Trial Outcomes & Findings for NET-PD LS-1 Creatine in Parkinson's Disease (NCT NCT00449865)
NCT ID: NCT00449865
Last Updated: 2015-04-02
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1741 participants
Primary outcome timeframe
Change from baseline to 5 YEARS
Results posted on
2015-04-02
Participant Flow
Participant milestones
| Measure |
Placebo
placebo: an inactive substance
|
Creatine
creatine monohydrate (10 gram /day)
|
|---|---|---|
|
Overall Study
STARTED
|
867
|
874
|
|
Overall Study
Completed Year 1
|
802
|
822
|
|
Overall Study
Completed Year 2
|
768
|
766
|
|
Overall Study
Completed Year 3
|
719
|
715
|
|
Overall Study
Completed Year 4
|
521
|
523
|
|
Overall Study
COMPLETED
|
345
|
340
|
|
Overall Study
NOT COMPLETED
|
522
|
534
|
Reasons for withdrawal
| Measure |
Placebo
placebo: an inactive substance
|
Creatine
creatine monohydrate (10 gram /day)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
110
|
110
|
|
Overall Study
Lost to Follow-up
|
36
|
37
|
|
Overall Study
Physician Decision
|
13
|
12
|
|
Overall Study
Death
|
31
|
40
|
|
Overall Study
Protocol Violation
|
8
|
7
|
|
Overall Study
Study was stopped
|
324
|
328
|
Baseline Characteristics
NET-PD LS-1 Creatine in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=867 Participants
placebo: an inactive substance
|
Creatine
n=874 Participants
creatine 5 grams twice daily
|
Total
n=1741 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
313 Participants
n=5 Participants
|
305 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
554 Participants
n=5 Participants
|
569 Participants
n=7 Participants
|
1123 Participants
n=5 Participants
|
|
Time since diagnosis, y
|
1.6 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.5 years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
1.5 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Total Unified Parkinson's Disease Rating Scale (UPDRS)
|
25.9 units on a scale
STANDARD_DEVIATION 11 • n=5 Participants
|
26.5 units on a scale
STANDARD_DEVIATION 11.7 • n=7 Participants
|
26.2 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 5 YEARSPopulation: Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).
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).
Outcome measures
| Measure |
Placebo
n=478 Participants
placebo: an inactive substance
|
Creatine
n=477 Participants
creatine monohydrate (10 grams/day)
|
|---|---|---|
|
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.
|
2360 summed-ranks
Interval 2249.0 to 2470.0
|
2414 summed-ranks
Interval 2304.0 to 2524.0
|
Adverse Events
Placebo
Serious events: 347 serious events
Other events: 687 other events
Deaths: 0 deaths
Creatine
Serious events: 315 serious events
Other events: 698 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=867 participants at risk
placebo: an inactive substance
|
Creatine
n=874 participants at risk
creatine 5 grams twice daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/867
|
0.11%
1/874
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Angina pectoris
|
0.12%
1/867
|
0.23%
2/874
|
|
Cardiac disorders
Angina unstable
|
0.12%
1/867
|
0.11%
1/874
|
|
Cardiac disorders
Aortic valve disease
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Aortic valve incompetence
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
4/867
|
1.0%
9/874
|
|
Cardiac disorders
Bradycardia
|
0.46%
4/867
|
0.00%
0/874
|
|
Cardiac disorders
Brugada syndrome
|
0.00%
0/867
|
0.11%
1/874
|
|
Cardiac disorders
Cardiac arrest
|
0.46%
4/867
|
0.80%
7/874
|
|
Cardiac disorders
Cardiac disorder
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Cardiac failure
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Cardiac failure congestive
|
0.12%
1/867
|
0.34%
3/874
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
1/867
|
0.34%
3/874
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Coronary artery disease
|
0.35%
3/867
|
0.46%
4/874
|
|
Cardiac disorders
Coronary artery occlusion
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Coronary artery stenosis
|
0.12%
1/867
|
0.11%
1/874
|
|
Cardiac disorders
Diastolic dysfunction
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Hypertensive heart disease
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
8/867
|
1.4%
12/874
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/867
|
0.23%
2/874
|
|
Cardiac disorders
Palpitations
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/867
|
0.11%
1/874
|
|
Cardiac disorders
Ventricular fibrillation
|
0.12%
1/867
|
0.00%
0/874
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/867
|
0.11%
1/874
|
|
Congenital, familial and genetic disorders
Congenital coronary artery malformation
|
0.12%
1/867
|
0.00%
0/874
|
|
Congenital, familial and genetic disorders
Factor V deficiency
|
0.00%
0/867
|
0.11%
1/874
|
|
Ear and labyrinth disorders
Vertigo
|
0.46%
4/867
|
0.11%
1/874
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/867
|
0.11%
1/874
|
|
Endocrine disorders
Goitre
|
0.23%
2/867
|
0.00%
0/874
|
|
Endocrine disorders
Hyperparathyroidism
|
0.12%
1/867
|
0.00%
0/874
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/867
|
0.11%
1/874
|
|
Eye disorders
Blindness transient
|
0.00%
0/867
|
0.11%
1/874
|
|
Eye disorders
Macular oedema
|
0.12%
1/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.12%
1/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/867
|
0.23%
2/874
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
2/867
|
0.23%
2/874
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
1/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/867
|
0.34%
3/874
|
|
Gastrointestinal disorders
Constipation
|
0.12%
1/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
2/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Dyspepsia
|
0.12%
1/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Dysphagia
|
0.12%
1/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Faecaloma
|
0.12%
1/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
2/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Ileus
|
0.12%
1/867
|
0.23%
2/874
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
1/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.35%
3/867
|
0.69%
6/874
|
|
Gastrointestinal disorders
Nausea
|
0.23%
2/867
|
0.00%
0/874
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/867
|
0.23%
2/874
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Pharyngoesophageal diverticulum
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/867
|
0.11%
1/874
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
2/867
|
0.34%
3/874
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
1/867
|
0.23%
2/874
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
3/867
|
0.00%
0/874
|
|
General disorders
Adverse drug reaction
|
0.00%
0/867
|
0.11%
1/874
|
|
General disorders
Asthenia
|
0.58%
5/867
|
0.23%
2/874
|
|
General disorders
Chest discomfort
|
0.23%
2/867
|
0.00%
0/874
|
|
General disorders
Chest pain
|
1.7%
15/867
|
1.6%
14/874
|
|
General disorders
Cyst
|
0.00%
0/867
|
0.23%
2/874
|
|
General disorders
Death
|
0.23%
2/867
|
0.57%
5/874
|
|
General disorders
Drug interaction
|
0.12%
1/867
|
0.00%
0/874
|
|
General disorders
Facial pain
|
0.00%
0/867
|
0.11%
1/874
|
|
General disorders
Fatigue
|
0.00%
0/867
|
0.11%
1/874
|
|
General disorders
Gait disturbance
|
0.12%
1/867
|
0.00%
0/874
|
|
General disorders
Medical device complication
|
0.12%
1/867
|
0.00%
0/874
|
|
General disorders
Non-cardiac chest pain
|
0.23%
2/867
|
0.23%
2/874
|
|
General disorders
Pain
|
1.0%
9/867
|
0.46%
4/874
|
|
General disorders
Ulcer
|
0.23%
2/867
|
0.11%
1/874
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/867
|
0.11%
1/874
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/867
|
0.11%
1/874
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
2/867
|
0.34%
3/874
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/867
|
0.34%
3/874
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.12%
1/867
|
0.00%
0/874
|
|
Immune system disorders
Drug hypersensitivity
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Abscess
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Appendicitis
|
0.46%
4/867
|
0.11%
1/874
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Bacterial infection
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Bronchitis
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Cellulitis
|
0.46%
4/867
|
0.46%
4/874
|
|
Infections and infestations
Clostridial infection
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Coccidioidomycosis
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Cystitis
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Diverticulitis
|
0.23%
2/867
|
0.34%
3/874
|
|
Infections and infestations
Gastroenteritis
|
0.23%
2/867
|
0.00%
0/874
|
|
Infections and infestations
Groin abscess
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Herpes zoster
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Hip infection
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Infection
|
0.12%
1/867
|
0.46%
4/874
|
|
Infections and infestations
Influenza
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Intervertebral discitis
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Kidney infection
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Labyrinthitis
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Liver abscess
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Lung infection
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Meningitis bacterial
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Meningitis viral
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Oesophageal infection
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Osteomyelitis
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Peridiverticulitis
|
0.00%
0/867
|
0.11%
1/874
|
|
Infections and infestations
Pharyngitis
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Pneumonia
|
2.1%
18/867
|
1.8%
16/874
|
|
Infections and infestations
Pyelonephritis
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Sepsis
|
0.12%
1/867
|
0.11%
1/874
|
|
Infections and infestations
Septic shock
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Sinusitis
|
0.12%
1/867
|
0.00%
0/874
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
2/867
|
0.00%
0/874
|
|
Infections and infestations
Urinary tract infection
|
1.0%
9/867
|
0.57%
5/874
|
|
Infections and infestations
Urosepsis
|
0.46%
4/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.12%
1/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Concussion
|
0.12%
1/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Contusion
|
0.23%
2/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
11/867
|
0.80%
7/874
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.58%
5/867
|
0.34%
3/874
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.12%
1/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Fracture
|
0.12%
1/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
12/867
|
1.1%
10/874
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.23%
2/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Injury
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Laceration
|
0.46%
4/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.23%
2/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.46%
4/867
|
0.23%
2/874
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.12%
1/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.35%
3/867
|
0.23%
2/874
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.23%
2/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/867
|
0.11%
1/874
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.12%
1/867
|
0.34%
3/874
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Investigations
Blood sodium decreased
|
0.00%
0/867
|
0.11%
1/874
|
|
Investigations
Catheterisation cardiac
|
0.12%
1/867
|
0.00%
0/874
|
|
Investigations
Heart rate irregular
|
0.12%
1/867
|
0.11%
1/874
|
|
Investigations
Hepatic enzyme increased
|
0.12%
1/867
|
0.00%
0/874
|
|
Investigations
Investigation
|
0.00%
0/867
|
0.11%
1/874
|
|
Investigations
Medical observation
|
0.00%
0/867
|
0.11%
1/874
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/867
|
0.11%
1/874
|
|
Investigations
Weight decreased
|
0.23%
2/867
|
0.00%
0/874
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
2/867
|
0.23%
2/874
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.12%
1/867
|
0.00%
0/874
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/867
|
0.11%
1/874
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/867
|
0.11%
1/874
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.23%
2/867
|
0.00%
0/874
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.12%
1/867
|
0.11%
1/874
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
7/867
|
0.34%
3/874
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.69%
6/867
|
1.5%
13/874
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/867
|
0.34%
3/874
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.23%
2/867
|
0.23%
2/874
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
9/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.35%
3/867
|
1.3%
11/874
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.12%
1/867
|
0.23%
2/874
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
16/867
|
1.7%
15/874
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.23%
2/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
2/867
|
0.11%
1/874
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.23%
2/867
|
0.11%
1/874
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.3%
11/867
|
0.46%
4/874
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.23%
2/867
|
0.23%
2/874
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.23%
2/867
|
0.23%
2/874
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.12%
1/867
|
0.00%
0/874
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.23%
2/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.12%
1/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.23%
2/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the pancreas
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chordoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.35%
3/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell carcinoma of the respiratory tract stage unspecified
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia plasmacytic
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.23%
2/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.35%
3/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/867
|
0.23%
2/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.12%
1/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.35%
3/867
|
0.23%
2/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/867
|
0.11%
1/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.35%
3/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
2/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.12%
1/867
|
0.00%
0/874
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/867
|
0.23%
2/874
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Cerebral infarction
|
0.35%
3/867
|
0.00%
0/874
|
|
Nervous system disorders
Cerebrovascular accident
|
0.69%
6/867
|
0.69%
6/874
|
|
Nervous system disorders
Cognitive disorder
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Convulsion
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Dementia
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Dizziness
|
0.58%
5/867
|
0.11%
1/874
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Epilepsy
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Facial palsy
|
0.12%
1/867
|
0.11%
1/874
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.23%
2/867
|
0.00%
0/874
|
|
Nervous system disorders
Headache
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Hypoaesthesia
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Intracranial hypotension
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
2/867
|
0.00%
0/874
|
|
Nervous system disorders
Lethargy
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Loss of consciousness
|
0.23%
2/867
|
0.34%
3/874
|
|
Nervous system disorders
Migraine
|
0.12%
1/867
|
0.11%
1/874
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/867
|
0.11%
1/874
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Nerve compression
|
0.12%
1/867
|
0.11%
1/874
|
|
Nervous system disorders
Neuropathy peripheral
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Parkinson's disease
|
0.46%
4/867
|
0.46%
4/874
|
|
Nervous system disorders
Presyncope
|
0.35%
3/867
|
0.23%
2/874
|
|
Nervous system disorders
Sciatica
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Spinal cord compression
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Spinal cord disorder
|
0.12%
1/867
|
0.00%
0/874
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.23%
2/867
|
0.00%
0/874
|
|
Nervous system disorders
Syncope
|
1.7%
15/867
|
1.4%
12/874
|
|
Nervous system disorders
Transient ischaemic attack
|
0.69%
6/867
|
0.46%
4/874
|
|
Nervous system disorders
Tremor
|
0.23%
2/867
|
0.00%
0/874
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Aggression
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Anxiety
|
0.35%
3/867
|
0.11%
1/874
|
|
Psychiatric disorders
Confusional state
|
0.35%
3/867
|
0.23%
2/874
|
|
Psychiatric disorders
Delusion
|
0.12%
1/867
|
0.11%
1/874
|
|
Psychiatric disorders
Depression
|
0.23%
2/867
|
0.11%
1/874
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/867
|
0.11%
1/874
|
|
Psychiatric disorders
Food aversion
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Hallucination
|
0.35%
3/867
|
0.34%
3/874
|
|
Psychiatric disorders
Hallucination, visual
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Intentional self-injury
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Major depression
|
0.00%
0/867
|
0.11%
1/874
|
|
Psychiatric disorders
Mania
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Mental disorder
|
0.23%
2/867
|
0.11%
1/874
|
|
Psychiatric disorders
Mental status changes
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/867
|
0.11%
1/874
|
|
Psychiatric disorders
Paranoia
|
0.12%
1/867
|
0.00%
0/874
|
|
Psychiatric disorders
Psychotic disorder
|
0.12%
1/867
|
0.11%
1/874
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/867
|
0.23%
2/874
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/867
|
0.11%
1/874
|
|
Renal and urinary disorders
Bladder prolapse
|
0.23%
2/867
|
0.34%
3/874
|
|
Renal and urinary disorders
Contracted bladder
|
0.00%
0/867
|
0.11%
1/874
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.69%
6/867
|
0.23%
2/874
|
|
Renal and urinary disorders
Renal colic
|
0.23%
2/867
|
0.00%
0/874
|
|
Renal and urinary disorders
Renal failure
|
0.12%
1/867
|
0.00%
0/874
|
|
Renal and urinary disorders
Renal failure acute
|
0.12%
1/867
|
0.00%
0/874
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/867
|
0.11%
1/874
|
|
Renal and urinary disorders
Urinary retention
|
0.46%
4/867
|
0.11%
1/874
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.23%
2/867
|
0.34%
3/874
|
|
Reproductive system and breast disorders
Cystocele
|
0.23%
2/867
|
0.23%
2/874
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/867
|
0.11%
1/874
|
|
Reproductive system and breast disorders
Joint dislocation
|
0.00%
0/867
|
0.11%
1/874
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.12%
1/867
|
0.00%
0/874
|
|
Reproductive system and breast disorders
Prostatitis
|
0.12%
1/867
|
0.11%
1/874
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.46%
4/867
|
0.00%
0/874
|
|
Reproductive system and breast disorders
Rectocele
|
0.12%
1/867
|
0.00%
0/874
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/867
|
0.11%
1/874
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.12%
1/867
|
0.00%
0/874
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.12%
1/867
|
0.11%
1/874
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/867
|
0.11%
1/874
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.12%
1/867
|
0.00%
0/874
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
0.00%
0/867
|
0.11%
1/874
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.12%
1/867
|
0.00%
0/874
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.12%
1/867
|
0.00%
0/874
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
6/867
|
0.23%
2/874
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.12%
1/867
|
0.00%
0/874
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/867
|
0.23%
2/874
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.46%
4/867
|
0.23%
2/874
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
2/867
|
0.00%
0/874
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
11/867
|
0.80%
7/874
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
0.00%
0/867
|
0.11%
1/874
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.12%
1/867
|
0.00%
0/874
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.12%
1/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Angioplasty
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.35%
3/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Benign tumour excision
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/867
|
0.23%
2/874
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/867
|
0.34%
3/874
|
|
Surgical and medical procedures
Colporrhaphy
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Deep brain stimulation
|
3.1%
27/867
|
2.7%
24/874
|
|
Surgical and medical procedures
Heart valve replacement
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Hernia repair
|
0.12%
1/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.58%
5/867
|
0.23%
2/874
|
|
Surgical and medical procedures
Hysterectomy
|
0.23%
2/867
|
0.34%
3/874
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.12%
1/867
|
0.57%
5/874
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.58%
5/867
|
0.34%
3/874
|
|
Surgical and medical procedures
Large intestine anastomosis
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Nephrectomy
|
0.12%
1/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Prophylaxis of nausea and vomiting
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.00%
0/867
|
0.11%
1/874
|
|
Surgical and medical procedures
Spinal decompression
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.23%
2/867
|
0.34%
3/874
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.12%
1/867
|
0.34%
3/874
|
|
Surgical and medical procedures
Stent placement
|
0.23%
2/867
|
0.23%
2/874
|
|
Surgical and medical procedures
Surgery
|
0.12%
1/867
|
0.23%
2/874
|
|
Surgical and medical procedures
Thalamotomy
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Thyroidectomy
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Tracheostomy
|
0.12%
1/867
|
0.00%
0/874
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.12%
1/867
|
0.23%
2/874
|
|
Vascular disorders
Aneurysm
|
0.12%
1/867
|
0.00%
0/874
|
|
Vascular disorders
Aortic aneurysm
|
0.35%
3/867
|
0.11%
1/874
|
|
Vascular disorders
Aortic dissection
|
0.12%
1/867
|
0.00%
0/874
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/867
|
0.11%
1/874
|
|
Vascular disorders
Aortic stenosis
|
0.12%
1/867
|
0.00%
0/874
|
|
Vascular disorders
Arterial stenosis
|
0.12%
1/867
|
0.00%
0/874
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/867
|
0.69%
6/874
|
|
Vascular disorders
Embolism
|
0.00%
0/867
|
0.11%
1/874
|
|
Vascular disorders
Fibromuscular dysplasia
|
0.00%
0/867
|
0.11%
1/874
|
|
Vascular disorders
Hypertension
|
0.46%
4/867
|
0.00%
0/874
|
|
Vascular disorders
Hypertensive crisis
|
0.12%
1/867
|
0.00%
0/874
|
|
Vascular disorders
Hypotension
|
0.35%
3/867
|
0.23%
2/874
|
|
Vascular disorders
Orthostatic hypotension
|
0.23%
2/867
|
0.34%
3/874
|
|
Vascular disorders
Thrombosis
|
0.12%
1/867
|
0.11%
1/874
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/867
|
0.11%
1/874
|
Other adverse events
| Measure |
Placebo
n=867 participants at risk
placebo: an inactive substance
|
Creatine
n=874 participants at risk
creatine 5 grams twice daily
|
|---|---|---|
|
Eye disorders
Cataract
|
5.9%
51/867
|
5.0%
44/874
|
|
Gastrointestinal disorders
Constipation
|
12.3%
107/867
|
13.8%
121/874
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
50/867
|
7.4%
65/874
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
53/867
|
4.5%
39/874
|
|
Gastrointestinal disorders
Nausea
|
11.6%
101/867
|
11.3%
99/874
|
|
General disorders
Fatigue
|
5.4%
47/867
|
5.5%
48/874
|
|
General disorders
Oedema
|
16.0%
139/867
|
17.6%
154/874
|
|
Gastrointestinal disorders
Pain
|
14.1%
122/867
|
13.8%
121/874
|
|
Infections and infestations
Sinusitis
|
5.3%
46/867
|
6.3%
55/874
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
63/867
|
7.6%
66/874
|
|
Infections and infestations
Urinary tract infection
|
12.6%
109/867
|
9.7%
85/874
|
|
Injury, poisoning and procedural complications
Fall
|
11.2%
97/867
|
10.4%
91/874
|
|
Investigations
Weight decreased
|
5.8%
50/867
|
4.0%
35/874
|
|
Investigations
Weight increased
|
11.6%
101/867
|
15.7%
137/874
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
64/867
|
9.3%
81/874
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
106/867
|
12.0%
105/874
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
53/867
|
11.6%
101/874
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
45/867
|
4.9%
43/874
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
31/867
|
5.4%
47/874
|
|
Nervous system disorders
Dizziness
|
9.3%
81/867
|
7.1%
62/874
|
|
Nervous system disorders
Somnolence
|
7.7%
67/867
|
7.0%
61/874
|
|
Psychiatric disorders
Anxiety
|
8.9%
77/867
|
7.4%
65/874
|
|
Psychiatric disorders
Depression
|
12.2%
106/867
|
11.4%
100/874
|
|
Psychiatric disorders
Hallucination
|
4.5%
39/867
|
5.1%
45/874
|
|
Psychiatric disorders
Insomnia
|
11.6%
101/867
|
11.0%
96/874
|
|
Renal and urinary disorders
Pollakiuria
|
5.8%
50/867
|
3.9%
34/874
|
|
Renal and urinary disorders
Proteinuria
|
5.7%
49/867
|
5.4%
47/874
|
|
Vascular disorders
Hypertension
|
5.3%
46/867
|
5.3%
46/874
|
Additional Information
Karl Kieburtz, Director of CTSI
University of Rochester
Phone: 585-275-0553
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place