Study: NCT00998010

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Notes: varicella-zoster virus (VZV) Infection
Frequency: 1 affected / 24 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: Ventriculoperitoneal (VP) Shunt placement
Frequency: 1 affected / 24 at risk

Adverse event: Craniotomy
Serious: yes
Organ System: Nervous system disorders
Notes: Craniotomy due to PD
Frequency: 1 affected / 24 at risk

Adverse event: Pullmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hydrocephalus placement
Frequency: 1 affected / 24 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 24 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 24 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 24 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 24 at risk

Adverse event: Encephalopathy (elevated ammonia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vasogenic edema
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

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

Adverse event: Hypersomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

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

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: skin rash-Radiodermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 24 at risk

Adverse event: Skin rash- diffuse
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Wound complication
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 24 at risk

Adverse event: Other-Blepharitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: other- Skin Tears L. Forearm L. Peritibial region
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: skin rash-Periorbital
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: skin rash (bactrim allergy)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Skin Rash/acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: bruising Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cushingoid appearance
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 24 at risk

Adverse event: Ocular/ chalazion
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Ocular/visual Xerophtalmia/dry eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Ocular/visual Blurred vision
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 24 at risk

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

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Bloating/Hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cardiac/general Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cardiac/general Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cardiac arrhythmia Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Allergy/immunology Allergic rhinitis (nasal congestion )
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Other-Pelvic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Ear Infection/otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 24 at risk

Adverse event: Stye on LL conjunctival border
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Other-Herpes zoster infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Lymphatics Limb edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Lymphatics/edema Swelling on the lips
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 24 at risk

Adverse event: Elevated ALP
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 24 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 24 at risk

Adverse event: Elevated LDH
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperglicemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated CREATINIE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decrease GFR
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Elevated triglycerides
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

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

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

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

Adverse event: Gait/Walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 24 at risk

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

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 24 at risk

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

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Motor weakness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Falls
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness postural
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: voice changes Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Alexia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Apathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Difficulty with concentration
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: extrapyramidal involuntary Movement Restless legs
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: other- Abulia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Bursitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dental: periodontal disease-sensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 24 at risk

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

Adverse event: Other-VZV infection related pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cramping/Bilateral Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Nose
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Dispnea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: other-Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 24 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 24 at risk