Trial Outcomes & Findings for Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME) (NCT NCT03466099)
NCT ID: NCT03466099
Last Updated: 2021-01-28
Results Overview
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
16 weeks
Results posted on
2021-01-28
Participant Flow
130 Patients were randomized but one patient withdrew prior to receiving any study treatments
Participant milestones
| Measure |
KVD001 Injection (High Dose)
KVD001 Injection: Intravitreal KVD001 6μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12.
|
KVD001 Injection (Low Dose)
KVD001 Injection: Intravitreal KVD001 3μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12.
|
Sham Procedure
Sham Procedure: Sham Procedure performed on the study eye on Day 1 and Weeks 4, 8 and 12 which involved preparing the study subject in the same manner as a real injection would be prepared (i.e., including but not limited to insertion of lid speculum, application of povidone-iodine, and subconjunctival injection of an anesthetic, all applied to the study eye) after which an empty syringe without an attached needle was pressed against the eye to mimic the pressure of an injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
44
|
45
|
|
Overall Study
Treated
|
41
|
44
|
44
|
|
Overall Study
COMPLETED
|
24
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
17
|
14
|
17
|
Reasons for withdrawal
| Measure |
KVD001 Injection (High Dose)
KVD001 Injection: Intravitreal KVD001 6μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12.
|
KVD001 Injection (Low Dose)
KVD001 Injection: Intravitreal KVD001 3μg Injection administered to the study eye on Day 1 and Weeks 4, 8 and 12.
|
Sham Procedure
Sham Procedure: Sham Procedure performed on the study eye on Day 1 and Weeks 4, 8 and 12 which involved preparing the study subject in the same manner as a real injection would be prepared (i.e., including but not limited to insertion of lid speculum, application of povidone-iodine, and subconjunctival injection of an anesthetic, all applied to the study eye) after which an empty syringe without an attached needle was pressed against the eye to mimic the pressure of an injection
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
|
Overall Study
Use of rescue medication
|
8
|
9
|
13
|
|
Overall Study
Rescued without meeting criteria
|
4
|
1
|
1
|
|
Overall Study
Subject compliance
|
2
|
0
|
0
|
|
Overall Study
Worsening disease
|
0
|
0
|
1
|
Baseline Characteristics
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
Baseline characteristics by cohort
| Measure |
KVD001 Injection (High Dose)
n=41 Participants
KVD001 Injection: Intravitreal KVD001 Injection 6ug
|
KVD001 Injection (Low Dose)
n=44 Participants
KVD001 Injection: Intravitreal KVD001 Injection 3ug
|
Sham Procedure
n=44 Participants
Sham Procedure: Sham Procedure
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.58 • n=99 Participants
|
61.1 years
STANDARD_DEVIATION 10.67 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 8.62 • n=206 Participants
|
63.0 years
STANDARD_DEVIATION 9.70 • n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
111 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Iris color
Black
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Iris color
Blue
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Iris color
Brown
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
|
Iris color
Hazel
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Iris color
Green
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Iris color
Gray
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Baseline Height (cm)
|
167.98 cm
STANDARD_DEVIATION 10.833 • n=99 Participants
|
169.21 cm
STANDARD_DEVIATION 11.579 • n=107 Participants
|
164.78 cm
STANDARD_DEVIATION 12.638 • n=206 Participants
|
167.31 cm
STANDARD_DEVIATION 11.788 • n=7 Participants
|
|
Baseline Weight (kg)
|
88.88 kg
STANDARD_DEVIATION 13.605 • n=99 Participants
|
94.94 kg
STANDARD_DEVIATION 26.404 • n=107 Participants
|
85.34 kg
STANDARD_DEVIATION 20.139 • n=206 Participants
|
89.74 kg
STANDARD_DEVIATION 21.083 • n=7 Participants
|
|
Baseline BMI
|
31.71 kg/(m*m)
STANDARD_DEVIATION 5.367 • n=99 Participants
|
33.00 kg/(m*m)
STANDARD_DEVIATION 7.728 • n=107 Participants
|
31.58 kg/(m*m)
STANDARD_DEVIATION 6.999 • n=206 Participants
|
32.11 kg/(m*m)
STANDARD_DEVIATION 6.778 • n=7 Participants
|
PRIMARY outcome
Timeframe: 16 weeksChange from Baseline in Best Corrected Visual Acuity (BCVA)
Outcome measures
| Measure |
KVD001 Injection (High Dose)
n=40 Participants
KVD001 Injection: Intravitreal KVD001 Injection 6ug
|
KVD001 Injection (Low Dose)
n=44 Participants
KVD001 Injection: Intravitreal KVD001 Injection 3ug
|
Sham Procedure
n=44 Participants
Sham Procedure: Sham Procedure
|
|---|---|---|---|
|
BCVA
|
0.8 Letters
Standard Deviation 6.65
|
-0.3 Letters
Standard Deviation 8.36
|
-1.8 Letters
Standard Deviation 12.27
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS Population with observed data
Assessments of Diabetic Retinopathy Severity Score (DRSS, scale 10-85) to evaluate the percentage of eyes with a ≥2 step reduction in score from the baseline retinopathy severity as graded from fundus photography. Minimum and maximum values of the DRSS are 10 and 85, with the low end of the scale indicating absence of retinopathy which, as the score increases, so does the severity of the retinopathy such that a score of 85 is indicative of advanced proliferative diabetic retinopathy
Outcome measures
| Measure |
KVD001 Injection (High Dose)
n=29 Participants
KVD001 Injection: Intravitreal KVD001 Injection 6ug
|
KVD001 Injection (Low Dose)
n=31 Participants
KVD001 Injection: Intravitreal KVD001 Injection 3ug
|
Sham Procedure
n=29 Participants
Sham Procedure: Sham Procedure
|
|---|---|---|---|
|
DRSS
|
0 percentage of participants
Interval 0.0 to 0.0
|
3.2 percentage of participants
Interval 0.1 to 16.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: FAS Population with LOCF
Assessments of Central Subfold Thickness (CST) - analysis of covariance of change from baseline in the study eye at week 16
Outcome measures
| Measure |
KVD001 Injection (High Dose)
n=40 Participants
KVD001 Injection: Intravitreal KVD001 Injection 6ug
|
KVD001 Injection (Low Dose)
n=44 Participants
KVD001 Injection: Intravitreal KVD001 Injection 3ug
|
Sham Procedure
n=44 Participants
Sham Procedure: Sham Procedure
|
|---|---|---|---|
|
CST
|
10.9 μm
Standard Deviation 104.67
|
2.3 μm
Standard Deviation 108.83
|
8.2 μm
Standard Deviation 123.90
|
Adverse Events
KVD001 Injection (High Dose)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
KVD001 Injection (Low Dose)
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KVD001 Injection (High Dose)
n=41 participants at risk
KVD001 Injection: Intravitreal KVD001 Injection 6ug
|
KVD001 Injection (Low Dose)
n=44 participants at risk
KVD001 Injection: Intravitreal KVD001 Injection 3ug
|
Sham Procedure
n=44 participants at risk
Sham Procedure: Sham Procedure
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
4.5%
2/44 • Number of events 2 • 28 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Localized infection
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Staphylococcal infection
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
Other adverse events
| Measure |
KVD001 Injection (High Dose)
n=41 participants at risk
KVD001 Injection: Intravitreal KVD001 Injection 6ug
|
KVD001 Injection (Low Dose)
n=44 participants at risk
KVD001 Injection: Intravitreal KVD001 Injection 3ug
|
Sham Procedure
n=44 participants at risk
Sham Procedure: Sham Procedure
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
6.8%
3/44 • Number of events 3 • 28 Weeks
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Macular oedema
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Eye Pain
|
4.9%
2/41 • Number of events 2 • 28 Weeks
|
6.8%
3/44 • Number of events 3 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Retinal aneurysm
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Retinopathy
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
General disorders
Oedema peripheral
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
4.5%
2/44 • Number of events 2 • 28 Weeks
|
|
General disorders
Pyrexia
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Infections and infestations
Urinary tract infection
|
7.3%
3/41 • Number of events 3 • 28 Weeks
|
4.5%
2/44 • Number of events 2 • 28 Weeks
|
9.1%
4/44 • Number of events 4 • 28 Weeks
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Blood glucose fluctuations
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Blood urea increased
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Blood uric acid increased
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Medication residue present
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Vascular disorders
Hypertension
|
7.3%
3/41 • Number of events 4 • 28 Weeks
|
9.1%
4/44 • Number of events 5 • 28 Weeks
|
6.8%
3/44 • Number of events 3 • 28 Weeks
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Visual impairment
|
0.00%
0/41 • 28 Weeks
|
9.1%
4/44 • Number of events 4 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Vitreous haemorrhage
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Catatact
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
4.5%
2/44 • Number of events 3 • 28 Weeks
|
|
Eye disorders
Eye irritation
|
4.9%
2/41 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Vision blurred
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Vitreous detachment
|
4.9%
2/41 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Conjunctival follicles
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Detachment of macular retinal pigment
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Diplopia
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Dry eye
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Lacrimation increased
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Eye disorders
Retinal neovascularisation
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Eye disorders
Retinal vessel avulsion
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Gastrointestinal disorders
Haematemesis
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
General disorders
Asthenia
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
General disorders
Facial pain
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
General disorders
Fatigue
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 4 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 2 • 28 Weeks
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/41 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Cellulitis staphylococcal
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Abscess limb
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Influenza
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Staphylococcal abscess
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Staphylococcal infection
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Infections and infestations
Tooth infection
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/41 • 28 Weeks
|
4.5%
2/44 • Number of events 2 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/41 • 28 Weeks
|
4.5%
2/44 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Blood triglycerides increased
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Investigations
Intraocular pressure increased
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Investigations
Urine albumin/creatinine ratio increased
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.9%
2/41 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
2.4%
1/41 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Nervous system disorders
Disarthria
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.4%
1/41 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/41 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 1 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/41 • 28 Weeks
|
2.3%
1/44 • Number of events 2 • 28 Weeks
|
0.00%
0/44 • 28 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60