Trial Outcomes & Findings for Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis (NCT NCT01195948)
NCT ID: NCT01195948
Last Updated: 2018-09-11
Results Overview
Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system. The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
B27PD 1 mg
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
B27PD 4 mg
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
Placebo
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
|
Overall Study
Week 24
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
B27PD 1 mg
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
B27PD 4 mg
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
Placebo
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
Baseline Characteristics
Optiquel® as Corticosteroid-sparing Therapy for Chronic Noninfectious Uveitis
Baseline characteristics by cohort
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
Placebo
n=11 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
43 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
43 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
45 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeksRecurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system. The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation.
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=11 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.
|
52 weeks
Interval 52.0 to 52.0
|
52 weeks
Interval 28.29 to 52.0
|
45 weeks
Interval 10.0 to 52.0
|
SECONDARY outcome
Timeframe: Week 24Population: Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.
Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=10 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
|
1 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 52Population: Twenty-five (25) participants completed Week 52. Three completed prior to Week 52 as a result of early study closure (1/group), two placebo participants and one 4 mg participant were lost to follow-up at Weeks 10, 44 and 28, respectively.
Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system
Outcome measures
| Measure |
B27PD 1 mg
n=9 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=8 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=8 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters
|
1 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=10 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline
|
1.50 ETDRS letters
Interval -2.0 to 7.0
|
2.10 ETDRS letters
Interval -3.0 to 6.0
|
2.80 ETDRS letters
Interval -3.0 to 12.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=10 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline
|
2.80 ETDRS letters
Interval -5.0 to 8.0
|
2.00 ETDRS letters
Interval -5.0 to 5.0
|
0.50 ETDRS letters
Interval -4.0 to 5.0
|
SECONDARY outcome
Timeframe: Week 24Population: Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=10 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline
|
9 participants
|
9 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Week 24Population: Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=10 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline
|
10 participants
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Week 24Population: This outcome was not analyzed as no data was collected at Week 24.
This outcome was not analyzed as no data was collected at Week 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.
Outcome measures
| Measure |
B27PD 1 mg
n=10 Participants
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 Participants
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=10 Participants
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Changes in High-speed Indocyanine Green Angiography (HS-ICG)
Decrease
|
0 participants
|
2 participants
|
0 participants
|
|
Changes in High-speed Indocyanine Green Angiography (HS-ICG)
No change
|
10 participants
|
7 participants
|
10 participants
|
|
Changes in High-speed Indocyanine Green Angiography (HS-ICG)
Increase
|
0 participants
|
1 participants
|
0 participants
|
Adverse Events
B27PD 1 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
B27PD 4 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B27PD 1 mg
n=10 participants at risk
Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
B27PD 4 mg
n=10 participants at risk
Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
B27PD
|
Placebo
n=11 participants at risk
Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
Placebo: Capsule with no active ingredients to mimic B27PD
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Maximum of 52 weeks
|
20.0%
2/10 • Number of events 2 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 2 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Investigations
Blood pressure increased
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
20.0%
2/10 • Number of events 3 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Investigations
Blood urine
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Investigations
Blood urine present
|
20.0%
2/10 • Number of events 3 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Investigations
Creatine urine increased
|
10.0%
1/10 • Number of events 2 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Surgical and medical procedures
Dental operation
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 3 • Maximum of 52 weeks
|
20.0%
2/10 • Number of events 2 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Eye disorders
Eye irritation
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 4 • Maximum of 52 weeks
|
|
Eye disorders
Eye pain
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Eye disorders
Eye pruritis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Eye disorders
Eyelid oedema
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal tract irritation
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Investigations
Haemoglobin urine
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 3 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 3 • Maximum of 52 weeks
|
|
Investigations
Heart rate increased
|
10.0%
1/10 • Number of events 2 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Helicobacter gastritis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Herpes zoster
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • Number of events 2 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
General disorders
Influenza like illness
|
40.0%
4/10 • Number of events 4 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Investigations
Intraocular pressure increased
|
10.0%
1/10 • Number of events 6 • Maximum of 52 weeks
|
20.0%
2/10 • Number of events 3 • Maximum of 52 weeks
|
36.4%
4/11 • Number of events 5 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • Number of events 4 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal chest pain
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10 • Number of events 3 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
27.3%
3/11 • Number of events 4 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Maximum of 52 weeks
|
20.0%
2/10 • Number of events 2 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Periorbital cellulitis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Number of events 4 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Investigations
Red blood cells urine
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Immune system disorders
Sarcoidosis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Sinusitis
|
30.0%
3/10 • Number of events 3 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
20.0%
2/10 • Number of events 3 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
General disorders
Thirst
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Investigations
Urine analysis abnormal
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Investigations
Urine ketone body present
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Investigations
Urine leukocyte esterase positive
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
18.2%
2/11 • Number of events 2 • Maximum of 52 weeks
|
|
Investigations
White blood cells urine
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/10 • Maximum of 52 weeks
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Eye disorders
Photophobia
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/11 • Maximum of 52 weeks
|
|
Eye disorders
Photopsia
|
10.0%
1/10 • Number of events 1 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
|
Eye disorders
Pupils unequal
|
0.00%
0/10 • Maximum of 52 weeks
|
0.00%
0/10 • Maximum of 52 weeks
|
9.1%
1/11 • Number of events 1 • Maximum of 52 weeks
|
Additional Information
Robert Nussenblatt, MD, MPH
National Institutes of Health
Phone: 301-496-3123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place