Study: NCT02748512

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Factitious disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Pancreatic cyst
Serious: no
Organ System: Gastrointestinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 2 affected / 14 at risk

Adverse event: Pituitary-dependent Cushing's syndrome
Serious: no
Organ System: Endocrine disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 2 affected / 14 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 14 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 14 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Meibomianitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 14 at risk

Adverse event: Vitreous haze
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 14 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 14 at risk

Adverse event: Factitious disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 2 affected / 12 at risk

Adverse event: Pituitary-dependent Cushing's syndrome
Serious: no
Organ System: Endocrine disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: By-treatment counts were per treated eye and a subject could be included more than once. Total subject counts were per subject and a subject was included only once even if the subject had both eyes treated.
Frequency: 1 affected / 12 at risk

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

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

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

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

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

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

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

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 12 at risk

Adverse event: Device failure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 12 at risk

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