Study: NCT01982435

Adverse event: Worsening of Chronic Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: POSSIBLE CELLULITIS TO RIGHT LOWER EXTREMITY
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: ACUTE INFARCT STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: UNSTABLE ANGINA AND CHEST PAIN
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: LARGE OVARIAN NEOPLASM
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZED FOR PERITONITIS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZED FOR ANGINA/SOB
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZED FOR DIABETIC RIGHT HEEL ULCER
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZED FORCONFUSION/SLURRED SPEECH AFTER FALL
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZED FOR RECURRENT SOB, LEG EDEMA
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZATION FOR GANGRENE
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZATION R DIABETIC FOOT ULCER INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZATION FOR GANGRENE/AMPUTATION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: HOSPITALIZATION FOR OSTEOMYELITIS/AMPUTATION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Decreased Vision
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 15 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 15 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Difficulty with reading
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 15 at risk

Adverse event: Difficulty with driving
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 15 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain from fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 15 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Thyroid cancer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Uterine cancer suspect
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Bladder cancer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypovitaminosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Ocular irritation
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 15 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Generalized weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Anaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Benign polyps
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 15 at risk

Adverse event: Thalassaemia minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Optic neuropathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Elevated d-Dimer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Thyroid mass
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 15 at risk

Adverse event: OSA Worsening
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening of cataracts
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Cold Sore
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Glare in vision
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Bullous eruption on glans
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus on neck
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Medicamentosa suspect
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Chronic angle closure glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lower extremity sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 15 at risk

Adverse event: Tingling sensation in feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Wound
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Elevated Heart Rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Elevated FBS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Staph infection of wound on ankle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Difficulty with watching television
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Addison's Disease worsening
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Worsening of trigger finger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Elevated TSH levels
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vertigo
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: HOSPITALIZATION FOR TOTAL HYSTERECTOMY
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: HOSPITALIZATION FOR HYPERKALEMIA
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Decreased Vision
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 12 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Difficulty with reading
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 12 at risk

Adverse event: Difficulty with driving
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Hyperglycemic episode
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Foreign Body Sensation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Pain from fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 12 at risk

Adverse event: Hypovitaminosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Elevated microalbumin
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ocular irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Optic neuropathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Elevated Creatinine levels
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sun damage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Elevated INR
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus after fluorescein dye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Asymptomatic Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Insomnia - worsening
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ocular swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Difficulty with watching television
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: SOB episode - allergy to Zanaflex
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk