Time Frame |
[Not Specified]
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Placebo
|
Creatine
|
Arm/Group Description |
placebo: an inactive substance
|
creatine 5 grams twice daily
|
Arm/Group Description |
placebo: an inactive substance
|
creatine 5 grams twice daily
|
|
|
Placebo
|
Creatine
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
|
|
Placebo
|
Creatine
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
347/867 (40.02%) |
315/874 (36.04%) |
Blood and lymphatic system disorders |
|
|
Anaemia |
0/867 (0.00%) |
1/874 (0.11%) |
Haemolytic anaemia |
1/867 (0.12%) |
0/874 (0.00%) |
Cardiac disorders |
|
|
Angina pectoris |
1/867 (0.12%) |
2/874 (0.23%) |
Angina unstable |
1/867 (0.12%) |
1/874 (0.11%) |
Aortic valve disease |
1/867 (0.12%) |
0/874 (0.00%) |
Aortic valve incompetence |
1/867 (0.12%) |
0/874 (0.00%) |
Atrial fibrillation |
4/867 (0.46%) |
9/874 (1.03%) |
Bradycardia |
4/867 (0.46%) |
0/874 (0.00%) |
Brugada syndrome |
0/867 (0.00%) |
1/874 (0.11%) |
Cardiac arrest |
4/867 (0.46%) |
7/874 (0.80%) |
Cardiac disorder |
1/867 (0.12%) |
0/874 (0.00%) |
Cardiac failure |
1/867 (0.12%) |
0/874 (0.00%) |
Cardiac failure congestive |
1/867 (0.12%) |
3/874 (0.34%) |
Cardio-respiratory arrest |
1/867 (0.12%) |
3/874 (0.34%) |
Cardiopulmonary failure |
1/867 (0.12%) |
0/874 (0.00%) |
Coronary artery disease |
3/867 (0.35%) |
4/874 (0.46%) |
Coronary artery occlusion |
1/867 (0.12%) |
0/874 (0.00%) |
Coronary artery stenosis |
1/867 (0.12%) |
1/874 (0.11%) |
Diastolic dysfunction |
1/867 (0.12%) |
0/874 (0.00%) |
Hypertensive heart disease |
1/867 (0.12%) |
0/874 (0.00%) |
Mitral valve stenosis |
0/867 (0.00%) |
1/874 (0.11%) |
Myocardial infarction |
8/867 (0.92%) |
12/874 (1.37%) |
Myocardial ischaemia |
0/867 (0.00%) |
2/874 (0.23%) |
Palpitations |
1/867 (0.12%) |
0/874 (0.00%) |
Sick sinus syndrome |
0/867 (0.00%) |
1/874 (0.11%) |
Ventricular fibrillation |
1/867 (0.12%) |
0/874 (0.00%) |
Ventricular tachycardia |
0/867 (0.00%) |
1/874 (0.11%) |
Congenital, familial and genetic disorders |
|
|
Congenital coronary artery malformation |
1/867 (0.12%) |
0/874 (0.00%) |
Factor V deficiency |
0/867 (0.00%) |
1/874 (0.11%) |
Ear and labyrinth disorders |
|
|
Vertigo |
4/867 (0.46%) |
1/874 (0.11%) |
Vertigo positional |
0/867 (0.00%) |
1/874 (0.11%) |
Endocrine disorders |
|
|
Goitre |
2/867 (0.23%) |
0/874 (0.00%) |
Hyperparathyroidism |
1/867 (0.12%) |
0/874 (0.00%) |
Eye disorders |
|
|
Amaurosis fugax |
0/867 (0.00%) |
1/874 (0.11%) |
Blindness transient |
0/867 (0.00%) |
1/874 (0.11%) |
Macular oedema |
1/867 (0.12%) |
0/874 (0.00%) |
Gastrointestinal disorders |
|
|
Abdominal adhesions |
1/867 (0.12%) |
0/874 (0.00%) |
Abdominal hernia |
0/867 (0.00%) |
2/874 (0.23%) |
Abdominal pain |
2/867 (0.23%) |
2/874 (0.23%) |
Abdominal pain upper |
1/867 (0.12%) |
0/874 (0.00%) |
Anal fissure |
0/867 (0.00%) |
1/874 (0.11%) |
Ascites |
0/867 (0.00%) |
1/874 (0.11%) |
Colitis |
0/867 (0.00%) |
1/874 (0.11%) |
Colitis ischaemic |
0/867 (0.00%) |
3/874 (0.34%) |
Constipation |
1/867 (0.12%) |
1/874 (0.11%) |
Diarrhoea |
2/867 (0.23%) |
1/874 (0.11%) |
Dyspepsia |
1/867 (0.12%) |
0/874 (0.00%) |
Dysphagia |
1/867 (0.12%) |
0/874 (0.00%) |
Faecaloma |
1/867 (0.12%) |
0/874 (0.00%) |
Gastrointestinal haemorrhage |
2/867 (0.23%) |
1/874 (0.11%) |
Hiatus hernia |
0/867 (0.00%) |
1/874 (0.11%) |
Ileus |
1/867 (0.12%) |
2/874 (0.23%) |
Impaired gastric emptying |
0/867 (0.00%) |
1/874 (0.11%) |
Inguinal hernia |
1/867 (0.12%) |
1/874 (0.11%) |
Intestinal obstruction |
3/867 (0.35%) |
6/874 (0.69%) |
Nausea |
2/867 (0.23%) |
0/874 (0.00%) |
Oesophageal achalasia |
0/867 (0.00%) |
2/874 (0.23%) |
Oesophageal stenosis |
0/867 (0.00%) |
1/874 (0.11%) |
Oesophageal ulcer haemorrhage |
0/867 (0.00%) |
1/874 (0.11%) |
Pharyngoesophageal diverticulum |
0/867 (0.00%) |
1/874 (0.11%) |
Rectal haemorrhage |
0/867 (0.00%) |
1/874 (0.11%) |
Small intestinal obstruction |
2/867 (0.23%) |
3/874 (0.34%) |
Upper gastrointestinal haemorrhage |
1/867 (0.12%) |
2/874 (0.23%) |
Vomiting |
3/867 (0.35%) |
0/874 (0.00%) |
General disorders |
|
|
Adverse drug reaction |
0/867 (0.00%) |
1/874 (0.11%) |
Asthenia |
5/867 (0.58%) |
2/874 (0.23%) |
Chest discomfort |
2/867 (0.23%) |
0/874 (0.00%) |
Chest pain |
15/867 (1.73%) |
14/874 (1.60%) |
Cyst |
0/867 (0.00%) |
2/874 (0.23%) |
Death |
2/867 (0.23%) |
5/874 (0.57%) |
Drug interaction |
1/867 (0.12%) |
0/874 (0.00%) |
Facial pain |
0/867 (0.00%) |
1/874 (0.11%) |
Fatigue |
0/867 (0.00%) |
1/874 (0.11%) |
Gait disturbance |
1/867 (0.12%) |
0/874 (0.00%) |
Medical device complication |
1/867 (0.12%) |
0/874 (0.00%) |
Non-cardiac chest pain |
2/867 (0.23%) |
2/874 (0.23%) |
Pain |
9/867 (1.04%) |
4/874 (0.46%) |
Ulcer |
2/867 (0.23%) |
1/874 (0.11%) |
Hepatobiliary disorders |
|
|
Bile duct stone |
0/867 (0.00%) |
1/874 (0.11%) |
Cholangitis |
0/867 (0.00%) |
1/874 (0.11%) |
Cholecystitis |
2/867 (0.23%) |
3/874 (0.34%) |
Cholelithiasis |
0/867 (0.00%) |
3/874 (0.34%) |
Gallbladder disorder |
1/867 (0.12%) |
0/874 (0.00%) |
Immune system disorders |
|
|
Drug hypersensitivity |
1/867 (0.12%) |
1/874 (0.11%) |
Infections and infestations |
|
|
Abscess |
0/867 (0.00%) |
1/874 (0.11%) |
Appendicitis |
4/867 (0.46%) |
1/874 (0.11%) |
Appendicitis perforated |
0/867 (0.00%) |
1/874 (0.11%) |
Bacterial infection |
1/867 (0.12%) |
0/874 (0.00%) |
Bronchitis |
1/867 (0.12%) |
1/874 (0.11%) |
Cellulitis |
4/867 (0.46%) |
4/874 (0.46%) |
Clostridial infection |
1/867 (0.12%) |
1/874 (0.11%) |
Clostridium difficile colitis |
0/867 (0.00%) |
1/874 (0.11%) |
Coccidioidomycosis |
1/867 (0.12%) |
0/874 (0.00%) |
Creutzfeldt-Jakob disease |
1/867 (0.12%) |
0/874 (0.00%) |
Cystitis |
1/867 (0.12%) |
1/874 (0.11%) |
Cytomegalovirus infection |
0/867 (0.00%) |
1/874 (0.11%) |
Diverticulitis |
2/867 (0.23%) |
3/874 (0.34%) |
Gastroenteritis |
2/867 (0.23%) |
0/874 (0.00%) |
Groin abscess |
0/867 (0.00%) |
1/874 (0.11%) |
Herpes zoster |
1/867 (0.12%) |
0/874 (0.00%) |
Hip infection |
1/867 (0.12%) |
0/874 (0.00%) |
Infection |
1/867 (0.12%) |
4/874 (0.46%) |
Influenza |
1/867 (0.12%) |
1/874 (0.11%) |
Intervertebral discitis |
1/867 (0.12%) |
0/874 (0.00%) |
Kidney infection |
1/867 (0.12%) |
1/874 (0.11%) |
Labyrinthitis |
1/867 (0.12%) |
0/874 (0.00%) |
Liver abscess |
1/867 (0.12%) |
0/874 (0.00%) |
Lung infection |
0/867 (0.00%) |
1/874 (0.11%) |
Meningitis bacterial |
1/867 (0.12%) |
0/874 (0.00%) |
Meningitis viral |
1/867 (0.12%) |
0/874 (0.00%) |
Oesophageal infection |
1/867 (0.12%) |
0/874 (0.00%) |
Osteomyelitis |
1/867 (0.12%) |
0/874 (0.00%) |
Peridiverticulitis |
0/867 (0.00%) |
1/874 (0.11%) |
Pharyngitis |
1/867 (0.12%) |
0/874 (0.00%) |
Pneumonia |
18/867 (2.08%) |
16/874 (1.83%) |
Pyelonephritis |
1/867 (0.12%) |
1/874 (0.11%) |
Sepsis |
1/867 (0.12%) |
1/874 (0.11%) |
Septic shock |
1/867 (0.12%) |
0/874 (0.00%) |
Sinusitis |
1/867 (0.12%) |
0/874 (0.00%) |
Staphylococcal infection |
2/867 (0.23%) |
0/874 (0.00%) |
Urinary tract infection |
9/867 (1.04%) |
5/874 (0.57%) |
Urosepsis |
4/867 (0.46%) |
0/874 (0.00%) |
Injury, poisoning and procedural complications |
|
|
Accidental overdose |
1/867 (0.12%) |
1/874 (0.11%) |
Arterial injury |
0/867 (0.00%) |
1/874 (0.11%) |
Avulsion fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Cervical vertebral fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Clavicle fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Concussion |
1/867 (0.12%) |
1/874 (0.11%) |
Contusion |
2/867 (0.23%) |
0/874 (0.00%) |
Fall |
11/867 (1.27%) |
7/874 (0.80%) |
Femoral neck fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Femur fracture |
5/867 (0.58%) |
3/874 (0.34%) |
Fibula fracture |
1/867 (0.12%) |
1/874 (0.11%) |
Forearm fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Foreign body |
1/867 (0.12%) |
0/874 (0.00%) |
Fracture |
1/867 (0.12%) |
1/874 (0.11%) |
Hand fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Heat exhaustion |
0/867 (0.00%) |
1/874 (0.11%) |
Hip fracture |
12/867 (1.38%) |
10/874 (1.14%) |
Humerus fracture |
2/867 (0.23%) |
0/874 (0.00%) |
Injury |
1/867 (0.12%) |
0/874 (0.00%) |
Joint sprain |
0/867 (0.00%) |
1/874 (0.11%) |
Laceration |
4/867 (0.46%) |
1/874 (0.11%) |
Ligament rupture |
0/867 (0.00%) |
1/874 (0.11%) |
Limb crushing injury |
1/867 (0.12%) |
0/874 (0.00%) |
Limb injury |
1/867 (0.12%) |
0/874 (0.00%) |
Lower limb fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Lumbar vertebral fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Meniscus lesion |
0/867 (0.00%) |
1/874 (0.11%) |
Overdose |
0/867 (0.00%) |
1/874 (0.11%) |
Pelvic fracture |
2/867 (0.23%) |
1/874 (0.11%) |
Periorbital haematoma |
1/867 (0.12%) |
0/874 (0.00%) |
Rib fracture |
4/867 (0.46%) |
2/874 (0.23%) |
Road traffic accident |
1/867 (0.12%) |
1/874 (0.11%) |
Spinal compression fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Sternal fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Stress fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Subdural haematoma |
3/867 (0.35%) |
2/874 (0.23%) |
Subdural haemorrhage |
1/867 (0.12%) |
0/874 (0.00%) |
Tendon injury |
2/867 (0.23%) |
0/874 (0.00%) |
Tendon rupture |
0/867 (0.00%) |
1/874 (0.11%) |
Thoracic vertebral fracture |
0/867 (0.00%) |
1/874 (0.11%) |
Tibia fracture |
1/867 (0.12%) |
3/874 (0.34%) |
Ulna fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Upper limb fracture |
1/867 (0.12%) |
0/874 (0.00%) |
Investigations |
|
|
Blood sodium decreased |
0/867 (0.00%) |
1/874 (0.11%) |
Catheterisation cardiac |
1/867 (0.12%) |
0/874 (0.00%) |
Heart rate irregular |
1/867 (0.12%) |
1/874 (0.11%) |
Hepatic enzyme increased |
1/867 (0.12%) |
0/874 (0.00%) |
Investigation |
0/867 (0.00%) |
1/874 (0.11%) |
Medical observation |
0/867 (0.00%) |
1/874 (0.11%) |
Prostatic specific antigen increased |
0/867 (0.00%) |
1/874 (0.11%) |
Weight decreased |
2/867 (0.23%) |
0/874 (0.00%) |
Metabolism and nutrition disorders |
|
|
Dehydration |
2/867 (0.23%) |
2/874 (0.23%) |
Diabetes mellitus |
1/867 (0.12%) |
0/874 (0.00%) |
Failure to thrive |
0/867 (0.00%) |
1/874 (0.11%) |
Hypercalcaemia |
0/867 (0.00%) |
1/874 (0.11%) |
Hypokalaemia |
2/867 (0.23%) |
0/874 (0.00%) |
Hyponatraemia |
1/867 (0.12%) |
1/874 (0.11%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
7/867 (0.81%) |
3/874 (0.34%) |
Arthritis |
6/867 (0.69%) |
13/874 (1.49%) |
Back pain |
1/867 (0.12%) |
3/874 (0.34%) |
Cervical spinal stenosis |
1/867 (0.12%) |
0/874 (0.00%) |
Exostosis |
0/867 (0.00%) |
1/874 (0.11%) |
Fall |
1/867 (0.12%) |
0/874 (0.00%) |
Intervertebral disc degeneration |
2/867 (0.23%) |
2/874 (0.23%) |
Intervertebral disc protrusion |
9/867 (1.04%) |
0/874 (0.00%) |
Joint instability |
1/867 (0.12%) |
0/874 (0.00%) |
Lumbar spinal stenosis |
3/867 (0.35%) |
11/874 (1.26%) |
Muscle contracture |
1/867 (0.12%) |
0/874 (0.00%) |
Musculoskeletal pain |
1/867 (0.12%) |
2/874 (0.23%) |
Musculoskeletal stiffness |
1/867 (0.12%) |
0/874 (0.00%) |
Osteoarthritis |
16/867 (1.85%) |
15/874 (1.72%) |
Rhabdomyolysis |
2/867 (0.23%) |
0/874 (0.00%) |
Rotator cuff syndrome |
2/867 (0.23%) |
1/874 (0.11%) |
Scoliosis |
2/867 (0.23%) |
1/874 (0.11%) |
Spinal column stenosis |
11/867 (1.27%) |
4/874 (0.46%) |
Spinal disorder |
1/867 (0.12%) |
0/874 (0.00%) |
Spinal osteoarthritis |
2/867 (0.23%) |
2/874 (0.23%) |
Spondylolisthesis |
2/867 (0.23%) |
2/874 (0.23%) |
Tendonitis |
1/867 (0.12%) |
0/874 (0.00%) |
Vertebral foraminal stenosis |
1/867 (0.12%) |
0/874 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Basal cell carcinoma |
1/867 (0.12%) |
0/874 (0.00%) |
Benign neoplasm |
0/867 (0.00%) |
1/874 (0.11%) |
Bile duct cancer |
0/867 (0.00%) |
1/874 (0.11%) |
Bladder cancer |
2/867 (0.23%) |
1/874 (0.11%) |
Bladder cancer recurrent |
1/867 (0.12%) |
1/874 (0.11%) |
Bladder transitional cell carcinoma |
1/867 (0.12%) |
0/874 (0.00%) |
Brain neoplasm |
0/867 (0.00%) |
1/874 (0.11%) |
Breast cancer |
2/867 (0.23%) |
1/874 (0.11%) |
Breast cancer metastatic |
1/867 (0.12%) |
0/874 (0.00%) |
Carcinoid tumour of the pancreas |
0/867 (0.00%) |
1/874 (0.11%) |
Cervix carcinoma |
1/867 (0.12%) |
0/874 (0.00%) |
Chordoma |
1/867 (0.12%) |
0/874 (0.00%) |
Colon cancer |
3/867 (0.35%) |
1/874 (0.11%) |
Colorectal cancer |
0/867 (0.00%) |
1/874 (0.11%) |
Endometrial cancer |
1/867 (0.12%) |
0/874 (0.00%) |
Gastrointestinal stromal tumour |
1/867 (0.12%) |
0/874 (0.00%) |
Glioblastoma multiforme |
1/867 (0.12%) |
0/874 (0.00%) |
Hepatic neoplasm |
0/867 (0.00%) |
1/874 (0.11%) |
Hepatic neoplasm malignant |
1/867 (0.12%) |
0/874 (0.00%) |
Large cell carcinoma of the respiratory tract stage unspecified |
1/867 (0.12%) |
0/874 (0.00%) |
Leukaemia plasmacytic |
1/867 (0.12%) |
0/874 (0.00%) |
Lung cancer metastatic |
2/867 (0.23%) |
0/874 (0.00%) |
Lung neoplasm |
1/867 (0.12%) |
0/874 (0.00%) |
Lung neoplasm malignant |
1/867 (0.12%) |
1/874 (0.11%) |
Malignant melanoma |
3/867 (0.35%) |
0/874 (0.00%) |
Mantle cell lymphoma |
1/867 (0.12%) |
0/874 (0.00%) |
Metastases to meninges |
0/867 (0.00%) |
1/874 (0.11%) |
Metastasis |
0/867 (0.00%) |
1/874 (0.11%) |
Metastatic neoplasm |
1/867 (0.12%) |
0/874 (0.00%) |
Multiple myeloma |
1/867 (0.12%) |
0/874 (0.00%) |
Non-Hodgkin's lymphoma stage IV |
1/867 (0.12%) |
0/874 (0.00%) |
Ovarian cancer |
0/867 (0.00%) |
2/874 (0.23%) |
Pancreatic carcinoma |
1/867 (0.12%) |
1/874 (0.11%) |
Prostate cancer |
3/867 (0.35%) |
2/874 (0.23%) |
Rectal cancer |
1/867 (0.12%) |
0/874 (0.00%) |
Rectosigmoid cancer |
0/867 (0.00%) |
1/874 (0.11%) |
Renal cell carcinoma |
3/867 (0.35%) |
0/874 (0.00%) |
Small cell lung cancer stage unspecified |
1/867 (0.12%) |
0/874 (0.00%) |
Squamous cell carcinoma |
2/867 (0.23%) |
0/874 (0.00%) |
T-cell lymphoma |
1/867 (0.12%) |
0/874 (0.00%) |
Thyroid cancer |
0/867 (0.00%) |
1/874 (0.11%) |
Nervous system disorders |
|
|
Amyotrophic lateral sclerosis |
0/867 (0.00%) |
1/874 (0.11%) |
Carotid artery occlusion |
0/867 (0.00%) |
2/874 (0.23%) |
Carotid artery stenosis |
0/867 (0.00%) |
1/874 (0.11%) |
Cerebellar haemorrhage |
0/867 (0.00%) |
1/874 (0.11%) |
Cerebral haemorrhage |
1/867 (0.12%) |
0/874 (0.00%) |
Cerebral infarction |
3/867 (0.35%) |
0/874 (0.00%) |
Cerebrovascular accident |
6/867 (0.69%) |
6/874 (0.69%) |
Cognitive disorder |
1/867 (0.12%) |
0/874 (0.00%) |
Convulsion |
0/867 (0.00%) |
1/874 (0.11%) |
Dementia |
1/867 (0.12%) |
0/874 (0.00%) |
Dementia Alzheimer's type |
1/867 (0.12%) |
0/874 (0.00%) |
Dizziness |
5/867 (0.58%) |
1/874 (0.11%) |
Dysarthria |
0/867 (0.00%) |
1/874 (0.11%) |
Encephalopathy |
0/867 (0.00%) |
1/874 (0.11%) |
Epilepsy |
1/867 (0.12%) |
0/874 (0.00%) |
Facial palsy |
1/867 (0.12%) |
1/874 (0.11%) |
Grand mal convulsion |
0/867 (0.00%) |
1/874 (0.11%) |
Guillain-Barre syndrome |
0/867 (0.00%) |
1/874 (0.11%) |
Haemorrhagic stroke |
2/867 (0.23%) |
0/874 (0.00%) |
Headache |
1/867 (0.12%) |
0/874 (0.00%) |
Hypoaesthesia |
1/867 (0.12%) |
0/874 (0.00%) |
Intracranial hypotension |
1/867 (0.12%) |
0/874 (0.00%) |
Ischaemic stroke |
2/867 (0.23%) |
0/874 (0.00%) |
Lethargy |
0/867 (0.00%) |
1/874 (0.11%) |
Loss of consciousness |
2/867 (0.23%) |
3/874 (0.34%) |
Migraine |
1/867 (0.12%) |
1/874 (0.11%) |
Migraine with aura |
0/867 (0.00%) |
1/874 (0.11%) |
Motor dysfunction |
0/867 (0.00%) |
1/874 (0.11%) |
Multiple sclerosis relapse |
1/867 (0.12%) |
0/874 (0.00%) |
Nerve compression |
1/867 (0.12%) |
1/874 (0.11%) |
Neuropathy peripheral |
1/867 (0.12%) |
0/874 (0.00%) |
Parkinson's disease |
4/867 (0.46%) |
4/874 (0.46%) |
Presyncope |
3/867 (0.35%) |
2/874 (0.23%) |
Sciatica |
1/867 (0.12%) |
0/874 (0.00%) |
Spinal cord compression |
1/867 (0.12%) |
0/874 (0.00%) |
Spinal cord disorder |
1/867 (0.12%) |
0/874 (0.00%) |
Subarachnoid haemorrhage |
2/867 (0.23%) |
0/874 (0.00%) |
Syncope |
15/867 (1.73%) |
12/874 (1.37%) |
Transient ischaemic attack |
6/867 (0.69%) |
4/874 (0.46%) |
Tremor |
2/867 (0.23%) |
0/874 (0.00%) |
Pregnancy, puerperium and perinatal conditions |
|
|
Abortion spontaneous |
1/867 (0.12%) |
0/874 (0.00%) |
Psychiatric disorders |
|
|
Aggression |
1/867 (0.12%) |
0/874 (0.00%) |
Anxiety |
3/867 (0.35%) |
1/874 (0.11%) |
Confusional state |
3/867 (0.35%) |
2/874 (0.23%) |
Delusion |
1/867 (0.12%) |
1/874 (0.11%) |
Depression |
2/867 (0.23%) |
1/874 (0.11%) |
Disorientation |
0/867 (0.00%) |
1/874 (0.11%) |
Food aversion |
1/867 (0.12%) |
0/874 (0.00%) |
Hallucination |
3/867 (0.35%) |
3/874 (0.34%) |
Hallucination, visual |
1/867 (0.12%) |
0/874 (0.00%) |
Intentional self-injury |
1/867 (0.12%) |
0/874 (0.00%) |
Major depression |
0/867 (0.00%) |
1/874 (0.11%) |
Mania |
1/867 (0.12%) |
0/874 (0.00%) |
Mental disorder |
2/867 (0.23%) |
1/874 (0.11%) |
Mental status changes |
1/867 (0.12%) |
0/874 (0.00%) |
Panic attack |
0/867 (0.00%) |
1/874 (0.11%) |
Paranoia |
1/867 (0.12%) |
0/874 (0.00%) |
Psychotic disorder |
1/867 (0.12%) |
1/874 (0.11%) |
Suicidal ideation |
0/867 (0.00%) |
2/874 (0.23%) |
Renal and urinary disorders |
|
|
Bladder disorder |
0/867 (0.00%) |
1/874 (0.11%) |
Bladder prolapse |
2/867 (0.23%) |
3/874 (0.34%) |
Contracted bladder |
0/867 (0.00%) |
1/874 (0.11%) |
Nephrolithiasis |
6/867 (0.69%) |
2/874 (0.23%) |
Renal colic |
2/867 (0.23%) |
0/874 (0.00%) |
Renal failure |
1/867 (0.12%) |
0/874 (0.00%) |
Renal failure acute |
1/867 (0.12%) |
0/874 (0.00%) |
Ureteric stenosis |
0/867 (0.00%) |
1/874 (0.11%) |
Urinary incontinence |
0/867 (0.00%) |
1/874 (0.11%) |
Urinary retention |
4/867 (0.46%) |
1/874 (0.11%) |
Reproductive system and breast disorders |
|
|
Benign prostatic hyperplasia |
2/867 (0.23%) |
3/874 (0.34%) |
Cystocele |
2/867 (0.23%) |
2/874 (0.23%) |
Epididymitis |
0/867 (0.00%) |
1/874 (0.11%) |
Joint dislocation |
0/867 (0.00%) |
1/874 (0.11%) |
Ovarian cyst |
1/867 (0.12%) |
0/874 (0.00%) |
Prostatitis |
1/867 (0.12%) |
1/874 (0.11%) |
Prostatomegaly |
4/867 (0.46%) |
0/874 (0.00%) |
Rectocele |
1/867 (0.12%) |
0/874 (0.00%) |
Uterine polyp |
0/867 (0.00%) |
1/874 (0.11%) |
Uterine prolapse |
1/867 (0.12%) |
0/874 (0.00%) |
Vaginal prolapse |
1/867 (0.12%) |
1/874 (0.11%) |
Respiratory, thoracic and mediastinal disorders |
|
|
Acute respiratory failure |
0/867 (0.00%) |
1/874 (0.11%) |
Atelectasis |
1/867 (0.12%) |
0/874 (0.00%) |
Chest Pain |
0/867 (0.00%) |
1/874 (0.11%) |
Chronic obstructive pulmonary disease |
1/867 (0.12%) |
0/874 (0.00%) |
Cough |
1/867 (0.12%) |
0/874 (0.00%) |
Dyspnoea |
6/867 (0.69%) |
2/874 (0.23%) |
Laryngospasm |
1/867 (0.12%) |
0/874 (0.00%) |
Pleural effusion |
0/867 (0.00%) |
2/874 (0.23%) |
Pneumonia aspiration |
4/867 (0.46%) |
2/874 (0.23%) |
Pneumothorax |
2/867 (0.23%) |
0/874 (0.00%) |
Pulmonary embolism |
11/867 (1.27%) |
7/874 (0.80%) |
Pulmonary interstitial emphysema syndrome |
0/867 (0.00%) |
1/874 (0.11%) |
Respiratory arrest |
1/867 (0.12%) |
0/874 (0.00%) |
Skin and subcutaneous tissue disorders |
|
|
Angioedema |
1/867 (0.12%) |
1/874 (0.11%) |
Surgical and medical procedures |
|
|
Angioplasty |
1/867 (0.12%) |
0/874 (0.00%) |
Aortic valve replacement |
3/867 (0.35%) |
0/874 (0.00%) |
Appendicectomy |
0/867 (0.00%) |
1/874 (0.11%) |
Benign tumour excision |
1/867 (0.12%) |
0/874 (0.00%) |
Cardiac pacemaker insertion |
0/867 (0.00%) |
2/874 (0.23%) |
Cholecystectomy |
0/867 (0.00%) |
3/874 (0.34%) |
Colporrhaphy |
0/867 (0.00%) |
1/874 (0.11%) |
Deep brain stimulation |
27/867 (3.11%) |
24/874 (2.75%) |
Heart valve replacement |
1/867 (0.12%) |
0/874 (0.00%) |
Hernia hiatus repair |
0/867 (0.00%) |
1/874 (0.11%) |
Hernia repair |
1/867 (0.12%) |
1/874 (0.11%) |
Hip arthroplasty |
5/867 (0.58%) |
2/874 (0.23%) |
Hysterectomy |
2/867 (0.23%) |
3/874 (0.34%) |
Joint arthroplasty |
1/867 (0.12%) |
5/874 (0.57%) |
Knee arthroplasty |
5/867 (0.58%) |
3/874 (0.34%) |
Large intestine anastomosis |
0/867 (0.00%) |
1/874 (0.11%) |
Meniscus operation |
0/867 (0.00%) |
1/874 (0.11%) |
Mitral valve replacement |
1/867 (0.12%) |
0/874 (0.00%) |
Nephrectomy |
1/867 (0.12%) |
1/874 (0.11%) |
Prophylaxis of nausea and vomiting |
0/867 (0.00%) |
1/874 (0.11%) |
Prostatectomy |
0/867 (0.00%) |
1/874 (0.11%) |
Shoulder arthroplasty |
0/867 (0.00%) |
1/874 (0.11%) |
Spinal decompression |
1/867 (0.12%) |
0/874 (0.00%) |
Spinal fusion surgery |
2/867 (0.23%) |
3/874 (0.34%) |
Spinal laminectomy |
1/867 (0.12%) |
3/874 (0.34%) |
Stent placement |
2/867 (0.23%) |
2/874 (0.23%) |
Surgery |
1/867 (0.12%) |
2/874 (0.23%) |
Thalamotomy |
1/867 (0.12%) |
0/874 (0.00%) |
Thyroidectomy |
1/867 (0.12%) |
0/874 (0.00%) |
Tracheostomy |
1/867 (0.12%) |
0/874 (0.00%) |
Transurethral prostatectomy |
1/867 (0.12%) |
2/874 (0.23%) |
Vascular disorders |
|
|
Aneurysm |
1/867 (0.12%) |
0/874 (0.00%) |
Aortic aneurysm |
3/867 (0.35%) |
1/874 (0.11%) |
Aortic dissection |
1/867 (0.12%) |
0/874 (0.00%) |
Aortic occlusion |
0/867 (0.00%) |
1/874 (0.11%) |
Aortic stenosis |
1/867 (0.12%) |
0/874 (0.00%) |
Arterial stenosis |
1/867 (0.12%) |
0/874 (0.00%) |
Deep vein thrombosis |
0/867 (0.00%) |
6/874 (0.69%) |
Embolism |
0/867 (0.00%) |
1/874 (0.11%) |
Fibromuscular dysplasia |
0/867 (0.00%) |
1/874 (0.11%) |
Hypertension |
4/867 (0.46%) |
0/874 (0.00%) |
Hypertensive crisis |
1/867 (0.12%) |
0/874 (0.00%) |
Hypotension |
3/867 (0.35%) |
2/874 (0.23%) |
Orthostatic hypotension |
2/867 (0.23%) |
3/874 (0.34%) |
Thrombosis |
1/867 (0.12%) |
1/874 (0.11%) |
Venous thrombosis |
0/867 (0.00%) |
1/874 (0.11%) |
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Placebo
|
Creatine
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
687/867 (79.24%) |
698/874 (79.86%) |
Eye disorders |
|
|
Cataract |
51/867 (5.88%) |
44/874 (5.03%) |
Gastrointestinal disorders |
|
|
Constipation |
107/867 (12.34%) |
121/874 (13.84%) |
Diarrhoea |
50/867 (5.77%) |
65/874 (7.44%) |
Gastrooesophageal reflux disease |
53/867 (6.11%) |
39/874 (4.46%) |
Nausea |
101/867 (11.65%) |
99/874 (11.33%) |
Pain |
122/867 (14.07%) |
121/874 (13.84%) |
General disorders |
|
|
Fatigue |
47/867 (5.42%) |
48/874 (5.49%) |
Oedema |
139/867 (16.03%) |
154/874 (17.62%) |
Infections and infestations |
|
|
Sinusitis |
46/867 (5.31%) |
55/874 (6.29%) |
Upper respiratory tract infection |
63/867 (7.27%) |
66/874 (7.55%) |
Urinary tract infection |
109/867 (12.57%) |
85/874 (9.73%) |
Injury, poisoning and procedural complications |
|
|
Fall |
97/867 (11.19%) |
91/874 (10.41%) |
Investigations |
|
|
Weight decreased |
50/867 (5.77%) |
35/874 (4.00%) |
Weight increased |
101/867 (11.65%) |
137/874 (15.68%) |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
64/867 (7.38%) |
81/874 (9.27%) |
Back pain |
106/867 (12.23%) |
105/874 (12.01%) |
Muscle spasms |
53/867 (6.11%) |
101/874 (11.56%) |
Musculoskeletal pain |
45/867 (5.19%) |
43/874 (4.92%) |
Pain in extremity |
31/867 (3.58%) |
47/874 (5.38%) |
Nervous system disorders |
|
|
Dizziness |
81/867 (9.34%) |
62/874 (7.09%) |
Somnolence |
67/867 (7.73%) |
61/874 (6.98%) |
Psychiatric disorders |
|
|
Anxiety |
77/867 (8.88%) |
65/874 (7.44%) |
Depression |
106/867 (12.23%) |
100/874 (11.44%) |
Hallucination |
39/867 (4.50%) |
45/874 (5.15%) |
Insomnia |
101/867 (11.65%) |
96/874 (10.98%) |
Renal and urinary disorders |
|
|
Pollakiuria |
50/867 (5.77%) |
34/874 (3.89%) |
Proteinuria |
49/867 (5.65%) |
47/874 (5.38%) |
Vascular disorders |
|
|
Hypertension |
46/867 (5.31%) |
46/874 (5.26%) |