Study: NCT02346201

Adverse event: Hospitalization/ER visit for confusion/weakness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 99 at risk

Adverse event: Hospitalization/ER visit for planned surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 99 at risk

Adverse event: Hospitalization/ER visit for UTI/other infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 99 at risk

Adverse event: Hospitalization/ER visit for congestive heart failure or exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for weakness/fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for upper arm and chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for Bradycardia/nausea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for gait impairment and transient visual loss
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hospitalization/ER visit for syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 99 at risk

Adverse event: aggressive behavior or hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 99 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 99 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 99 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 99 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 99 at risk

Adverse event: anxiety, nervousness, or tension
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 99 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 99 at risk

Adverse event: blood pressure changes
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 99 at risk

Adverse event: blurry vision or eyesight changes
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 99 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 99 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 35 affected / 99 at risk

Adverse event: Distractibility
Serious: no
Organ System: Social circumstances
Frequency: 42 affected / 99 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 99 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 43 affected / 99 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 99 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 99 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 99 at risk

Adverse event: Alopecia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 99 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 99 at risk

Adverse event: impaired learning
Serious: no
Organ System: Social circumstances
Frequency: 32 affected / 99 at risk

Adverse event: impulsivity
Serious: no
Organ System: Social circumstances
Frequency: 12 affected / 99 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 99 at risk

Adverse event: libido changes
Serious: no
Organ System: General disorders
Frequency: 6 affected / 99 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 99 at risk

Adverse event: numbness of fingers, toes, nose, ears, lips
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 99 at risk

Adverse event: muscle stiffness or aching, muscle tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 99 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 99 at risk

Adverse event: skin rash, redness, or inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 99 at risk

Adverse event: tachycardia (increased heart rate)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 99 at risk

Adverse event: urine color changes
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 99 at risk

Adverse event: urine output, decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 99 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 99 at risk

Adverse event: cough/congestion/bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 99 at risk

Adverse event: falls with/without bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 99 at risk

Adverse event: fluid retention/swollen feet
Serious: no
Organ System: General disorders
Frequency: 5 affected / 99 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 99 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Lost more than 7% of baseline body weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 99 at risk

Adverse event: Hospitalization/ER visit for confusion/weakness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for UTI/other infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Hospitalization/ER visit for Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for congestive heart failure or exacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for peripheral blood clots
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for facial drooping
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for multiple seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hospitalization/ER visit for abdominal pain and constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 101 at risk

Adverse event: aggressive behavior or hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 101 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 101 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 101 at risk

Adverse event: anxiety, nervousness, or tension
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 101 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 101 at risk

Adverse event: blood pressure changes
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 101 at risk

Adverse event: blurry vision or eyesight changes
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 101 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 101 at risk

Adverse event: Distractibility
Serious: no
Organ System: Social circumstances
Frequency: 35 affected / 101 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 20 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 44 affected / 101 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 101 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 101 at risk

Adverse event: Alopecia
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 101 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 101 at risk

Adverse event: impaired learning
Serious: no
Organ System: Social circumstances
Frequency: 30 affected / 101 at risk

Adverse event: impulsivity
Serious: no
Organ System: Social circumstances
Frequency: 21 affected / 101 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 101 at risk

Adverse event: libido changes
Serious: no
Organ System: General disorders
Frequency: 8 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 101 at risk

Adverse event: numbness of fingers, toes, nose, ears, lips
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 101 at risk

Adverse event: muscle stiffness or aching, muscle tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 101 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 101 at risk

Adverse event: skin rash, redness, or inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 101 at risk

Adverse event: tachycardia (increased heart rate)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 101 at risk

Adverse event: urine color changes
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 101 at risk

Adverse event: urine output, decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 101 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 101 at risk

Adverse event: cough/congestion/bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: falls with/without bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 101 at risk

Adverse event: Feeling cold
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 101 at risk

Adverse event: fluid retention/swollen feet
Serious: no
Organ System: General disorders
Frequency: 3 affected / 101 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 5 affected / 101 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Lost more than 7% of baseline body weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 101 at risk