Study: NCT02202551

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Acute colitis
Frequency: 1 affected / 60 at risk

Adverse event: Ostenecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Avascular necrosis of the right patella
Frequency: 1 affected / 60 at risk

Adverse event: Arthritis bacteria
Serious: yes
Organ System: Infections and infestations
Notes: Septic right knee requiring right total nee arthroplasty
Frequency: 1 affected / 60 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Non-St-Elevation mycardial infarction
Frequency: 1 affected / 60 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Supraventricular tachycardia
Frequency: 1 affected / 60 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Sigmoid, volvulus
Frequency: 1 affected / 60 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Worsening right knee degenerative disease
Frequency: 1 affected / 60 at risk

Adverse event: Intestinal pseudo-obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Oglive Syndrome
Frequency: 1 affected / 60 at risk

Adverse event: Clostridial sepsis
Serious: yes
Organ System: Infections and infestations
Notes: C. diff sepsis
Frequency: 1 affected / 60 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Left knee laceration
Frequency: 1 affected / 60 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Slow transit constipation
Frequency: 1 affected / 60 at risk

Adverse event: Psychiatric disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychosis
Frequency: 1 affected / 60 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Septic shock
Frequency: 1 affected / 60 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Encephalopathy
Frequency: 1 affected / 60 at risk

Adverse event: Lymphoadenopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Lymphoadenopathy
Frequency: 1 affected / 60 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Right distal radius fracture
Frequency: 1 affected / 60 at risk

Adverse event: Adenocarcinoma of the colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Adenocarcinoma of the ascending colon (right)
Frequency: 1 affected / 60 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Acute confusional syndrome
Frequency: 1 affected / 60 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Pseudomona aeruginosa sepsis
Frequency: 1 affected / 60 at risk

Adverse event: Neuroleptic malignant syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: Malignant neuroleptic syndrome
Frequency: 1 affected / 60 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Intestinal oclusion
Frequency: 1 affected / 60 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Ribs fracture
Frequency: 1 affected / 60 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 1 affected / 60 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Shoulder luxation
Frequency: 1 affected / 60 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac arrest
Frequency: 1 affected / 60 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 13 affected / 60 at risk

Adverse event: Hallucination (pooled)
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination (Pooled = combines all Preferred terms that contain the term "Hallucination."
Frequency: 15 affected / 60 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 60 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 10 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 60 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 60 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 60 at risk

Adverse event: On and off phenomenon
Serious: no
Organ System: Nervous system disorders
Notes: These events were worsening of disease over the duration of the study
Frequency: 7 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 60 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 60 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 3 affected / 60 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 60 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 60 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 60 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Acute confusional syndrome
Frequency: 1 affected / 78 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 1 affected / 78 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Shoulder luxation
Frequency: 1 affected / 78 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac arrest
Frequency: 1 affected / 78 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Comminuted intertrichanteric right hip fracture
Frequency: 1 affected / 78 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fractured right ankle
Frequency: 1 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Persistent urinary tract infection
Frequency: 1 affected / 78 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Rhabdomyolysis
Frequency: 1 affected / 78 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac chest pain (etiology unknown)
Frequency: 1 affected / 78 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Notes: Adverse drug reaction to melatonin and stool softner
Frequency: 1 affected / 78 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Heart attack
Frequency: 1 affected / 78 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Left hip fracture
Frequency: 1 affected / 78 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Left intertrochanteric femur fracture
Frequency: 1 affected / 78 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac arrhythmia
Frequency: 1 affected / 78 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Intestinal obstruction
Frequency: 1 affected / 78 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Attempted suicide
Frequency: 1 affected / 78 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory arrest
Frequency: 1 affected / 78 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Angina pectoris due to coronary vascular disease
Frequency: 1 affected / 78 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Notes: Paraesthesia
Frequency: 1 affected / 78 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Traumatic serial rib fractures
Frequency: 1 affected / 78 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hemothorax
Frequency: 1 affected / 78 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Acetabulum fracture right
Frequency: 1 affected / 78 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fractured pelvis
Frequency: 1 affected / 78 at risk

Adverse event: On and off phenomenon
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening motor fluctuations related to PD
Frequency: 1 affected / 78 at risk

Adverse event: Confusion postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Confusion after hip prothesis surgery
Frequency: 1 affected / 78 at risk

Adverse event: Restless legs syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening of restless leg syndrome
Frequency: 1 affected / 78 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain (obstipation)
Frequency: 1 affected / 78 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 29 affected / 78 at risk

Adverse event: Hallucination (pooled)
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination (Pooled = combines all Preferred terms that contain the term "Hallucination."
Frequency: 24 affected / 78 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 78 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 78 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 78 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 78 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 78 at risk

Adverse event: On and off phenomenon
Serious: no
Organ System: Nervous system disorders
Notes: These events were worsening of disease over the duration of the study
Frequency: 4 affected / 78 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 78 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 78 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 78 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 5 affected / 78 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 78 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 78 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 78 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Left wrist fracture
Frequency: 1 affected / 24 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia
Frequency: 1 affected / 24 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: MRSA bacteremia, presumably due to infected hardware
Frequency: 1 affected / 24 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory distress secondary to pneumonia
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Worsening of right knee pain
Frequency: 1 affected / 24 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Worsening benign prostatic hypertrophy
Frequency: 1 affected / 24 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis - right leg
Frequency: 1 affected / 24 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Notes: Altered mental status
Frequency: 1 affected / 24 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death due to natural causes
Frequency: 1 affected / 24 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 1 affected / 24 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 8 affected / 24 at risk

Adverse event: Hallucination (pooled)
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination (Pooled = combines all Preferred terms that contain the term "Hallucination."
Frequency: 5 affected / 24 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 24 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 24 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: On and off phenomenon
Serious: no
Organ System: Nervous system disorders
Notes: These events were worsening of disease over the duration of the study
Frequency: 4 affected / 24 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 1 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Sigmoid, volvulus
Frequency: 1 affected / 61 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 2 affected / 61 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Rhabdomyolysis
Frequency: 1 affected / 61 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 1 affected / 61 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Right tibial fracture - motor vehicle accident
Frequency: 1 affected / 61 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Notes: Altered mental state, confusion (occurred 30 days after the last dose)
Frequency: 1 affected / 61 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Broken ankle (left)
Frequency: 1 affected / 61 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Worsening anxiety
Frequency: 1 affected / 61 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Suicidal ideation with intent for self harm
Frequency: 1 affected / 61 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Dysfunction of deep brain stimulation device with increased disposition to fall
Frequency: 1 affected / 61 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Benign paroxysmal positional vertigo
Frequency: 1 affected / 61 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Craniocerebral injury
Frequency: 1 affected / 61 at risk

Adverse event: Hypokinesia
Serious: yes
Organ System: Nervous system disorders
Notes: Hypokinesis
Frequency: 1 affected / 61 at risk

Adverse event: Intercostal neuralgia
Serious: yes
Organ System: Nervous system disorders
Notes: Intercostal neuralgia
Frequency: 1 affected / 61 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Forearm fracture left
Frequency: 1 affected / 61 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: Hypertensive crisis
Frequency: 1 affected / 61 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Tongue swelling due to allergic reaction
Frequency: 1 affected / 61 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Thrombosis of the vena saphena magna in the thigh and lower leg left side
Frequency: 1 affected / 61 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Semi-myocardial infarction
Frequency: 1 affected / 61 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Notes: Parkinsonism aggravation
Frequency: 1 affected / 61 at risk

Adverse event: Hypertensive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Hypertensive cardiomyopathy
Frequency: 1 affected / 61 at risk

Adverse event: Gait inability
Serious: yes
Organ System: General disorders
Notes: Unable to walk
Frequency: 1 affected / 61 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Anterior myocardial infarction with acute pulmonary edema
Frequency: 1 affected / 61 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Left knee join effusion
Frequency: 1 affected / 61 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Notes: Acute psychiatric disorder (maniac manifestation)
Frequency: 1 affected / 61 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Notes: Worsening of dyskinesia (reassessment about alternative therapeutic)
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Epigastralgia
Frequency: 1 affected / 61 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fall
Frequency: 23 affected / 61 at risk

Adverse event: Hallucination (pooled)
Serious: no
Organ System: Psychiatric disorders
Notes: Hallucination (Pooled = combines all Preferred terms that contain the term "Hallucination."
Frequency: 10 affected / 61 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 61 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 12 affected / 61 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 61 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 61 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 61 at risk

Adverse event: On and off phenomenon
Serious: no
Organ System: Nervous system disorders
Notes: These events were worsening of disease over the duration of the study
Frequency: 3 affected / 61 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 61 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 61 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Notes: Worsening of Parkinson's disease
Frequency: 6 affected / 61 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 61 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk