Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

• Sponsor: Alimera Sciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00490815
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Fluocinolone Acetonide; Drug: Fluocinolone Acetonide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Fluocinolone Acetonide; 0.5 mg fluocinolone acetonide intravitreal insert
Experimental: 2	Drug: Fluocinolone Acetonide; 0.2 mg fluocinolone acetonide intravitreal insert

Outcome Measures

Primary Outcome Measures

1. Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor [over 36 months]

   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.

Secondary Outcome Measures

1. Retinal Thickness [over 36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >= 18 years with diabetic macular edema

• Diagnosis of diabetes mellitus types 1 or 2

• Best corrected visual acuity of ≥ 19 letters

• Retinal thickness > 250 microns by OCT

• Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

• Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents

• Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy

• Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months

• Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months

• Any ocular surgery within the last 3 months

• Retinal laser treatment within the last 3 months

• History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy

• Any lens opacity which impairs visualization of the posterior pole

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Alimera Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alimera Sciences
• ClinicalTrials.gov Identifier: NCT00490815
• Other Study ID Numbers: C-01-06-002
• First Posted: Jun 25, 2007
• Last Update Posted: Feb 13, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Macular Edema; Edema; Fluocinolone Acetonide

Study Results

Participant Flow

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur Implant administered in one eye	Dose 0.5 ug/day Medidur Implant administered in one eye
Period Title: Overall Study
STARTED	20	17
COMPLETED	12	8
NOT COMPLETED	8	9

Baseline Characteristics

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant	Total
Arm/Group Description	Dose 0.2 ug/day Medidur Implant	Dose 0.5 ug/day Medidur Implant	Total of all reporting groups
Overall Participants	20	17	37
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 45%	7 41.2%	16 43.2%
>=65 years	11 55%	10 58.8%	21 56.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.6 (9.4)	67.4 (10.3)	66.9 (9.7)
Sex: Female, Male (Count of Participants)
Female	10 50%	6 35.3%	16 43.2%
Male	10 50%	11 64.7%	21 56.8%
Region of Enrollment (participants) [Number]
United States	20 100%	17 100%	37 100%

Outcome Measures

1. Primary Outcome

Title	Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
Description	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.
Time Frame	over 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur Implant	Dose 0.5 ug/day Medidur Implant
Measure Participants	12	8
Mean (Standard Deviation) [pg/ml]	1.4905 (1.87058)	0.7140 (0.78096)

2. Secondary Outcome

Title	Retinal Thickness
Time Frame	over 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant	Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur Implant	Dose 0.5 ug/day Medidur Implant
Measure Participants	20	17
Mean (Standard Deviation) [µg]	343.8 (142.92)	324.2 (136.86)

Adverse Events

Arm/Group Title	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
Arm/Group Description	Dose 0.2 ug/day Medidur Implant		Dose 0.5 ug/day Medidur Implant
All Cause Mortality
	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/20 (95%)		12/17 (70.6%)
Cardiac disorders
Acute myocardial infarction	0/20 (0%)	0	1/17 (5.9%)	1
Bradycardia	1/20 (5%)	1	0/17 (0%)	0
Cardiac failure congestive	0/20 (0%)	0	1/17 (5.9%)	1
Cardio-respiratory arrest	0/20 (0%)	0	2/17 (11.8%)	2
Coronary artery disease	0/20 (0%)	0	1/17 (5.9%)	1
Myocardial infarction	2/20 (10%)	2	1/17 (5.9%)	1
Myocardial ischaemia	1/20 (5%)	1	0/17 (0%)	0
Eye disorders
Glaucoma	1/20 (5%)	1	0/17 (0%)	0
Visual acuity reduced	0/20 (0%)	0	1/17 (5.9%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/20 (5%)	1	0/17 (0%)	0
Impaired gastric emptying	0/20 (0%)	0	1/17 (5.9%)	1
Small intestinal obstruction	1/20 (5%)	1	0/17 (0%)	0
General disorders
Chest pain	0/20 (0%)	0	1/17 (5.9%)	1
Hepatobiliary disorders
Gallbladder disorder	0/20 (0%)	0	1/17 (5.9%)	1
Infections and infestations
Appendicitis	1/20 (5%)	1	0/17 (0%)	0
Pneumonia	1/20 (5%)	1	1/17 (5.9%)	1
Urinary tract infection	1/20 (5%)	1	0/17 (0%)	0
Investigations
Blood glucose increased	1/20 (5%)	1	0/17 (0%)	0
Intraocular pressure increased	0/20 (0%)	0	2/17 (11.8%)	2
Metabolism and nutrition disorders
Hypoglycaemia	3/20 (15%)	6	0/17 (0%)	0
Nervous system disorders
Cerebrovascular accident	0/20 (0%)	0	1/17 (5.9%)	1
Haemorrhagic stroke	0/20 (0%)	0	1/17 (5.9%)	1
Presyncope	0/20 (0%)	0	1/17 (5.9%)	1
Syncope	1/20 (5%)	1	0/17 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/20 (0%)	0	1/17 (5.9%)	1
Pulmonary embolism	0/20 (0%)	0	1/17 (5.9%)	1
Skin and subcutaneous tissue disorders
Skin ulcer	1/20 (5%)	1	0/17 (0%)	0
Surgical and medical procedures
Cataract operation	13/20 (65%)	13	5/17 (29.4%)	5
Cataract operation	5/20 (25%)	5	4/17 (23.5%)	4
Cholecystectomy	0/20 (0%)	0	1/17 (5.9%)	1
Colectomy	1/20 (5%)	1	0/17 (0%)	0
Glaucoma surgery	0/20 (0%)	0	2/17 (11.8%)	2
Retinal operation	1/20 (5%)	1	0/17 (0%)	0
Retinal operation	1/20 (5%)	1	0/17 (0%)	0
Trabeculectomy	1/20 (5%)	1	2/17 (11.8%)	2
Vitrectomy	1/20 (5%)	1	0/17 (0%)	0
Vitrectomy	1/20 (5%)	1	0/17 (0%)	0
Vascular disorders
Deep vein thrombosis	0/20 (0%)	0	1/17 (5.9%)	1
Other (Not Including Serious) Adverse Events
	Fluocinolone Acetonide: 0.2 ug/Day Implant		Fluocinolone Acetonide: 0.5 ug/Day Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/20 (100%)		15/17 (88.2%)
Blood and lymphatic system disorders
Anaemia	1/20 (5%)	1	1/17 (5.9%)	1
Coagulopathy	0/20 (0%)	0	1/17 (5.9%)	1
Normochromic normocytic anaemia	1/20 (5%)	1	0/17 (0%)	0
Cardiac disorders
Aortic valve stenosis	1/20 (5%)	1	0/17 (0%)	0
Arrhythmia	1/20 (5%)	1	1/17 (5.9%)	1
Atrial fibrillation	1/20 (5%)	1	0/17 (0%)	0
Bradycardia	1/20 (5%)	1	1/17 (5.9%)	1
Cardiac failure congestive	1/20 (5%)	1	1/17 (5.9%)	1
Cardiac valve disease	1/20 (5%)	1	0/17 (0%)	0
Coronary artery disease	2/20 (10%)	2	0/17 (0%)	0
Left ventricular hypertrophy	1/20 (5%)	1	0/17 (0%)	0
Myocardial ischaemia	1/20 (5%)	1	0/17 (0%)	0
Sick sinus syndrome	1/20 (5%)	1	0/17 (0%)	0
Supraventricular tachycardia	0/20 (0%)	0	1/17 (5.9%)	1
Ear and labyrinth disorders
Deafness	0/20 (0%)	0	1/17 (5.9%)	2
Endocrine disorders
Hypothyroidism	1/20 (5%)	1	1/17 (5.9%)	1
Eye disorders
Asthenopia	1/20 (5%)	1	0/17 (0%)	0
Asthenopia	1/20 (5%)	1	0/17 (0%)	0
Cataract	11/20 (55%)	11	4/17 (23.5%)	4
Cataract	6/20 (30%)	6	4/17 (23.5%)	4
Cataract nuclear	0/20 (0%)	0	1/17 (5.9%)	1
Cataract subcapsular	1/20 (5%)	1	3/17 (17.6%)	4
Conjunctival haemorrhage	7/20 (35%)	8	7/17 (41.2%)	9
Conjunctival hyperaemia	0/20 (0%)	0	1/17 (5.9%)	1
Conjunctival hyperaemia	1/20 (5%)	1	0/17 (0%)	0
Corneal oedema	0/20 (0%)	0	1/17 (5.9%)	1
Diabetic retinal oedema	0/20 (0%)	0	1/17 (5.9%)	1
Diabetic retinopathy	0/20 (0%)	0	1/17 (5.9%)	1
Diplopia	0/20 (0%)	0	1/17 (5.9%)	1
Diplopia	0/20 (0%)	0	1/17 (5.9%)	1
Dry eye	1/20 (5%)	1	2/17 (11.8%)	2
Dry eye	1/20 (5%)	1	2/17 (11.8%)	2
Eye irritation	1/20 (5%)	3	2/17 (11.8%)	2
Eye irritation	1/20 (5%)	1	0/17 (0%)	0
Eye pain	4/20 (20%)	4	2/17 (11.8%)	5
Eye pain	3/20 (15%)	3	0/17 (0%)	0
Eye pruritus	2/20 (10%)	3	1/17 (5.9%)	1
Eye pruritus	1/20 (5%)	2	0/17 (0%)	0
Eyelid oedema	0/20 (0%)	0	1/17 (5.9%)	1
Foreign body sensation in eyes	2/20 (10%)	2	1/17 (5.9%)	1
Foreign body sensation in eyes	1/20 (5%)	1	0/17 (0%)	0
Glaucoma	1/20 (5%)	1	1/17 (5.9%)	2
Iris atrophy	0/20 (0%)	0	1/17 (5.9%)	1
Iris neovascularisation	1/20 (5%)	1	0/17 (0%)	0
Lacrimation increased	1/20 (5%)	1	1/17 (5.9%)	1
Lacrimation increased	1/20 (5%)	1	3/17 (17.6%)	3
Macular hole	1/20 (5%)	1	0/17 (0%)	0
Macular ischaemia	0/20 (0%)	0	1/17 (5.9%)	1
Maculopathy	4/20 (20%)	5	0/17 (0%)	0
Maculopathy	2/20 (10%)	2	1/17 (5.9%)	1
Myodesopsia	7/20 (35%)	10	6/17 (35.3%)	11
Myodesopsia	1/20 (5%)	1	1/17 (5.9%)	1
Ocular discomfort	0/20 (0%)	0	1/17 (5.9%)	1
Ocular hyperaemia	1/20 (5%)	1	2/17 (11.8%)	2
Optic atrophy	0/20 (0%)	0	1/17 (5.9%)	1
Optic atrophy	0/20 (0%)	0	1/17 (5.9%)	1
Photophobia	0/20 (0%)	0	1/17 (5.9%)	1
Photopsia	1/20 (5%)	1	1/17 (5.9%)	1
Posterior capsule opacification	2/20 (10%)	3	1/17 (5.9%)	1
Posterior capsule opacification	0/20 (0%)	0	1/17 (5.9%)	1
Retinal aneurysm	1/20 (5%)	1	0/17 (0%)	0
Retinal vascular occlusion	1/20 (5%)	1	0/17 (0%)	0
Vision blurred	1/20 (5%)	1	1/17 (5.9%)	1
Vision blurred	1/20 (5%)	1	0/17 (0%)	0
Visual impairment	0/20 (0%)	0	2/17 (11.8%)	2
Vitreous detachment	2/20 (10%)	2	1/17 (5.9%)	1
Vitreous haemorrhage	3/20 (15%)	3	1/17 (5.9%)	5
Gastrointestinal disorders
Colonic polyp	1/20 (5%)	1	0/17 (0%)	0
Constipation	0/20 (0%)	0	1/17 (5.9%)	1
Dental caries	0/20 (0%)	0	1/17 (5.9%)	1
Diarrhoea	1/20 (5%)	2	2/17 (11.8%)	2
Diverticulum	1/20 (5%)	1	0/17 (0%)	0
Duodenal ulcer	1/20 (5%)	1	0/17 (0%)	0
Dyspepsia	1/20 (5%)	1	0/17 (0%)	0
Food poisoning	0/20 (0%)	0	1/17 (5.9%)	1
Gastric ulcer	1/20 (5%)	1	0/17 (0%)	0
Gastrooesophageal reflux disease	1/20 (5%)	1	1/17 (5.9%)	1
Hiatus hernia	0/20 (0%)	0	1/17 (5.9%)	1
Intestinal mass	1/20 (5%)	1	0/17 (0%)	0
Nausea	0/20 (0%)	0	2/17 (11.8%)	2
Peptic ulcer	1/20 (5%)	1	0/17 (0%)	0
Toothache	1/20 (5%)	1	0/17 (0%)	0
Vomiting	0/20 (0%)	0	2/17 (11.8%)	2
General disorders
Chest discomfort	0/20 (0%)	0	1/17 (5.9%)	1
Chest pain	2/20 (10%)	2	0/17 (0%)	0
Fatigue	2/20 (10%)	2	1/17 (5.9%)	1
Oedema peripheral	0/20 (0%)	0	1/17 (5.9%)	1
Systemic inflammatory response syndrome	0/20 (0%)	0	1/17 (5.9%)	1
Hepatobiliary disorders
Cholelithiasis	0/20 (0%)	0	1/17 (5.9%)	1
Hepatic cirrhosis	1/20 (5%)	1	0/17 (0%)	0
Immune system disorders
Seasonal allergy	1/20 (5%)	1	1/17 (5.9%)	1
Infections and infestations
Blister infected	1/20 (5%)	1	0/17 (0%)	0
Cellulitis	0/20 (0%)	0	1/17 (5.9%)	1
Gastroenteritis viral	1/20 (5%)	1	0/17 (0%)	0
Gingival infection	1/20 (5%)	1	0/17 (0%)	0
Hordeolum	1/20 (5%)	2	0/17 (0%)	0
Hordeolum	1/20 (5%)	2	0/17 (0%)	0
Infected bites	1/20 (5%)	1	0/17 (0%)	0
Influenza	4/20 (20%)	4	1/17 (5.9%)	1
Laryngitis	1/20 (5%)	1	0/17 (0%)	0
Localised infection	0/20 (0%)	0	1/17 (5.9%)	1
Lower respiratory tract infection	0/20 (0%)	0	1/17 (5.9%)	1
Lung infection	1/20 (5%)	1	0/17 (0%)	0
Nasopharyngitis	0/20 (0%)	0	1/17 (5.9%)	1
Pneumonia	0/20 (0%)	0	2/17 (11.8%)	2
Sepsis	0/20 (0%)	0	1/17 (5.9%)	1
Sinusitis	0/20 (0%)	0	1/17 (5.9%)	1
Staphylococcal infection	1/20 (5%)	2	0/17 (0%)	0
Upper respiratory tract infection	0/20 (0%)	0	2/17 (11.8%)	2
Urinary tract infection	0/20 (0%)	0	1/17 (5.9%)	1
Injury, poisoning and procedural complications
Arthropod sting	1/20 (5%)	1	0/17 (0%)	0
Cataract operation complication	1/20 (5%)	1	0/17 (0%)	0
Contusion	1/20 (5%)	1	0/17 (0%)	0
Contusion	1/20 (5%)	1	2/17 (11.8%)	3
Fall	3/20 (15%)	5	2/17 (11.8%)	3
Joint sprain	0/20 (0%)	0	1/17 (5.9%)	1
Post procedural discomfort	1/20 (5%)	2	0/17 (0%)	0
Post-traumatic pain	0/20 (0%)	0	1/17 (5.9%)	1
Postoperative renal failure	1/20 (5%)	1	0/17 (0%)	0
Procedural complication	0/20 (0%)	0	1/17 (5.9%)	1
Rib fracture	0/20 (0%)	0	1/17 (5.9%)	1
Tendon rupture	0/20 (0%)	0	1/17 (5.9%)	1
Tibia fracture	0/20 (0%)	0	1/17 (5.9%)	1
Wrist fracture	1/20 (5%)	1	0/17 (0%)	0
Investigations
Blood cholesterol increased	1/20 (5%)	1	0/17 (0%)	0
Haematocrit decreased	1/20 (5%)	1	0/17 (0%)	0
Haemoglobin decreased	1/20 (5%)	1	0/17 (0%)	0
Intraocular pressure increased	4/20 (20%)	5	7/17 (41.2%)	12
Intraocular pressure increased	1/20 (5%)	1	0/17 (0%)	0
Optic nerve cup/disc ratio increased	1/20 (5%)	1	0/17 (0%)	0
Platelet count decreased	1/20 (5%)	1	0/17 (0%)	0
Red blood cell count decreased	1/20 (5%)	1	0/17 (0%)	0
White blood cell count increased	1/20 (5%)	1	0/17 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/20 (0%)	0	1/17 (5.9%)	1
Diabetes mellitus	1/20 (5%)	2	0/17 (0%)	0
Fluid retention	1/20 (5%)	1	0/17 (0%)	0
Hypercholesterolaemia	0/20 (0%)	0	2/17 (11.8%)	2
Hypoglycaemia	1/20 (5%)	1	0/17 (0%)	0
Obesity	1/20 (5%)	1	0/17 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/20 (10%)	2	1/17 (5.9%)	1
Back pain	1/20 (5%)	1	0/17 (0%)	0
Exostosis	1/20 (5%)	1	0/17 (0%)	0
Foot deformity	1/20 (5%)	2	0/17 (0%)	0
Groin pain	1/20 (5%)	1	0/17 (0%)	0
Joint swelling	1/20 (5%)	1	0/17 (0%)	0
Musculoskeletal pain	2/20 (10%)	3	2/17 (11.8%)	3
Myalgia	2/20 (10%)	2	0/17 (0%)	0
Osteoarthritis	1/20 (5%)	1	0/17 (0%)	0
Pain in extremity	1/20 (5%)	1	2/17 (11.8%)	2
Periarthritis	0/20 (0%)	0	1/17 (5.9%)	1
Tendonitis	1/20 (5%)	1	0/17 (0%)	0
Trigger finger	2/20 (10%)	3	0/17 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma	0/20 (0%)	0	1/17 (5.9%)	1
Basal cell carcinoma	0/20 (0%)	0	1/17 (5.9%)	1
Colon cancer	1/20 (5%)	1	0/17 (0%)	0
Skin cancer	0/20 (0%)	0	1/17 (5.9%)	1
Squamous cell carcinoma	0/20 (0%)	0	1/17 (5.9%)	1
Nervous system disorders
Amnesia	0/20 (0%)	0	1/17 (5.9%)	1
Cervicobrachial syndrome	0/20 (0%)	0	1/17 (5.9%)	1
Dizziness	1/20 (5%)	1	0/17 (0%)	0
Neuralgia	1/20 (5%)	1	0/17 (0%)	0
Neuropathy peripheral	2/20 (10%)	3	0/17 (0%)	0
Transient ischaemic attack	0/20 (0%)	0	1/17 (5.9%)	1
VIth nerve paralysis	0/20 (0%)	0	1/17 (5.9%)	1
Visual field defect	1/20 (5%)	1	0/17 (0%)	0
Psychiatric disorders
Anticipatory anxiety	0/20 (0%)	0	1/17 (5.9%)	3
Depression	1/20 (5%)	1	0/17 (0%)	0
Insomnia	1/20 (5%)	1	0/17 (0%)	0
Renal and urinary disorders
Nephrosclerosis	1/20 (5%)	1	0/17 (0%)	0
Renal failure chronic	1/20 (5%)	1	0/17 (0%)	0
Respiratory, thoracic and mediastinal disorders
Allergic respiratory symptom	1/20 (5%)	1	0/17 (0%)	0
Cough	2/20 (10%)	2	0/17 (0%)	0
Dyspnoea	1/20 (5%)	1	2/17 (11.8%)	3
Dyspnoea exertional	1/20 (5%)	1	0/17 (0%)	0
Haemoptysis	0/20 (0%)	0	1/17 (5.9%)	1
Hypoxia	0/20 (0%)	0	1/17 (5.9%)	1
Increased upper airway secretion	1/20 (5%)	1	0/17 (0%)	0
Oropharyngeal pain	1/20 (5%)	1	0/17 (0%)	0
Pneumothorax	0/20 (0%)	0	1/17 (5.9%)	1
Pulmonary hypertension	1/20 (5%)	1	0/17 (0%)	0
Pulmonary oedema	1/20 (5%)	1	1/17 (5.9%)	1
Rhinitis allergic	1/20 (5%)	1	0/17 (0%)	0
Rhinorrhoea	1/20 (5%)	1	0/17 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/20 (0%)	0	1/17 (5.9%)	1
Skin lesion	0/20 (0%)	0	1/17 (5.9%)	1
Skin ulcer	1/20 (5%)	1	0/17 (0%)	0
Vascular disorders
Deep vein thrombosis	0/20 (0%)	0	2/17 (11.8%)	2
Hypertension	1/20 (5%)	1	1/17 (5.9%)	1
Hypotension	0/20 (0%)	0	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.