Study: NCT03062449

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: chest pain
Frequency: 1 affected / 16 at risk

Adverse event: Movement disorder
Serious: no
Organ System: Nervous system disorders
Notes: abnormal movement
Frequency: 1 affected / 16 at risk

Adverse event: skin lesion or rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 4 affected / 16 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Notes: sleep disruption
Frequency: 3 affected / 16 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: weight gain
Frequency: 3 affected / 16 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Eye disorders
Notes: surgery
Frequency: 2 affected / 16 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: syncope
Frequency: 1 affected / 16 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: bradycardia
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea
Frequency: 5 affected / 16 at risk

Adverse event: cognitive decline
Serious: no
Organ System: Nervous system disorders
Notes: cognitive decline
Frequency: 3 affected / 16 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: weight loss
Frequency: 2 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: anxiety
Frequency: 1 affected / 16 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 1 affected / 16 at risk

Adverse event: tic bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 2 affected / 16 at risk

Adverse event: potential overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: over dose
Frequency: 1 affected / 16 at risk

Adverse event: atrophy of hands
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: atrophy
Frequency: 1 affected / 16 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Notes: edema
Frequency: 1 affected / 16 at risk

Adverse event: taste change
Serious: no
Organ System: Nervous system disorders
Notes: taste change
Frequency: 1 affected / 16 at risk

Adverse event: reduced appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: reduced appetite
Frequency: 2 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea
Frequency: 1 affected / 16 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: gas
Frequency: 1 affected / 16 at risk

Adverse event: Change of bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Notes: change in bowel habits
Frequency: 1 affected / 16 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: hiccups
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 1 affected / 16 at risk

Adverse event: worsening vision secondary to left cataract
Serious: no
Organ System: Eye disorders
Notes: visual decline
Frequency: 1 affected / 16 at risk

Adverse event: dental procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: procedure
Frequency: 1 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: cold
Frequency: 1 affected / 16 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: agitation
Frequency: 2 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: lightheadedness
Frequency: 1 affected / 16 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: nasal congestion
Frequency: 2 affected / 16 at risk

Adverse event: flashing lights at night
Serious: no
Organ System: Eye disorders
Notes: flashing lights
Frequency: 1 affected / 16 at risk

Adverse event: feeling sped up
Serious: no
Organ System: Psychiatric disorders
Notes: anxiety
Frequency: 1 affected / 16 at risk

Adverse event: right ear infection
Serious: no
Organ System: Infections and infestations
Notes: infection
Frequency: 1 affected / 16 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: arthritis
Frequency: 1 affected / 16 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: gastroenteritis
Frequency: 2 affected / 13 at risk

Adverse event: Movement disorder
Serious: no
Organ System: Nervous system disorders
Notes: abnormal movement
Frequency: 1 affected / 13 at risk

Adverse event: skin lesion or rash
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 1 affected / 13 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: weight gain
Frequency: 3 affected / 13 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Eye disorders
Notes: surgery
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea
Frequency: 2 affected / 13 at risk

Adverse event: cognitive decline
Serious: no
Organ System: Nervous system disorders
Notes: cognitive decline
Frequency: 7 affected / 13 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: weight loss
Frequency: 2 affected / 13 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: anxiety
Frequency: 1 affected / 13 at risk

Adverse event: tic bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: pneumonia
Frequency: 1 affected / 13 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Vascular disorders
Notes: edema
Frequency: 1 affected / 13 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Vascular disorders
Notes: vascular congestion
Frequency: 1 affected / 13 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: cellulitis
Frequency: 2 affected / 13 at risk

Adverse event: recurrent major depressive disorder
Serious: no
Organ System: Psychiatric disorders
Notes: depression
Frequency: 1 affected / 13 at risk

Adverse event: reduced appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: reduced appetite
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea
Frequency: 1 affected / 13 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: gas
Frequency: 2 affected / 13 at risk

Adverse event: reduced platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: reduced platelets
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: URI
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: fatigue
Frequency: 1 affected / 13 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: neuropathy
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: abdominal pain
Frequency: 1 affected / 13 at risk

Adverse event: blood pressure elevation
Serious: no
Organ System: Vascular disorders
Notes: hypertension
Frequency: 1 affected / 13 at risk

Adverse event: focal pain above left breast
Serious: no
Organ System: Reproductive system and breast disorders
Notes: pain
Frequency: 1 affected / 13 at risk

Adverse event: right hearing impairment
Serious: no
Organ System: Ear and labyrinth disorders
Notes: hearing loss
Frequency: 1 affected / 13 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: hypothyroidism
Frequency: 1 affected / 13 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: hyperlipidemia
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: cold
Frequency: 1 affected / 13 at risk

Adverse event: puncture wound left foot
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 1 affected / 13 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Notes: agitation
Frequency: 2 affected / 13 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: gout
Frequency: 1 affected / 13 at risk

Adverse event: Apathy
Serious: no
Organ System: Psychiatric disorders
Notes: lack of motivation
Frequency: 1 affected / 13 at risk

Adverse event: soft tissue injury due to fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: injury
Frequency: 1 affected / 13 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: arthritis
Frequency: 1 affected / 13 at risk

Adverse event: increased restlessness
Serious: no
Organ System: Psychiatric disorders
Notes: agitation
Frequency: 1 affected / 13 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Notes: hot flashes
Frequency: 1 affected / 13 at risk

Adverse event: falls, no injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: falls
Frequency: 1 affected / 13 at risk