Trial Outcomes & Findings for Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2) (NCT NCT02040623)
NCT ID: NCT02040623
Last Updated: 2016-10-10
Results Overview
Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2016-10-10
Participant Flow
Participant milestones
| Measure |
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
|
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
|
Placebo
Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
Baseline characteristics by cohort
| Measure |
R348 Ophthalmic Solution, 0.2%
n=11 Participants
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
|
R348 Ophthalmic Solution, 0.5%
n=12 Participants
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
|
Placebo
n=12 Participants
Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 17.15 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 15.96 • n=5 Participants
|
55.13 years
STANDARD_DEVIATION 10.81 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: The per-protocol (PP) population excludes subjects with significant protocol deviations or with early study termination
Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.
Outcome measures
| Measure |
R348 Ophthalmic Solution, 0.2%
n=7 Participants
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
|
R348 Ophthalmic Solution, 0.5%
n=6 Participants
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
|
Placebo
n=9 Participants
Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day
|
|---|---|---|---|
|
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
|
-4.2 units on a scale
Standard Deviation 2.9
|
-6.2 units on a scale
Standard Deviation 3.7
|
-2.1 units on a scale
Standard Deviation 2.6
|
Adverse Events
R348 Ophthalmic Solution, 0.2%
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
R348 Ophthalmic Solution, 0.5%
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R348 Ophthalmic Solution, 0.2%
n=11 participants at risk
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
|
R348 Ophthalmic Solution, 0.5%
n=12 participants at risk
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
|
Placebo
n=12 participants at risk
Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hyperbilirubinaemia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Clostridium Difficile infection
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Vascular disorders
Microembolism
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
Other adverse events
| Measure |
R348 Ophthalmic Solution, 0.2%
n=11 participants at risk
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
|
R348 Ophthalmic Solution, 0.5%
n=12 participants at risk
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
|
Placebo
n=12 participants at risk
Placebo Ophthalmic Solution 2 drops per eye twice a day
Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hyperbilirubinaemia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Ocular Hyperaemia
|
18.2%
2/11 • Number of events 4 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Blepharitis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Corneal Deposits
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Dry Eye
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Eye Irritation
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Posterior Capsule Opacification
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Punctate Keratitis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
16.7%
2/12 • Number of events 3 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
16.7%
2/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Trichiasis
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Cataract
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Cataract Nuclear
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Corneal Opacity
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Diplopia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Eye Pain
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Eyelid Ptosis
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Iris Adhesions
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Keratitis
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Meibomian Gland Dysfunction
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Optic Nerve Cupping
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Retinal Pigmentation
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 3 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
General disorders
Instillation Site Pain
|
18.2%
2/11 • Number of events 4 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
General disorders
Instillation Site Foreign Body Sensation
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
General disorders
Secretion Discharge
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Hepatobiliary disorders
Cholangitis Sclerosing
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Immune system disorders
Seasonal Allergy
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Immune system disorders
Graft Versus Host Disease
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
2/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Arthritis Bacterial
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Oral Infection
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Sinusitis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Skin Infection
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Urinary Tract Infection
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
25.0%
3/12 • Number of events 3 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
16.7%
2/12 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Investigations
Intraocular Pressure Increased
|
9.1%
1/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Nervous system disorders
Seizure
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Psychiatric disorders
Restlessness
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • Number of events 2 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Parosmia
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Irritation
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Vascular disorders
Microembolism
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Vascular disorders
Ecchymosis
|
9.1%
1/11 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/11 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
0.00%
0/12 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
8.3%
1/12 • Number of events 1 • The AE reporting period begins with the first dose of study drug and ends with the final study follow-up visit (Day 91).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place