Trial Outcomes & Findings for To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca (NCT NCT01900249)
NCT ID: NCT01900249
Last Updated: 2016-10-03
Results Overview
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
204 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2016-10-03
Participant Flow
Participant milestones
| Measure |
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
|
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
|
Placebo
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
68
|
69
|
|
Overall Study
COMPLETED
|
64
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Baseline characteristics by cohort
| Measure |
R348 Ophthalmic Solution, 0.2%
n=67 Participants
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
|
R348 Ophthalmic Solution, 0.5%
n=68 Participants
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
|
Placebo
n=69 Participants
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 11.59 • n=99 Participants
|
63.3 Years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
61.5 Years
STANDARD_DEVIATION 15.2 • n=206 Participants
|
62.4 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
162 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
Outcome measures
| Measure |
R348 Ophthalmic Solution, 0.2%
n=67 Participants
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
|
R348 Ophthalmic Solution, 0.5%
n=68 Participants
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
|
Placebo
n=69 Participants
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
|
|---|---|---|---|
|
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
|
-1.00 units on a scale (Likert)
Interval -3.0 to 1.0
|
-0.78 units on a scale (Likert)
Interval -2.5 to 1.0
|
-0.78 units on a scale (Likert)
Interval -2.5 to 1.0
|
Adverse Events
R348 Ophthalmic Solution, 0.2%
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
R348 Ophthalmic Solution, 0.5%
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R348 Ophthalmic Solution, 0.2%
n=67 participants at risk
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
|
R348 Ophthalmic Solution, 0.5%
n=68 participants at risk
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
|
Placebo
n=69 participants at risk
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Malignant hyperthermia
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Chest pain
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
Other adverse events
| Measure |
R348 Ophthalmic Solution, 0.2%
n=67 participants at risk
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
|
R348 Ophthalmic Solution, 0.5%
n=68 participants at risk
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
|
Placebo
n=69 participants at risk
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Cardiac disorders
Sinus Tachycardia
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Eye Discharge
|
4.5%
3/67 • Number of events 3 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
4.4%
3/68 • Number of events 3 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/68 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Blepharitis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Chalazion
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Meibomianitis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Ocular Hyperaemia
|
4.5%
3/67 • Number of events 3 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Conjunctival Cyst
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Conjunctival Disorder
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Conjunctivitis Allergic
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Eye Pain
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Punctate Keratitis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Trichiasis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 3 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Corneal Abrasion
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Keratitis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Eye disorders
Photophobia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/68 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Salivary Duct Obstruction
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Instillation Site Pain
|
25.4%
17/67 • Number of events 20 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
51.5%
35/68 • Number of events 37 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
4.3%
3/69 • Number of events 3 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Instillation Site Pruritus
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
5.9%
4/68 • Number of events 4 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Chest Pain
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Fatigue
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
instillation Site Paraesthesia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Instillation Site Discomfort
|
6.0%
4/67 • Number of events 5 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
General disorders
Hyperthermia Malignant
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Immune system disorders
Hypersensitivity
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Urinary Track Infection
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/68 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Influenza
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/68 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
2/67 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Hordeolum
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Kidney Infection
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Pharyngitis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Sinusitis Bacterial
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Cystitis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Investigations
Urine Analysis Abnormal
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Investigations
Manifest Refraction
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protusion
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/68 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Psychiatric disorders
Depression
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/69 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.4%
1/69 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/67 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
1.5%
1/68 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Surgical and medical procedures
Rotator Cuff Repair
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/68 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Number of events 1 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
2.9%
2/68 • Number of events 2 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
0.00%
0/69 • The AE reporting period begins with the first dose of double blind study drug and ends with the final study (Day 91) visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60