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This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide | Drug | 0.5 mg fluocinolone acetonide intravitreal insert |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data. | over 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Thickness | over 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluocinolone Acetonide: 0.2 ug/Day Implant | Dose 0.2 ug/day Medidur Implant administered in one eye |
| FG001 | Fluocinolone Acetonide: 0.5 ug/Day Implant | Dose 0.5 ug/day Medidur Implant administered in one eye |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluocinolone Acetonide: 0.2 ug/Day Implant | Dose 0.2 ug/day Medidur Implant |
| BG001 | Fluocinolone Acetonide: 0.5 ug/Day Implant | Dose 0.5 ug/day Medidur Implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor | This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data. | Posted | Mean | Standard Deviation | pg/ml | over 36 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluocinolone Acetonide: 0.2 ug/Day Implant | Dose 0.2 ug/day Medidur Implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Billman, Senior Director of Scientific Affairs | Alimera Sciences, Inc | 678-527-1302 | kathleen.billman@alimerasciences.com |
Not provided
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Fluocinolone Acetonide |
| Drug |
0.2 mg fluocinolone acetonide intravitreal insert |
|
| Lost to Follow-up |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Retinal Thickness | Posted | Mean | Standard Deviation | µg | over 36 months |
|
|
|
| 19 |
| 20 |
| 20 |
| 20 |
| EG001 | Fluocinolone Acetonide: 0.5 ug/Day Implant | Dose 0.5 ug/day Medidur Implant | 12 | 17 | 15 | 17 |
| Bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Visual acuity reduced | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment | #Study eye |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Study eye |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Colectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Glaucoma surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Study eye |
|
| Retinal operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Study eye |
|
| Retinal operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Trabeculectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Study eye |
|
| Vitrectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Study eye |
|
| Vitrectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac valve disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Asthenopia | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Cataract nuclear | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Cataract subcapsular | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Corneal oedema | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Diabetic retinal oedema | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Diabetic retinopathy | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Diplopia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Diplopia | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Eye irritation | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Eye irritation | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Eye pruritus | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Eye pruritus | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Eyelid oedema | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Iris atrophy | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Iris neovascularisation | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Macular hole | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Macular ischaemia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Maculopathy | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Maculopathy | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Myodesopsia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Myodesopsia | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Ocular discomfort | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Ocular hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Optic atrophy | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Optic atrophy | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Photophobia | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Photopsia | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Posterior capsule opacification | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Posterior capsule opacification | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Retinal aneurysm | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Retinal vascular occlusion | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Vision blurred | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Visual impairment | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Vitreous detachment | Eye disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Vitreous haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Intestinal mass | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Blister infected | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA | Non-systematic Assessment | #Study eye |
|
| Hordeolum | Infections and infestations | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Infected bites | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | #Study eye |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | #Study eye |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Postoperative renal failure | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment | #Study eye |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment | #Study eye |
|
| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment | #Fellow eye |
|
| Optic nerve cup/disc ratio increased | Investigations | MedDRA | Non-systematic Assessment | #Study eye |
|
| Platelet count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| VIth nerve paralysis | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Anticipatory anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Nephrosclerosis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Allergic respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment | #Study eye |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |