Trial Outcomes & Findings for Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study (NCT NCT01304706)
NCT ID: NCT01304706
Last Updated: 2015-05-04
Results Overview
This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
12 months
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
Fluocinolone Acetonide
Fluocinolone Acetonide: 0.2 μg/day
|
|---|---|
|
Overall Study
STARTED
|
121
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Fluocinolone Acetonide
Fluocinolone Acetonide: 0.2 μg/day
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Discontinued due to failed drug admin.
|
1
|
Baseline Characteristics
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
Baseline characteristics by cohort
| Measure |
Fluocinolone Acetonide
n=120 Participants
Fluocinolone Acetonide: 0.2 μg/day
|
|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
|
Age, Customized
<35
|
0 participants
n=5 Participants
|
|
Age, Customized
35-44
|
3 participants
n=5 Participants
|
|
Age, Customized
45-54
|
14 participants
n=5 Participants
|
|
Age, Customized
55-64
|
42 participants
n=5 Participants
|
|
Age, Customized
65-74
|
43 participants
n=5 Participants
|
|
Age, Customized
75-84
|
17 participants
n=5 Participants
|
|
Age, Customized
>=85
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThis is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
Outcome measures
| Measure |
Fluocinolone Acetonide
n=120 Participants
Fluocinolone Acetonide: 0.2 μg/day
|
|---|---|
|
Number of Participants With Adverse Events
Serious Adverse Event
|
42 participants
|
|
Number of Participants With Adverse Events
Adverse Event
|
100 participants
|
Adverse Events
Fluocinolone Acetonide
Serious events: 42 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluocinolone Acetonide
n=120 participants at risk
Fluocinolone Acetonide: 0.2 μg/day
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.7%
2/120 • Number of events 2
|
|
Cardiac disorders
Bradycardia
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
2/120 • Number of events 2
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
3.3%
4/120 • Number of events 4
|
|
Cardiac disorders
Myocardial infarction
|
4.2%
5/120 • Number of events 5
|
|
Eye disorders
Ocular hypertension
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Vitreous haemorrhage
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.83%
1/120 • Number of events 1
|
|
General disorders
Chest pain
|
1.7%
2/120 • Number of events 2
|
|
General disorders
Generalised oedema
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Intraocular pressure increased
|
2.5%
3/120 • Number of events 4
|
|
Metabolism and nutrition disorders
Gout
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.83%
1/120 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.83%
1/120 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.83%
1/120 • Number of events 1
|
|
Renal and urinary disorders
Renal failure chronic
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.83%
1/120 • Number of events 1
|
|
Surgical and medical procedures
Cataract operation
|
4.2%
5/120 • Number of events 5
|
|
Surgical and medical procedures
Colostomy
|
0.83%
1/120 • Number of events 1
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.83%
1/120 • Number of events 1
|
|
Surgical and medical procedures
Surgery
|
0.83%
1/120 • Number of events 1
|
|
Surgical and medical procedures
Trabeculectomy
|
0.83%
1/120 • Number of events 1
|
|
Surgical and medical procedures
Trabeculoplasty
|
0.83%
1/120 • Number of events 1
|
|
Surgical and medical procedures
Vitrectomy
|
4.2%
5/120 • Number of events 5
|
|
Vascular disorders
Hypertension
|
1.7%
2/120 • Number of events 2
|
Other adverse events
| Measure |
Fluocinolone Acetonide
n=120 participants at risk
Fluocinolone Acetonide: 0.2 μg/day
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
6/120 • Number of events 6
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Angina unstable
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Cardiomegaly
|
1.7%
2/120 • Number of events 2
|
|
Cardiac disorders
Coronary artery disease
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.83%
1/120 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.83%
1/120 • Number of events 1
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.83%
1/120 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
1.7%
2/120 • Number of events 2
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.83%
1/120 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
3.3%
4/120 • Number of events 5
|
|
Eye disorders
Altered visual depth perception
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Blepharitis
|
2.5%
3/120 • Number of events 3
|
|
Eye disorders
Borderline glaucoma
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Cataract
|
7.5%
9/120 • Number of events 10
|
|
Eye disorders
Cataract cortical
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Cataract nuclear
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Cataract subcapsular
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Conjunctival haemorrhage
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Conjunctival hyperaemia
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Corneal striae
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Deposit eye
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Diabetic retinal oedema
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Diplopia
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Dry eye
|
2.5%
3/120 • Number of events 3
|
|
Eye disorders
Erythema of eyelid
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Eye discharge
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Eye haemorrhage
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Eye irritation
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Eye pain
|
9.2%
11/120 • Number of events 13
|
|
Eye disorders
Eye pruritus
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Eyelid cyst
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Eyelid ptosis
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Eyelids pruritus
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Foreign body sensation in eyes
|
0.83%
1/120 • Number of events 2
|
|
Eye disorders
Glaucoma
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Halo vision
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Iris neovascularisation
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Macular degeneration
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Macular hole
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Macular oedema
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Maculopathy
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Metamorphopsia
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Myodesopsia
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Ocular discomfort
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
4.2%
5/120 • Number of events 5
|
|
Eye disorders
Ocular hypertension
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Open angle glaucoma
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Papilloedema
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Photophobia
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Photopsia
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Posterior capsule opacification
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Retinal depigmentation
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Retinal exudates
|
2.5%
3/120 • Number of events 3
|
|
Eye disorders
Retinal haemorrhage
|
2.5%
3/120 • Number of events 3
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.5%
3/120 • Number of events 4
|
|
Eye disorders
Visual acuity reduced
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Visual impairment
|
1.7%
2/120 • Number of events 2
|
|
Eye disorders
Vitreous detachment
|
0.83%
1/120 • Number of events 1
|
|
Eye disorders
Vitreous haemorrhage
|
4.2%
5/120 • Number of events 7
|
|
Eye disorders
Vitritis
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
2/120 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.3%
4/120 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.5%
3/120 • Number of events 3
|
|
Gastrointestinal disorders
Gingival disorder
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.5%
3/120 • Number of events 3
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.83%
1/120 • Number of events 1
|
|
Gastrointestinal disorders
Proctalgia
|
0.83%
1/120 • Number of events 1
|
|
General disorders
Fatigue
|
1.7%
2/120 • Number of events 2
|
|
General disorders
Generalised oedema
|
0.83%
1/120 • Number of events 1
|
|
General disorders
Malaise
|
0.83%
1/120 • Number of events 1
|
|
General disorders
Pain
|
1.7%
2/120 • Number of events 2
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.83%
1/120 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
1.7%
2/120 • Number of events 2
|
|
Immune system disorders
Seasonal allergy
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Abdominal abscess
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.7%
2/120 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Gastritis viral
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
2.5%
3/120 • Number of events 3
|
|
Infections and infestations
Genital infection fungal
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Histoplasmosis
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Infected cyst
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.7%
2/120 • Number of events 2
|
|
Infections and infestations
Localised infection
|
1.7%
2/120 • Number of events 2
|
|
Infections and infestations
Osteomyelitis
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
3.3%
4/120 • Number of events 5
|
|
Infections and infestations
Tooth abscess
|
0.83%
1/120 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
6/120 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
5.8%
7/120 • Number of events 8
|
|
Infections and infestations
Vaginal infection
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.2%
5/120 • Number of events 5
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.83%
1/120 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Blood cholesterol increased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Blood magnesium decreased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Intraocular pressure increased
|
2.5%
3/120 • Number of events 3
|
|
Investigations
Intraocular pressure test abnormal
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Platelet count increased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Red blood cell count decreased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
Very low density lipoprotein increased
|
0.83%
1/120 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
1.7%
2/120 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
2/120 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.83%
1/120 • Number of events 1
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
3/120 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
5/120 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Head deformity
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.5%
3/120 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
3/120 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.83%
1/120 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.7%
2/120 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.83%
1/120 • Number of events 3
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.83%
1/120 • Number of events 2
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Demyelination
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.7%
2/120 • Number of events 2
|
|
Nervous system disorders
Encephalopathy
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Grand mal convulsion
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Headache
|
3.3%
4/120 • Number of events 4
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
2/120 • Number of events 2
|
|
Nervous system disorders
Neuritis
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
2.5%
3/120 • Number of events 3
|
|
Nervous system disorders
Presyncope
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Sciatica
|
0.83%
1/120 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
1.7%
2/120 • Number of events 2
|
|
Nervous system disorders
VIth nerve paralysis
|
0.83%
1/120 • Number of events 1
|
|
Nervous system disorders
Visual field defect
|
0.83%
1/120 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.7%
2/120 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
0.83%
1/120 • Number of events 1
|
|
Psychiatric disorders
Panic attack
|
0.83%
1/120 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.83%
1/120 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
2.5%
3/120 • Number of events 3
|
|
Renal and urinary disorders
Renal failure chronic
|
3.3%
4/120 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
4/120 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
5/120 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.83%
1/120 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.7%
2/120 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Cutis laxa
|
0.83%
1/120 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.83%
1/120 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.83%
1/120 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.83%
1/120 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.83%
1/120 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.83%
1/120 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.83%
1/120 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.83%
1/120 • Number of events 1
|
|
Vascular disorders
Arterial stenosis limb
|
0.83%
1/120 • Number of events 1
|
|
Vascular disorders
Arteriosclerosis
|
0.83%
1/120 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.3%
4/120 • Number of events 5
|
|
Vascular disorders
Hypotension
|
0.83%
1/120 • Number of events 1
|
|
Vascular disorders
Leriche syndrome
|
0.83%
1/120 • Number of events 1
|
Additional Information
Kathleen Billman, Senior Director, Scientific Affairs
Alimera Sciences, Inc.
Phone: 678-527-1302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60