 0/874 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Benign neoplasm | 0/867 (0%) | 1/874 (0.1%) | ||
| Bile duct cancer | 0/867 (0%) | 1/874 (0.1%) | ||
| Bladder cancer | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Bladder cancer recurrent | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Bladder transitional cell carcinoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Brain neoplasm | 0/867 (0%) | 1/874 (0.1%) | ||
| Breast cancer | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Breast cancer metastatic | 1/867 (0.1%) | 0/874 (0%) | ||
| Carcinoid tumour of the pancreas | 0/867 (0%) | 1/874 (0.1%) | ||
| Cervix carcinoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Chordoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Colon cancer | 3/867 (0.3%) | 1/874 (0.1%) | ||
| Colorectal cancer | 0/867 (0%) | 1/874 (0.1%) | ||
| Endometrial cancer | 1/867 (0.1%) | 0/874 (0%) | ||
| Gastrointestinal stromal tumour | 1/867 (0.1%) | 0/874 (0%) | ||
| Glioblastoma multiforme | 1/867 (0.1%) | 0/874 (0%) | ||
| Hepatic neoplasm | 0/867 (0%) | 1/874 (0.1%) | ||
| Hepatic neoplasm malignant | 1/867 (0.1%) | 0/874 (0%) | ||
| Large cell carcinoma of the respiratory tract stage unspecified | 1/867 (0.1%) | 0/874 (0%) | ||
| Leukaemia plasmacytic | 1/867 (0.1%) | 0/874 (0%) | ||
| Lung cancer metastatic | 2/867 (0.2%) | 0/874 (0%) | ||
| Lung neoplasm | 1/867 (0.1%) | 0/874 (0%) | ||
| Lung neoplasm malignant | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Malignant melanoma | 3/867 (0.3%) | 0/874 (0%) | ||
| Mantle cell lymphoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Metastases to meninges | 0/867 (0%) | 1/874 (0.1%) | ||
| Metastasis | 0/867 (0%) | 1/874 (0.1%) | ||
| Metastatic neoplasm | 1/867 (0.1%) | 0/874 (0%) | ||
| Multiple myeloma | 1/867 (0.1%) | 0/874 (0%) | ||
| Non-Hodgkin's lymphoma stage IV | 1/867 (0.1%) | 0/874 (0%) | ||
| Ovarian cancer | 0/867 (0%) | 2/874 (0.2%) | ||
| Pancreatic carcinoma | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Prostate cancer | 3/867 (0.3%) | 2/874 (0.2%) | ||
| Rectal cancer | 1/867 (0.1%) | 0/874 (0%) | ||
| Rectosigmoid cancer | 0/867 (0%) | 1/874 (0.1%) | ||
| Renal cell carcinoma | 3/867 (0.3%) | 0/874 (0%) | ||
| Small cell lung cancer stage unspecified | 1/867 (0.1%) | 0/874 (0%) | ||
| Squamous cell carcinoma | 2/867 (0.2%) | 0/874 (0%) | ||
| T-cell lymphoma | 1/867 (0.1%) | 0/874 (0%) | ||
| Thyroid cancer | 0/867 (0%) | 1/874 (0.1%) | ||
| Nervous system disorders | ||||
| Amyotrophic lateral sclerosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Carotid artery occlusion | 0/867 (0%) | 2/874 (0.2%) | ||
| Carotid artery stenosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Cerebellar haemorrhage | 0/867 (0%) | 1/874 (0.1%) | ||
| Cerebral haemorrhage | 1/867 (0.1%) | 0/874 (0%) | ||
| Cerebral infarction | 3/867 (0.3%) | 0/874 (0%) | ||
| Cerebrovascular accident | 6/867 (0.7%) | 6/874 (0.7%) | ||
| Cognitive disorder | 1/867 (0.1%) | 0/874 (0%) | ||
| Convulsion | 0/867 (0%) | 1/874 (0.1%) | ||
| Dementia | 1/867 (0.1%) | 0/874 (0%) | ||
| Dementia Alzheimer's type | 1/867 (0.1%) | 0/874 (0%) | ||
| Dizziness | 5/867 (0.6%) | 1/874 (0.1%) | ||
| Dysarthria | 0/867 (0%) | 1/874 (0.1%) | ||
| Encephalopathy | 0/867 (0%) | 1/874 (0.1%) | ||
| Epilepsy | 1/867 (0.1%) | 0/874 (0%) | ||
| Facial palsy | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Grand mal convulsion | 0/867 (0%) | 1/874 (0.1%) | ||
| Guillain-Barre syndrome | 0/867 (0%) | 1/874 (0.1%) | ||
| Haemorrhagic stroke | 2/867 (0.2%) | 0/874 (0%) | ||
| Headache | 1/867 (0.1%) | 0/874 (0%) | ||
| Hypoaesthesia | 1/867 (0.1%) | 0/874 (0%) | ||
| Intracranial hypotension | 1/867 (0.1%) | 0/874 (0%) | ||
| Ischaemic stroke | 2/867 (0.2%) | 0/874 (0%) | ||
| Lethargy | 0/867 (0%) | 1/874 (0.1%) | ||
| Loss of consciousness | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Migraine | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Migraine with aura | 0/867 (0%) | 1/874 (0.1%) | ||
| Motor dysfunction | 0/867 (0%) | 1/874 (0.1%) | ||
| Multiple sclerosis relapse | 1/867 (0.1%) | 0/874 (0%) | ||
| Nerve compression | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Neuropathy peripheral | 1/867 (0.1%) | 0/874 (0%) | ||
| Parkinson's disease | 4/867 (0.5%) | 4/874 (0.5%) | ||
| Presyncope | 3/867 (0.3%) | 2/874 (0.2%) | ||
| Sciatica | 1/867 (0.1%) | 0/874 (0%) | ||
| Spinal cord compression | 1/867 (0.1%) | 0/874 (0%) | ||
| Spinal cord disorder | 1/867 (0.1%) | 0/874 (0%) | ||
| Subarachnoid haemorrhage | 2/867 (0.2%) | 0/874 (0%) | ||
| Syncope | 15/867 (1.7%) | 12/874 (1.4%) | ||
| Transient ischaemic attack | 6/867 (0.7%) | 4/874 (0.5%) | ||
| Tremor | 2/867 (0.2%) | 0/874 (0%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 1/867 (0.1%) | 0/874 (0%) | ||
| Psychiatric disorders | ||||
| Aggression | 1/867 (0.1%) | 0/874 (0%) | ||
| Anxiety | 3/867 (0.3%) | 1/874 (0.1%) | ||
| Confusional state | 3/867 (0.3%) | 2/874 (0.2%) | ||
| Delusion | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Depression | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Disorientation | 0/867 (0%) | 1/874 (0.1%) | ||
| Food aversion | 1/867 (0.1%) | 0/874 (0%) | ||
| Hallucination | 3/867 (0.3%) | 3/874 (0.3%) | ||
| Hallucination, visual | 1/867 (0.1%) | 0/874 (0%) | ||
| Intentional self-injury | 1/867 (0.1%) | 0/874 (0%) | ||
| Major depression | 0/867 (0%) | 1/874 (0.1%) | ||
| Mania | 1/867 (0.1%) | 0/874 (0%) | ||
| Mental disorder | 2/867 (0.2%) | 1/874 (0.1%) | ||
| Mental status changes | 1/867 (0.1%) | 0/874 (0%) | ||
| Panic attack | 0/867 (0%) | 1/874 (0.1%) | ||
| Paranoia | 1/867 (0.1%) | 0/874 (0%) | ||
| Psychotic disorder | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Suicidal ideation | 0/867 (0%) | 2/874 (0.2%) | ||
| Renal and urinary disorders | ||||
| Bladder disorder | 0/867 (0%) | 1/874 (0.1%) | ||
| Bladder prolapse | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Contracted bladder | 0/867 (0%) | 1/874 (0.1%) | ||
| Nephrolithiasis | 6/867 (0.7%) | 2/874 (0.2%) | ||
| Renal colic | 2/867 (0.2%) | 0/874 (0%) | ||
| Renal failure | 1/867 (0.1%) | 0/874 (0%) | ||
| Renal failure acute | 1/867 (0.1%) | 0/874 (0%) | ||
| Ureteric stenosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Urinary incontinence | 0/867 (0%) | 1/874 (0.1%) | ||
| Urinary retention | 4/867 (0.5%) | 1/874 (0.1%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Cystocele | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Epididymitis | 0/867 (0%) | 1/874 (0.1%) | ||
| Joint dislocation | 0/867 (0%) | 1/874 (0.1%) | ||
| Ovarian cyst | 1/867 (0.1%) | 0/874 (0%) | ||
| Prostatitis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Prostatomegaly | 4/867 (0.5%) | 0/874 (0%) | ||
| Rectocele | 1/867 (0.1%) | 0/874 (0%) | ||
| Uterine polyp | 0/867 (0%) | 1/874 (0.1%) | ||
| Uterine prolapse | 1/867 (0.1%) | 0/874 (0%) | ||
| Vaginal prolapse | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 0/867 (0%) | 1/874 (0.1%) | ||
| Atelectasis | 1/867 (0.1%) | 0/874 (0%) | ||
| Chest Pain | 0/867 (0%) | 1/874 (0.1%) | ||
| Chronic obstructive pulmonary disease | 1/867 (0.1%) | 0/874 (0%) | ||
| Cough | 1/867 (0.1%) | 0/874 (0%) | ||
| Dyspnoea | 6/867 (0.7%) | 2/874 (0.2%) | ||
| Laryngospasm | 1/867 (0.1%) | 0/874 (0%) | ||
| Pleural effusion | 0/867 (0%) | 2/874 (0.2%) | ||
| Pneumonia aspiration | 4/867 (0.5%) | 2/874 (0.2%) | ||
| Pneumothorax | 2/867 (0.2%) | 0/874 (0%) | ||
| Pulmonary embolism | 11/867 (1.3%) | 7/874 (0.8%) | ||
| Pulmonary interstitial emphysema syndrome | 0/867 (0%) | 1/874 (0.1%) | ||
| Respiratory arrest | 1/867 (0.1%) | 0/874 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Angioedema | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Surgical and medical procedures | ||||
| Angioplasty | 1/867 (0.1%) | 0/874 (0%) | ||
| Aortic valve replacement | 3/867 (0.3%) | 0/874 (0%) | ||
| Appendicectomy | 0/867 (0%) | 1/874 (0.1%) | ||
| Benign tumour excision | 1/867 (0.1%) | 0/874 (0%) | ||
| Cardiac pacemaker insertion | 0/867 (0%) | 2/874 (0.2%) | ||
| Cholecystectomy | 0/867 (0%) | 3/874 (0.3%) | ||
| Colporrhaphy | 0/867 (0%) | 1/874 (0.1%) | ||
| Deep brain stimulation | 27/867 (3.1%) | 24/874 (2.7%) | ||
| Heart valve replacement | 1/867 (0.1%) | 0/874 (0%) | ||
| Hernia hiatus repair | 0/867 (0%) | 1/874 (0.1%) | ||
| Hernia repair | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Hip arthroplasty | 5/867 (0.6%) | 2/874 (0.2%) | ||
| Hysterectomy | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Joint arthroplasty | 1/867 (0.1%) | 5/874 (0.6%) | ||
| Knee arthroplasty | 5/867 (0.6%) | 3/874 (0.3%) | ||
| Large intestine anastomosis | 0/867 (0%) | 1/874 (0.1%) | ||
| Meniscus operation | 0/867 (0%) | 1/874 (0.1%) | ||
| Mitral valve replacement | 1/867 (0.1%) | 0/874 (0%) | ||
| Nephrectomy | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Prophylaxis of nausea and vomiting | 0/867 (0%) | 1/874 (0.1%) | ||
| Prostatectomy | 0/867 (0%) | 1/874 (0.1%) | ||
| Shoulder arthroplasty | 0/867 (0%) | 1/874 (0.1%) | ||
| Spinal decompression | 1/867 (0.1%) | 0/874 (0%) | ||
| Spinal fusion surgery | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Spinal laminectomy | 1/867 (0.1%) | 3/874 (0.3%) | ||
| Stent placement | 2/867 (0.2%) | 2/874 (0.2%) | ||
| Surgery | 1/867 (0.1%) | 2/874 (0.2%) | ||
| Thalamotomy | 1/867 (0.1%) | 0/874 (0%) | ||
| Thyroidectomy | 1/867 (0.1%) | 0/874 (0%) | ||
| Tracheostomy | 1/867 (0.1%) | 0/874 (0%) | ||
| Transurethral prostatectomy | 1/867 (0.1%) | 2/874 (0.2%) | ||
| Vascular disorders | ||||
| Aneurysm | 1/867 (0.1%) | 0/874 (0%) | ||
| Aortic aneurysm | 3/867 (0.3%) | 1/874 (0.1%) | ||
| Aortic dissection | 1/867 (0.1%) | 0/874 (0%) | ||
| Aortic occlusion | 0/867 (0%) | 1/874 (0.1%) | ||
| Aortic stenosis | 1/867 (0.1%) | 0/874 (0%) | ||
| Arterial stenosis | 1/867 (0.1%) | 0/874 (0%) | ||
| Deep vein thrombosis | 0/867 (0%) | 6/874 (0.7%) | ||
| Embolism | 0/867 (0%) | 1/874 (0.1%) | ||
| Fibromuscular dysplasia | 0/867 (0%) | 1/874 (0.1%) | ||
| Hypertension | 4/867 (0.5%) | 0/874 (0%) | ||
| Hypertensive crisis | 1/867 (0.1%) | 0/874 (0%) | ||
| Hypotension | 3/867 (0.3%) | 2/874 (0.2%) | ||
| Orthostatic hypotension | 2/867 (0.2%) | 3/874 (0.3%) | ||
| Thrombosis | 1/867 (0.1%) | 1/874 (0.1%) | ||
| Venous thrombosis | 0/867 (0%) | 1/874 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Creatine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 687/867 (79.2%) | 698/874 (79.9%) | ||
| Eye disorders | ||||
| Cataract | 51/867 (5.9%) | 44/874 (5%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 107/867 (12.3%) | 121/874 (13.8%) | ||
| Diarrhoea | 50/867 (5.8%) | 65/874 (7.4%) | ||
| Gastrooesophageal reflux disease | 53/867 (6.1%) | 39/874 (4.5%) | ||
| Nausea | 101/867 (11.6%) | 99/874 (11.3%) | ||
| Pain | 122/867 (14.1%) | 121/874 (13.8%) | ||
| General disorders | ||||
| Fatigue | 47/867 (5.4%) | 48/874 (5.5%) | ||
| Oedema | 139/867 (16%) | 154/874 (17.6%) | ||
| Infections and infestations | ||||
| Sinusitis | 46/867 (5.3%) | 55/874 (6.3%) | ||
| Upper respiratory tract infection | 63/867 (7.3%) | 66/874 (7.6%) | ||
| Urinary tract infection | 109/867 (12.6%) | 85/874 (9.7%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 97/867 (11.2%) | 91/874 (10.4%) | ||
| Investigations | ||||
| Weight decreased | 50/867 (5.8%) | 35/874 (4%) | ||
| Weight increased | 101/867 (11.6%) | 137/874 (15.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 64/867 (7.4%) | 81/874 (9.3%) | ||
| Back pain | 106/867 (12.2%) | 105/874 (12%) | ||
| Muscle spasms | 53/867 (6.1%) | 101/874 (11.6%) | ||
| Musculoskeletal pain | 45/867 (5.2%) | 43/874 (4.9%) | ||
| Pain in extremity | 31/867 (3.6%) | 47/874 (5.4%) | ||
| Nervous system disorders | ||||
| Dizziness | 81/867 (9.3%) | 62/874 (7.1%) | ||
| Somnolence | 67/867 (7.7%) | 61/874 (7%) | ||
| Psychiatric disorders | ||||
| Anxiety | 77/867 (8.9%) | 65/874 (7.4%) | ||
| Depression | 106/867 (12.2%) | 100/874 (11.4%) | ||
| Hallucination | 39/867 (4.5%) | 45/874 (5.1%) | ||
| Insomnia | 101/867 (11.6%) | 96/874 (11%) | ||
| Renal and urinary disorders | ||||
| Pollakiuria | 50/867 (5.8%) | 34/874 (3.9%) | ||
| Proteinuria | 49/867 (5.7%) | 47/874 (5.4%) | ||
| Vascular disorders | ||||
| Hypertension | 46/867 (5.3%) | 46/874 (5.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Karl Kieburtz, Director of CTSI |
|---|---|
| Organization | University of Rochester |
| Phone | 585-275-0553 |
| Karl.kieburtz@chet.rochester.edu |
Responsible Party:
Karl Kieburtz,
Principal Investigator,
University of Rochester
ClinicalTrials.gov Identifier:
NCT00449865
Other Study ID Numbers:
- U01NS43128 NET-PD
- CRC
First Posted:
Mar 21, 2007
Last Update Posted:
Apr 2, 2015
Last Verified:
Mar 1, 2015